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Antimicrobial resistance (AMR) in bacteria (often referred to as antibiotic resistance) is one of the major public health challenges of our time. AMR can be described as the ability of a bacterium to withstand the effects of an antimicrobial agent. In addition to antimicrobial agents used for treatment and prophylaxis in humans, animals, and plants, chemical susbtances, such as biocides and heavy metals, may also induce resistance in bacteria against antimicrobial agents used in human and veterinary medicine. In June 2016, the Norwegian Environment Agency requested the Norwegian Scientific Committee for Food Safety (VKM) to conduct a literature review regarding development of bacterial resistance to biocides and heavy metals and cross-resistance to antimicrobial agents (e.g., antibiotics) in bacteria, with the following mandate: 1. List chemical substances that may contribute to increased antimicrobial resistance. 2. Describe the substances listed in question 1 that are used/in use in Norway and assess which fields of applications that have the potential to contribute to increased resistance. 3. Range the substances according to field of application that is assumed to have the strongest effect on development of resistance, based on characteristics and amount used. 4. Identify knowledge gaps according to the effect of these substances on development of resistance. In order to answer the mandate, VKM appointed a working group consisting of two members of the Panel on Microbial Ecology, and one external expert, to prepare a draft opinion document and answer the questions. The Panel on Microbial Ecology has reviewed and revised the draft prepared by the working group and approved the opinion document “Antimicrobial resistance due to the use of biocides and heavy metals: a literature review”. A biocide is defined as an active chemical molecule that controls the growth of, or kills, bacteria and other microorganisms in a biocidal product. The biocides are classified into 4 main groups according to their application categories and further sub-divided into 23 product groups. In this assessment, we focus on biocides with potential antibacterial activity and their ability to induce antimicrobial (antibiotic) resistance in bacteria. These products belong mostly to main group 1; Disinfectants. Disinfectants include products used in human hygiene, veterinary hygiene, water treatment, and products used in the field of food and feed, but excludes cleaning products that are not intended to have a biocidal effect, including washing liquids, powders, and similar products. Heavy metals are naturally occurring elements that have a high atomic weight and a density that is at least 5 times greater than that of water. Some heavy metals have been used as antimicrobial agents since antiquity, but often their modes of action have remained unclear. They are able to induce toxicity at low levels of exposure. In this report we have chosen to include the following elements in the category “heavy metals”: silver (Ag), arsenic (As), cadmium (Cd), copper (Cu), mercury (Hg), and zinc (Zn). The selection is based on their area of use and on their ability to induce AMR. Although most biocides and heavy metals are known to be high volume products, the working group was not able to obtain detailed data on the amounts used in Norway. However, there is no doubt that the production and usage volumes and the area of application for several of these substances are several orders of magnitude higher than those of antimicrobial agents used in therapy and prophylaxis. This Opinion document is not a traditional risk assessment, but a literature study that presents and compiles the available information regarding resistance development in bacteria due to use/misuse of biocides and heavy metals. Exposure assessment and risk characterization have therefore been excluded. The following definitions regarding probability of biocides and heavy metals inducing AMR in bacteria are used: Highly likely - is expected to occur in most circumstances Likely - could occur in many circumstances Unlikely - could occur in some circumstances Highly unlikely (effectively zero) - may occur only in very rare circumstances The most commonly used chemical substances with the potential to induce AMR and cross or co-resistance in bacteria are the heavy metals, copper, zinc, and cadmium (“highly likely”). Phenols, especially triclosan, surface-active agents, especially quaternary ammonium compounds (QACs), and the heavy metals arsenic and mercury are classified in the category “likely”. The components in the “unlikely” group are aldehydes, biguanides, organic acids, inorganic acids, antimicrobial dyes, diaminides, and silver. It should be noted that a number of uncertainties are associated with assigning these substances to particular categories of probabilities/likelihoods (highly likely, likely, unlikely, and highly unlikely) in this assessment. Bacteria are living organisms that are continually changing their genetic compositions, and are able to adapt rapidly to altered living conditions. Furthermore, the concentrations of the substances to which the bacteria are exposed affects the probability of inducing resistance. This report reviews the literature describing the current situation with regards to development of resistance in bacteria due to biocides and heavy metals. The current situation and genetic and phenotypic status may change as bacteria continue to adapt to exposure to biocides/heavy metals and antimicrobial agents at varying doses, durations, and combinations. Data gaps There is a lack of knowledge regarding the diverse reservoir of AMR in the environment including soil, sediment, water, air, wild plants, and animals that are impacted by biocides and heavy metals. We have not been able to gather sufficient data on the amount of the different biocides and heavy metals that end up, unintentionally, in the environment in Norway and the extent to which such exposure, alone or in combination with other antimicrobials, may result in development of AMR in microbial communities. Furthermore, limited data are available regarding use/misuse/presence of biocides and heavy metals in consumer products. Knowledge regarding development of resistance in bacteria due to use of biocides or heavy metals in cosmetic products is lacking., NO; PDF; vkm@vkm.no

The Norwegian Environment Agency and the Norwegian Food Safety Authority asked the Norwegian Scientific Committee for Food and Environment to assess the risk to Norwegian biodiversity, to the productivity of native salmonid populations, and to aquaculture, from the spread and establishment of pink salmon in Norwegian rivers, and to assess mitigation measures to prevent the spread and establishment of this alien species. Pink salmon is native to rivers around the northern Pacific Ocean. The species usually has a strict two-year life cycle, with populations spawning in even and odd years being genetically isolated. Fertilized eggs of pink salmon were transferred from Sakhalin Island to Northwest Russia in the late 1950s, and fry were released in rivers draining to the White Sea. The first abundant return to rivers in Northwest Russia, as well as to Norway and other countries in northwestern Europe, was recorded in 1960. Stocking with fish from Sakhalin was terminated in 1979. By then, no self-sustaining populations had been established. From 1985 onwards, stocking in White Sea rivers was resumed with fish from rivers in the more northerly Magadan oblast on the Russian Pacific, resulting in the establishment of reproducing populations. Stocking was continued until 1999, when the last batch of even-year fertilized eggs was imported, and the fry released in spring 2000. Thus, all pink salmon caught after 2001 in the Northeast Atlantic and the Atlantic side of the Arctic Ocean including the Barents Sea, as well as in rivers draining into these seas, are the result of reproduction in the wild. Pink salmon is now established with abundant and increasing stocks in Northwest Russia and regular occurrence in rivers in eastern Finnmark. Catches of odd-year adult pink salmon in Northwest Russia were usually below 100 tonnes before 2001 and increased to an annual average of 220.5 tonnes during the period 2001-2017. Even-year returns are smaller than odd-year returns both in Northwest Russia and in Norway. The number of pink salmon recorded in Norwegian rivers peaked in 2017, with a high number of fish in eastern Finnmark, and substantial numbers recorded in rivers all along the coast of Norway and in other European countries. In 2019, the area with abundant returns expanded in comparison with 2017, to include rivers in western Finnmark and Troms. The recorded numbers were perhaps lower in southern Norway in 2017 than in 2019 (full statistics not available when this report was finalised), but also in southern Norway there were more pink salmon in 2019 than in any year before 2017. The large numbers of pink salmon in western Finnmark and Troms in 2019 may indicate an expansion of the area in Norway with abundant odd-year pink salmon returns. In some small rivers in eastern Finnmark, between 1000 and 1500 pink salmon were fished out by local people in 2019, demonstrating the magnitude of the potential impact in terms of numbers of pink salmon. We cannot rule out that this will not happen over larger parts of Norway in the coming years. The even-year strain of pink salmon only occurs in low numbers in Russian rivers, as well as Norwegian, rivers. Adult pink salmon enter the rivers from early July, and spawning occurs in August-September. Spawning habitat requirements are like those of native salmonids: Atlantic salmon, brown trout, and Arctic charr. Spawning of pink salmon occurs earlier than the native salmonids, but observations in 2019 indicate a possible overlap with native salmonids in September in northern Norway. Pink salmon eggs hatch in late winter or spring, and the alevins remain in the gravel until most of the yolk sac has been resorbed. Emerging fry are approximately 30 mm in length. Functionally, they are smolt already at this stage, with a silvery colouration and saltwater tolerance. The fry/smolt start feeding on small invertebrates in some rivers, while the fry/smolt migrate without feeding in other rivers. They impact juveniles of native salmonids through competition for food and space and the invertebrate fauna through predation. The impact depends on the duration of their stay. This is assumed to be very short, but some observations indicate that fry/smolt that emerge from spawning redds far upstream may feed and grow to 60-70 mm before entering the sea. Pink salmon smolt may spend some time in estuaries and coastal waters before moving to the open sea. The next approximately 12 months are spent feeding in the open seas before returning to the coast to seek rivers for spawning. Homing is less precise in pink salmon than in other anadromous salmonids. All spawners die shortly after spawning. Methods This risk assessment is based on an extensive literature search, contact with scientists in North America, western Europe, Russia, Norway, the county governor in Troms and Finnmark, and local anglers’ associations, and other stakeholders in Norway. We have investigated whether ocean temperatures play an important role in the variation of pink salmon year class abundance, and whether the annual abundance of adult pink salmon is increasing with rising sea temperatures. This is an important aspect of a risk assessment in a 50-yr perspective. We have used a semi-quantitative risk assessment. The overall risk is the product of the magnitude of the consequences of the event and the likelihood that the event will occur, as judged by the project group experts. The level of confidence in the risk assessment is described, and uncertainties and data gaps identified. Results The dynamics and environmental impact of introduced pink salmon in Norwegian rivers, coastal waters, and the ocean, depend on their abundance. In all habitats and for all life stages, high abundance may have serious repercussions, whereas low numbers may be of little consequence. An increasing abundance of reproducing pink salmon will likely present hazards to biodiversity and river ecosystems. Establishment of reproducing pink salmon over larger areas in Norway will probably increase the regularity of abundant returns to Norwegian waters. The invertebrate fauna will be negatively affected where large numbers of pink salmon juveniles use it as a food source. This is more likely in long than in short rivers. The river pearl mussel, Margaritifera margaritifera, may be particularly vulnerable, as it has a larval stage in juvenile Atlantic salmon or brown trout, but cannot use pink salmon as a host. Pathogens that may be affected by the increased occurrence of pink salmon in Norway include viruses, bacteria, and parasites (eukaryotic organisms). Very little is known about the susceptibility of pink salmon to viral pathogens. Among 11 viral pathogens assessed, only three or four are known to infect pink salmon. The project group assesses that the potential impact for aquaculture is moderate if infectious haematopoietic necrosis virus is spread by pink salmon in the marine ecosystems. Salmonid alphavirus (SAV)-infected pink salmon, potentially infected through contact with Atlantic salmon aquaculture, moving from south to north could introduce a risk of spread of this virus and the resulting pancreas disease. The project group assesses that the overall potential impact of SAV for aquaculture in the marine ecosystems is low with medium to low confidence. The project group assesses that the potential impacts for aquaculture if Renibacterium salmoninarum and Piscirickettsia salmonis are spread by pink salmon in the marine ecosystems are moderate with low confidence. The potential negative impact on biodiversity in the marine ecosystems and productivity of native salmonid species is assessed as low to minimal for all viral and bacterial pathogens considered, apart from for Renibacterium salmoninarum and viral haemorrhagic septicaemia virus for which the risks were assessed as moderate. Parasites can potentially represent a major hazard to both wild and farmed salmonids, and we have considered three groups of parasites; (1) those that may impact the health and welfare of native salmonids (in the wild and in aquaculture), (2) zoonotic parasites, and (3) aquatic organisms that have a parasitic stage in their life cycle, but are of relevance and interest in Norwegian ecosystems. The abundance and spread of some of these parasites may be affected by the incursion of pink salmon. Hybridization between pink salmon (genus Oncorhynchus) and native salmonids (genera Salmo and Salvelinus) has not been documented in the wild. In the laboratory, intergeneric hybridizations between these species have produced only sterile offspring. Interactions with native salmonids may occur in two ways: through competition for food or through competition for space in the river before spawning and on the spawning grounds. If feeding in the river, pink salmon fry ingest the same prey as native salmonid fry. Thus, competition for food and space may occur if there are high densities of pink salmon for a substantial period. High densities of pink salmon fry may also influence the ability of native salmonid fry to establish territories. On the other hand, emerging pink salmon fry may serve as food for older life stages of native salmonids. Competition for spawning grounds may be restricted due to pink salmon spawning earlier in the autumn. However, there may be temporal overlap between Arctic charr and pink salmon spawning in northern Norway, and a possible overlap in both time and space with early-spawning brown trout. High numbers of pink salmon spawners may have a crowding effect on native salmonids before the actual spawning time. Agonistic behaviour, like chasing of up-migrating Atlantic salmon and brown trout by pink salmon, is known to occur. The effect of this aggressive behaviour on the spawning success of native salmonids is not known. Pink salmon spawners transport organic matter and nutrients from the sea to the rivers. Water quality will be influenced by pink salmon carcasses in rivers after spawning. Decomposition of dead spawners will release organic matter and nutrients (phosphorous and nitrogen) into the water. In nutrient-poor rivers, this will enhance production of algae and zoobenthos, and likely benefit juvenile native salmonids. The impact will likely be negative in more nutrient-rich rivers. Any effect from nutrient input on water quality is likely governed by the number of dead fish, river morphology, and the current nutrient status of the river. Dead and decomposing spawners benefit scavengers of all types and may therefore also affect terrestrial food webs and biodiversity. In the coastal and marine systems, juvenile and adult pink salmon will constitute a new and additional prey for many predators. Pink salmon in the seas may feed on similar prey as native salmonids, and high densities of pink salmon may negatively affect native salmonids as well as the marine ecosystem, as seen in the North Pacific Ocean. Hazards for the aquaculture industry are mainly associated with spreading of disease-causing pathogens. This is directly related to the number of pink salmon in the waters around aquaculture installations. The higher the number of pink salmon, the higher is the probability of individuals carrying pathogens that may be transferred to aquaculture fish. If pink salmon come to dominate the number of salmonids in rivers, this will negatively affect both the economic value of salmon angling, and the value in terms of an important ecosystem service, as catches may be dominated by 1.5 kg fish (that are not fit for human consumption, except early in the season) compared with the larger Atlantic salmon. Under present climatic conditions, pink salmon may spawn and produce offspring in all rivers along the Norwegian coast. Regular occurrence of the odd-year strain has so far only been seen in rivers in eastern Finnmark, where we believe self-sustaining populations have been established. The change from 2017 to 2019 may indicate that the area with rivers receiving high numbers is expanding westwards and southwards into Troms. Establishment of self-sustaining populations depend, in general, on a suffiently high survival of offspring after hatching and when they leave the rivers, and during the marine phase. Abundant returns of pink salmon are correlated with ocean surface temperatures in the North Atlantic Ocean and Barents Sea. Using sea-surface temperature data from 1900 to 2019, we find that the number of pink salmon returning can be relatively well predicted (adjusted R2 > 0.5 for a positive relationship) by sea-surface temperature in the area south of Svalbard and of the cohort size two years previously for all three data sets considered. Hence, the increasing sea surface temperatures and reduced ice cover over the last 20 years may benefit pink salmon in the ocean and be one reason for the increasing number of pink salmon in Northwest Russian and Norwegian waters. However, the average surface temperature of the Arctic Ocean seems to be increasing so rapidly at present that the ecosystem is probably in flux. The effects of this rapid change are unpredictable; however, it is likely that a climate warming over the next 50 years will facilitate the establishment of circumpolar pink salmon populations in Arctic rivers. Whether a warmer climate will benefit pink salmon in all Norwegian rivers remains unclear, as it is considered a cold-water species. However, pink salmon seem to be able to adapt to new conditions over a few generations. Conclusions It has already been demonstrated that pink salmon can occur in large numbers and high densities in Norwegian rivers. The impact of pink salmon on biodiversity and ecosystems in Norwegian waters depends on their numbers. This is valid for all aspects of the river systems. A low number of pink salmon are likely of little consequence, whereas abundant spawning pink salmon in a river may have substantial impact on native salmonids, as well as on water quality and biodiversity. Thousands of spawners will possibly produce millions of offspring that may impact small invertebrates and crustaceans negatively and compete with native salmonids for food and space after hatching. The impact in the sea also depends on the abundance of pink salmon, as they may compete with native salmonids and other species for food as well as have other impacts on the food-web of marine ecosystem. The likelihood of spreading of disease to native wild fish, as well as to aquaculture fish, is also directly correlated with the number of pink salmon. However, only a few fish may have a serious impact if heavily infested with a pathogen to which native wild fish or aquaculture fish are susceptible, and conditions favour transmission. The current increasing trend in sea-surface temperatures and reduced ice cover seem to benefit the survival of pink salmon in the sea, and the projected climate change may enhance this. The impact of a warmer climate on the river stages of pink salmon is less clear. The effects of further climate change may introduce unexpected interactions with pathogens and with other species, as the accelerating change since about 2010 has been moving the Arctic Ocean into previously unobserved temperature regimes. Feasible measures to reduce the impact of pink salmon in rivers include targeted fishing adapted to local conditions. Experience from 2017 and 2019 shows that such efforts are effective and can decrease or even eliminate the threat of pink salmon to native salmonids and biodiversity in individual rivers, at least in smaller rivers. In order to reduce the number of pink salmon and the recurring returns of pink salmon spawners to Norwegian coastal waters and rivers in general, however, concerted action on a regional, national and international level is required.

Request from the Norwegian Food Safety Authority: Following a report from the National Nutrition Council calling for actions to secure adequate iodine intake in the population, the Norwegian Food Safety Authority requested the Norwegian Scientific Committee for Food and Environment (VKM) to conduct a benefit- and risk assessment of iodization of household salt and industrialised salt in bread. VKM addressed the request: VKM appointed a project group consisting of members of the Panel on Nutrition, Dietetic Products, Novel Food and Allergy and Panel on Contaminants to answer the request. The Panel on Nutrition, Dietetic Products, Novel Food and Allergy has reviewed and revised drafts prepared by the project group and finally approved the benefit- and risk assessment This benefit and risk assessment is based on 1) established knowledge about health consequences from severe iodine deficiency, 2) systematic literature review of the evidence for health consequences of mild to moderate iodine deficiency, 3) literature review of studies on adverse health effects from excessive iodine intakes to re-evaluate existing tolerable upper intake levels (ULs), 4) evaluation of estimated iodine intake levels in different population groups in Norway compared to established dietary reference values, specifically estimated average requirement (EAR) and UL, and finally 5) an estimation of the effect of different scenarios of increasing iodization levels in household salt and salt in bread on iodine intake levels in different population groups compared to the established dietary reference values EAR and UL. For the purpose of this benefit and risk assessment of iodization in household salt and salt in bread, risk may be understood as risk of adverse health effects related to too high or too low iodine intakes. Benefit may be understood as reduction or avoidance of adverse health effects related to too high or too low iodine intakes. For iodine, this is a challenging maneuver, as the gap between too low and too high intakes is narrow. The project group conducted two systematic literature reviews. One was performed to evaluate the evidence for the impact of mild- to moderate iodine deficiency on neurodevelopment, thyroid function and birth outcomes, the other to evaluate the evidence for adverse health effects from excessive iodine intake to possibly re-evaluate the existing tolerable upper intake levels. Current evidence for adverse health effects of iodine deficiency: Severe iodine deficiency resulting in hypothyroidism during foetal life, infancy, or early childhood may lead to permanent intellectual disability. Severe maternal iodine deficiency in pregnancy may also result in miscarriages, preterm delivery, stillbirth, and congenital abnormalities. These effects are due to low levels of thyroid hormones affecting the developing tissues. The health effects of severe iodine deficiency are well established, but for mild to moderate deficiency the effects are less known. After screening of more than 15 000 titles and abstracts and quality assessment of 131 full text scientific papers, 36 publications were included for the grading of evidence for consequences of mild to moderate iodine deficiency. We used the criteria proposed by the World Cancer Research Fund for grading of evidence. Based on our systematic literature review, the evidence for adverse effects from mild to moderate iodine deficiency and neurodevelopment was judged to meet the criteria for limited suggestive. Limited suggestive means that the evidence is too limited to permit a probable or convincing causal judgement but shows a generally consistent direction of effect. It was further concluded that there is limited (no conclusion) evidence to support that mild to moderate iodine deficiency causes thyroid dysfunction or has negative effects on birth outcomes. Limited (no conclusion) means that the evidence is so limited that no firm conclusion can be made. Established reference values for iodine requirement: Several competent bodies have established dietary reference values for iodine. We have based this benefit and risk assessment on estimated average requirements (abbreviated EAR or AR) from the Nordic Nutrition Recommendations (2012) for adults, and from the Institute of Medicine (2001) for adolescents and children. Estimated average requirement is an iodine intake that is estimated to meet the requirement of half the healthy individuals in the population. The iodine intake is considered to be adequate if 97.5% of a population has a habitual intake above the estimated average requirement. Re-evaluation of tolerable upper intake levels: As the evidence for health effects of excessive iodine intakes is far less comprehensive than for iodine deficiency, we did not aim at evaluating the literature for excess intakes with the same weight of evidence tools as for deficiency. We have only evaluated whether recent literature is in line with the existing tolerable upper intake levels or if it supports that tolerable upper intake levels should be changed. Generally, UL is the maximum level of total chronic daily intake judged to be unlikely to pose a risk of adverse health effects, and in the case of iodine the UL for adults is the maximum daily intake where changes in TSH are unlikely to occur (SCF, 2002). After screening more than 2500 titles and abstracts, five studies fulfilled the inclusion criteria and were found relevant and included for evaluation of existing ULs. The existing ULs from the Scientific Committee on Food from 2001 is maintained. However, according to findings in new studies, the lowest-observed-adverse-effect levels (LOAEL) for excessive iodine intake may be lower than previously assumed, and the uncertainty factor inherent in the established ULs is reduced from three to 1.3 for adults. The findings also indicate a reduced LOAEL for the existing ULs in children. Changes in thyroid stimulating hormone (TSH) without changes in thyroid hormones (T3 or T4), that is subclinical hypothyroidism, are observed in one randomised controlled dose-response study and four cross-sectional studies in children at iodine intakes close to the ULs. Subclinical hypothyroidism is not considered to be harmful, but may progress into overt hypothyroidism. Iodine intake in Norwegian population groups and implications of salt iodization: Iodine intakes in adults are higher in men than in women and increase with increasing age for both sexes. Women of childbearing age and 13-year-old girls have the lowest estimated iodine intakes. 26% of the women of childbearing age have intakes below the estimated average requirement of 100 µg/day, and 38% of the 13-year-old girls have intakes below the estimated average requirement of 73 µg/day. The estimated iodine intakes in the 5th percentile of women of childbearing age and 13-year-olds is 70 and 38 µg/day, respectively. All adults and 13-, 9- and 4- year-olds have individual intakes below the tolerable upper intake levels. The estimates for 2-year-olds show that 9% have intakes below the estimated average requirement, and 8% have intakes above the tolerable upper intake level. The estimated iodine intake in the 95th percentile is 215 µg/day, slightly above the tolerable upper intake level of 200 µg/day. The estimates for non-breastfed 1-year-olds show that 8% have intakes below the estimated average requirement, and 18% have intakes above the tolerable upper intake level. The estimated iodine intake in the 95th percentile for this group is 259 µg/day. We present 12 scenario tables combining three scenarios (household salt alone, salt in bread alone and both household salt and salt in bread) with four iodization levels (15, 20, 25 and 50 mg iodine per kg salt). The percentages of the population groups with intakes above the estimated average requirement increases with increasing iodization levels, but so does the percentages with intakes above tolerable upper intake levels for some groups of the population. The scenarios that seem to elevate iodine intakes in women of childbearing age and 13-yearolds up to adequate intakes, are iodization up to 15 or 20 mg iodine per kg salt, including iodization of salt in bread. Above these iodization levels, no increased benefit would be expected in women of childbearing age and 13-year-olds. For 1- and 2-year-olds all scenarios lead to an increase in the proportion of toddlers with estimated intakes above the tolerable upper intake level. Benefit- and risk characterisation of iodization of household salt and industrialised salt in bread: Low estimated iodine intakes in adolescents (13-year-olds) and women of childbearing age (18-45 years) cannot be sufficiently corrected by the proposed increased iodization levels of salt and/or bread without imposing high iodine intakes in 1- and 2-year-old children. VKM assumes that the women of childbearing age and 13-year-olds will benefit from increased iodization levels in salt and bread. This will also benefit other groups that, for various reasons, have few iodine-rich sources in their diet, e.g., people who do not eat lean fish or consume milk or other dairy products. The risk imposed on the youngest age groups is a higher proportion of the 1- and 2-year-olds with iodine intakes above the tolerable upper intake level. Based on the scientific evidence and the data presented in this benefit and risk assessment it cannot be concluded that a specific iodization level benefits all age and gender groups without posing increased risk of harm to others or that the benefits in one population group outweighs the risks in others, or that the benefits in one group outweigh the risks in others. It should be noted that recommendations for nutrients are set to secure adequate growth, development, maintenance of health, and to reduce the risk of chronic illnesses. Thus, iodine intakes below EAR or above UL will decrease the possibilities of achieving the beneficial effects of adequate intake. Current iodine intake in certain population groups is worryingly low, and trend studies indicate that consumption of milk and dairy products in Norway, the most significant iodine sources in the diet, is declining, especially among young women. Several studies show that especially adolescents and women of childbearing age have insufficient iodine intakes, which may leave some at risk of severe iodine deficiency. There are, however, to our knowledge, no data on the prevalence of severe iodine deficiency in Norway. In other words, we do not know how many, if any, there are who have clinical consequences of inadequate iodine intakes. The scenarios that seem to elevate iodine intakes in women of childbearing age and 13-year olds (the groups at highest risk of low intakes) to adequate levels are iodization up to 15 or 20 mg iodine per kg salt, including iodization of salt in bread. Above these iodization levels, no increased benefit would be expected in women of childbearing age and 13-year-olds whereas several population groups will be at risk of exceeding UL, especially in 1- and 2-year-olds. The WHO recommends salt as a vehicle for correcting iodine deficiency in a population, followed by a close monitoring of the iodization program.

Unless comprehensive steps are taken to tackle Chronic Wasting Disease (CWD), it will continue to spread within the Norwegian cervid population. The disease will not disappear by itself. This is the main conclusion of a new risk assessment report published by the Norwegian Scientific Committee for food safety (VKM). The Norwegian Food Safety Authority (Mattilsynet, NFSA) and the Norwegian Environment Agency (Miljødirektoratet, NEA) requested the Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) for a scientific opinion on Chronic wasting disease (CWD) in cervids. The project was divided into two phases, and VKM published the scientific opinion from phase I “CWD in Norway” in June 2016. The current report is the result of phase II. VKM was asked to provide updated information on food safety, aspects important for transmission of CWD within and between populations and species, and the potential origin of the disease in Norway. Moreover, VKM was asked to highlight important risk factors with regard to disease transmission, and how these risk factors might affect choice of management strategy. Finally, VKM was asked to highlight relevant management strategies from North America or elsewhere. VKM appointed a working group consisting of one member of the Panel on Microbial Ecology, one member of the Panel on Biological Hazards, and five external experts, as well as VKM`s secretariat to answer the questions from NEA and NFSA. One member of the Panel on Alien Organisms and Trade in Endangered Species (CITES), one member of the Panel on Animal Health and Welfare, as well as one member of the Panel on Biological Hazards commented on the draft report. The Panel on Biological Hazards assessed and approved the final report. Background Chronic wasting disease (CWD) is a prion disease that affects deer, moose, reindeer, and related species (cervids). Prion diseases are chronic neurodegenerative diseases that occur naturally in humans and ruminants, and are invariably fatal. Some prion diseases, such as classical scrapie in sheep and goats and chronic wasting disease (CWD) in cervids, are contagious, spreading directly between animals or via environmental contamination. In contrast, prion diseases known to affect humans are not known to be contagious. Prions are extraordinary agents consisting of misfolded protein aggregates that are remarkably stable and can remain infectious for years in the environment. Prion proteins are present in most animals, but the misfolding makes them very hard to break down. Consequently, misfolded prion proteins accumulate in the brain and eventually in other tissues, causing damage to those tissues. Until recently, CWD was only known from North America and South Korea. During a routine marking event in April 2016, a female reindeer (Rangifer tarandus) of the Nordfjella wild reindeer herd in Norway exhibited unusual behaviour, and died shortly afterwards. This unusual death was routinely investigated, and the animal was diagnosed with CWD. This was the first time CWD had been diagnosed outside North America and South Korea and the first case of natural CWD in reindeer. In addition, two moose (Alces alces) in Selbu, Norway were diagnosed with CWD in May 2016. Selbu is located approximately 300 km northeast of the Nordfjella mountain range. Currently there is considerable uncertainty regarding the nature of the CWD diagnosed in the two moose. Some of the characteristics of these cases indicate consistency with atypical prion disease, as described in domestic animals, but a final conclusion depends on the results from ongoing investigations. Following the diagnosis in reindeer, Norwegian authorities initiated a screening programme in which hunters were requested to collect tissue and the heads of dead cervids during the 2016 hunting season. Animals that had died from causes other than hunting were also tested for CWD. Since March 2016, 4629 samples of moose, 2550 samples of red deer, 627 samples of roe deer, 860 samples of reindeer, 2494 semi-domesticated reindeer, 163 farmed deer and 104 samples of unidentified species were tested for CWD. Two additional cases of CWD were diagnosed in wild reindeer in the Nordfjella population. Together with a clinical, pathological and epidemiological picture consistent with contagious CWD, as described from North America, this indicated that there is an ongoing outbreak of CWD in the wild reindeer population of the northern part of Nordfjella wild reindeer range. Results An increase in the distribution and prevalence of CWD will increase exposure of other species, including domestic animals and humans, to this infectious agent. There is currently no evidence indicating transmission of CWD to domestic animals or humans, either by direct contact with cervids, cervid meat, or other products from cervids, or through the environment. VKM continues to support the conclusion from phase I concerning food safety of meat from cervids, that the zoonotic risk of CWD (transmission to humans) is very low. Preliminary results from characterisation of the moose cases and the agent involved indicate that important features deviate significantly from those found in the reindeer and in North American cervids, raising uncertainty with regards to the zoonotic potential. Therefore, based on the data currently available, VKM is not able to reach an evidence-based conclusion regarding the food safety of meat from moose and other cervids infected with this potentially new variant of CWD. Whereas direct transmission (animal-to-animal) seems most important in the early phases of a CWD epizootic, the role of indirect transmission (from the environment) increases as the prevalence increases. Once contagious CWD is established, it is very likely that the disease will increase in prevalence within the affected population and spread to contact populations. The rate of increase in prevalence, the resulting impact in a given population, and the efficacy of spread will depend on a range of environmental factors, and the characteristics of the species and population in question. For example, in affected populations of a gregarious species like reindeer, CWD is likely to lead to population decline in the long-term. Experiences from North America indicate that prions aggregate in the environment, making eradication of the disease extremely difficult once it has been allowed to develop and become endemic. It is therefore important that efficient measures are implemented at the earliest opportunity in order to have a realistic chance of eradicating local occurrence of CWD and preventing further spread. Contagious CWD found in a confinable population, such as many wild reindeer herds, should be managed by eradication of the host population, fallowing of the area (> 5 years), and restocking from a healthy population. The report explains that culling of the Nordfjella reindeer herd is a necessary, immediate response to the current situation. However, as part of an adaptive management strategy, this measure should be under active review and may be revised in the event that new cases of CWD are discovered. In contrast, in continuous populations, such as most red deer, moose, and roe deer populations, spatially targeted culling within a defined containment zone should be used to control a CWD outbreak. Confinement of CWD-infected populations should be increased where possible and contact with other populations of cervids restricted, for example by fencing, herding, enhancing natural or man-made obstacles, or decreasing the densities of the relevant cervid populations. Potential “hotspots” for disease transmission (supplementary salt-licks, supplementary feeding sites etc.) should be eliminated in areas with CWD as well as the surrounding areas, and should further be considered for other parts of the country. Precautionary measures should be implemented to prevent anthropogenic spread of the disease. Finally, increasing the national surveillance of CWD in cervids is essential to ensure that there is a comprehensive basis for future evidence-based management. This is required to ensure that cases and spread of disease are identified as soon as possible, as late discovery will limit the chances for successful eradication of CWD in Norway., NO; PDF; vkm@vkm.no

The Norwegian Environment Agency (NEA) asked the Norwegian Scientific Committee for Food Safety (VKM) to assess the risks of negative impacts on biodiversity in Norway from the import and keeping of various species of freshwater plants for aquaria and garden ponds. VKM was asked to assess: (I) species survival under Norwegian conditions, (II) possible impacts on ecosystems and other species, (III) possible risks caused by the introduction of harmful hitchhiker organisms, including pathogens and parasites. In addition, VKM was asked to assess the likelihood of escape or release of the organisms. Possible precautionary measures, such as excluding import from certain areas or excluding certain sub-species or populations, should be included in the report. The assessment adopted a fifty-year perspective and stated for each species whether it can survive below a cut-off temperature of 5° C. This is because current legislation includes an exemption for import permit requirements for species that cannot survive below this cut-off temperature. The final report also included information on whether climate change could particularly affect the outlook for the assessed plant species beyond the specified period of 50 years. Finally, it considered whether the export of these species has any significant negative effects on biodiversity of the exporting country. VKM appointed a working group consisting of members of the Panel on Alien Organisms and Trade in Endangered Species, the VKM Secretariat, an external botanist as well as an external expert on invasive aquatic plants to answer the request to answer the request. The Panel on Alien Organisms and Trade in Endangered Species has reviewed, revised, and finally approved the report prepared by the working group. In order to address the assignment from NEA, all specified taxa were subjected to a preliminary screening followed by a risk assessment. In the preliminary screening, taxa were classified into three categories based on their area of occurrence and climatic preferences: Category 1: taxa naturally occurring in tropical climates, Category 2: taxa naturally occurring in temperate and continental climates, Category 3: taxa occurring naturally in Norway. Taxa classified as Category 1 were individually assessed for their ability to survive below 5°C. Taxa classified as Category 2 were individually risk assessed using a modified two-stage Non-native Species Application-based Risk Analysis (NAPRA) Scheme. Taxa classified as Category 3 were assessed as a group with regard to the risk that these species could transfer genetic material to locally adapted genotypes in native populations. Possible risks caused by the introduction of harmful hitchhiker organisms, including pathogens and parasites, were assessed for all species. None of the plant species in the Terms of Reference (ToR) are reported to have acted as vectors for harmful hitchhiker organisms, including pathogens and parasites, and we therefore assessed that this risk to Norwegian biodiversity to be low. The effects of climate change beyond a 50-year perspective are difficult to predict, but no immediate change in the risks associated with the ToR species were identified as a consequence of climate change beyond a 50-year perspective. Theoretically, there is a possibility that export of some of the evaluated plant species could have a negative impact on the biodiversity of the exporting country, however all the species used for aquarium and garden ponds are taken from cultivated populations and not from wild populations. Responding to the ToR, VKM concludes that none of the Category 1 species can survive below 5° C . VKM concludes that all species in Categories 1 and 3 pose low risks to Norwegian biodiversity, in regard to species survival under Norwegian conditions, possible impacts on ecosystems and other species, and the possible risks caused by the introduction of harmful hitchhiker organisms, including pathogens and parasites. Some species in category 2 do not exhibit any characteristics related to invasiveness in their current areas of occurrence and they have a limited area of occurrence in Europe. VKM concludes that such species pose a low risk to Norwegian biodiversity in regard to points I,II and III above. Further, VKM notes that those species of Category 3 that are on the Norwegian Red List could have a negative impact on Norwegian biodiversity in regard to point II; possible impacts on ecosystems and other species. Red listed species could potentially transfer novel genetic material to locally adapted genotypes. However, the probability of Red listed species of plants escaping from aquariums or garden ponds and subsequently encounter native populations is low, and therefore VKM concludes that these species pose a low risk to Norwegian biodiversity. Finally, species in Category 2 for which a full modified NAPRA risk assessment was conducted, it is concluded that Crassula helmsii and Myriophyllum heterophyllum pose a high risk with, respectively, medium to high confidence, to Norwegian biodiversity with regard to points I, II and III. In addition, Egeria densa, Hydrilla verticillata, Lagarosiphon major, Lemna gibba, Myriophyllum aquaticum, Najas minor, andTrapa natans pose a moderate risk, with medium to high confidence depending on the species, to Norwegian biodiversity, with regard to points I, II and III . All other species are considered to pose a low risk, with low to high confidence depending on the species, to Norwegian biodiversity with regard to points I, II and III above., NO; PDF; vkm@vkm.no

The Norwegian Scientific Committee for Food Safety (VKM) was requested by the Norwegian Environment Agency in November 2015 to develop a knowledge base for assessment of the environmental risks related to the use of genetically modified (GM) virus vaccine vectors for vaccination of domesticated animals. The Agency requested that the task be conducted in the form of a desk study with the following mandate: (1) to provide a short description of GM virus vectors in use in veterinary vaccines; (2) summarize available information relevant to environmental risk assessment (ERA) of GM veterinary virus vaccines; and (3) identify environmental risk factors and knowledge gaps of relevance to ERA of GM virus vaccines within the Norwegian context. This report provides background for future environmental risk assessment of veterinary medicinal products containing or consisting of GMO for use in Norway. VKM has appointed a working group consisting of members of the Panel on Microbial Ecology and the VKM secretariat to answer the request. The VKM Panel has reviewed and revised the draft prepared by the working group and finally approved the opinion. This Report contains the findings of a desk study of current virus vectors used in GM virus vectored vaccines of domesticated livestock. A survey of the published literature for current knowledge in the area was undertaken with the aim of providing information relevant to the ERA of veterinary GM virus vectors (GM-VV). In identifying potential risk factors associated with vaccination of domesticated animals using GM-VV, focus was on the Norwegian environment, but relevant parallels were drawn from other European countries. The European Commission directive 2001/18, that regulates the deliberate release of genetically modified organisms into the environment, the European Union Regulation for approval of medicinal products (726/2004/EU), and other relevant guidelines from the European Medicines Agency (EMA) on ERA of GMOs and live recombinant vector vaccines for veterinary use served as reference documents. Virus vaccine vectors, according to the Directive 2001/18/EC, are genetically modified if they were produced using techniques of recombinant gene technology. The environment, according to the Directive, constitutes all components of the ecosystem (excluding the vaccinated animals) that could be at risk of the deliberate use (or release) of veterinary GM-VV. Enumeration of GM virus vectors was limited to those applied in domesticated livestock vaccination, but evaluation of relevant environmental risk factors of the GM vaccine vectors was extended to other animals, e.g. wild animals as well as to humans and microorganisms, as these are the at-risk non-target components of the environment. The Report, however, did not dwell extensively on risks to human health and non-domesticated animals. Nonetheless, occupational and non-occupational risk routes of handling GM-VV were briefly discussed, and parallels were drawn from the use of GM-VV to control rabies in wildlife. The DNA virus genera of poxvirus, herpesvirus and adenovirus are the most commonly employed in GM vaccine vectors for domesticated animal vaccination. Most virus vector strains are specific to the animal species, but some have been used across species. For example, canarypox virus and human adenovirus serotype 5 (HAd5) vectors derived from the genera of pox- and adenoviruses respectively. Canarypox virus has been used to vaccinate cat, horse, ferret, dog, sheep and rabbit; HAd5 has been used in field trial for vaccination of dog, fox, pig and cattle. Target veterinary diseases for vaccination are those for which there currently exist no efficient therapeutic and prophylactic measures. Animal health is the main driver that determines the choice of disease against which GM-VVs are produced, the most successful application of GM-VVs in the vaccination of domesticated animals being the control of avian diseases. Hazards and potential risk to the environment are linked to shedding, survival and potential dissemination of the GM-VV. For example, as a consequence of delivery mechanism, GM-VVs have been delivered directly into the environment, in the case of the rabies GM vaccine bait used to control rabies in several parts of Europe. Although this is not applicable to the Norwegian mainland, relevant parallels can be drawn from these experiences. Studies on the GM rabies vaccines currently in use show that they are stable for few months in the environment, but residual pathogenicity cannot be ruled out entirely. In addition, successive selections from the original strain may produce hazardous and uncontrolled results, and variants may remain pathogenic both in target and non-target species. Compared to other geographic regions, the Norwegian physical and veterinary environments are unique in many ways, especially in relation to climate, diversity of both macro- and microorganisms, farm and animal handling practices (e.g. animal species and population, confinement, distances of animal transportation, manure and carcass disposal, and government regulations) –factors that are relevant to ERA of GM-VV. Finally, some knowledge gaps and the limitations these could portend to ERA of GM-VV in Norway were highlighted in the Report in the following context: GM-VV are currently not used in livestock vaccination in Norway. Thus, information on the ERA of GM-VV within the Norwegian context could not be derived; Even in countries with experience of the use of GM-VV, ERA-relevant important information such as post-release data, is not publicly available; Climate change will impact some factors relevant for ERA of GM-VV, especially within the Norwegian context. The extent of such impact is currently unknown., NO; PDF; vkm@vkm.no

In 2015, The Norwegian Environment Agency requested the Norwegian Scientific Committee for Food Safety (VKM) to provide a scientific assessment of the information requirements laid down in the declaration form for the Regulation on microbial products and its guidelines, if these are sufficient to conduct a health and environmental risk assessment of the use of microbial cleaning products in Norway. VKM appointed a working group consisting of members of the Panel on Microbial Ecology. The Panel on Microbial Ecology has reviewed and revised the draft prepared by the working group, and the assessment has been adopted. Based on scientific assessment of the information requirements laid down in the declaration form of the Regulation on microbial products, the VKM Panel recommends that the information requirements in their current form should be revised to facilitate health and environmental risk assessment of the use of microbial cleaning products in Norway. There seems to be a general lack of accuracy when it comes to specification of the microbial content and concentrations (metabolically active vs. inactivated or dead cells) in the product. Without proper taxonomic classification, no meaningful risk assessment is feasible. The taxonomic affiliation of the organisms present in the product should be specified to at least species, preferably strain level. The declaration should in our opinion not necessarily rely on specific methods, as long as the methods described are scientifically adequate. However, the identification should be based on new molecular methods, for e.g. the potential role of the microorganism in the product acting as a pathogen or an allergen, its association to intestinal dysbiosis or genes coding for antibiotic resistance can be identified. Rather than specifying a list of specific antibiotics one should employ generic classes of antibiotics as stipulated in the Nordic Ecolabelling guidelines. The Panel recommends a multiphasic approach to future assessments, as this allows for the implementation of current and most effective methods as they are developed and verified. There seems to be lack of emphasis on environmental impacts, especially on the potential for persistence and spread in the environment (terrestrial or aquatic), the potential for pathogenic effects on domestic or wild vertebrates, arthropods or plants. Furthermore, there is little emphasis on the effects with increased use and accumulation, persistence and spread, both indoor, in terrestrial and aquatic environments and on long-term effects on the microbial community. The state (living, dead, inactivated) and form (vegetative, viable spores (bacteria and fungi) or cysts (protozoans)) of the microorganism present should be specified. If the product contains organisms that form endospores, spores or cysts, procedures for activation of the spores or cysts and for further cultivation should be described. This makes it possible to test whether the spores or cysts are not viable. The method employed for eventual inactivation or sterilization such as heat or chemical treatment, radiation, or dose, and the exposure time and concentration of the micro- organism should be described. Information on how the product has been tested to ensure that it does not contain live microorganisms is also required. The declaration should provide information about the procedures and quality controls securing a product without contaminations, pathogens, or known relevant virulence or resistance factors that may increase health or environmental risks. The safety reassurances provided by producers of microbial cleaning products, should also cover properties related to allergenicity, sensitization, plant pathogenicity and environmental impacts. How the microbes in the product and their pathogenic properties develop with time through and after shelf life should also be described. In our opinion a declaration should include information about intended use and instructions for use, if specific precautions (personal protection, waste, containers etc.) need to be taken. Furthermore, information relating to user groups should be provided; for example if the product is suitable for use in certain settings and environments such as healthcare institutions, food facilities, and areas with vulnerable people (immunocompromised, infants, elderly, pregnant women etc.) or production animals. The term “Environmental Damage” is not sufficiently defined. What kind of shift in the microbial community and local community can be expected in the receiving environment, especially if exposure is chronic and frequent? The document focuses only on the introduction of foreign genes into the ecosystem. The environment can also be permanently altered (or damaged) if the introduction of the new organisms results in the extinction of the naturally existing closely related species. In addition, metabolic products that might affect resident microbial communities could be valuable information. A re-evaluation of current national and international regulatory and policy frameworks may be necessary. This can include an evaluation of the most appropriate instruments (e.g. product declaration forms, regulations, standards, codes of practice, etc.) to use for strengthening these frameworks to mitigate risks to human health and the environment., NO; PDF; vkm@vkm.no

Carnation FLO-40685-2 is a genetically modified variety of Dianthus caryophyllus L. used as a decorative plant species. The purple colour of the flowers results from expression of the two introduced genes dfr and f3’5’h, encoding the enzymes dihydroflavonol 4-reductase (DFR) and flavonoid 3’,5’-hydroxylase (F3’5’H). Together with endogenous enzymes involved in the anthocyanin biosynthesis pathway, DFR and F3’5’H enables the production of the anthocyanidins (plant pigments) delphinidin and cyanidin in the flower petals. Anthocyanidins and their sugar derivatives, anthocyanins, make up a large group of natural colours and are accepted food additives (E 163). The colours of most flowers, berries and fruits consist of a combination of anthocyanidins and anthocyanins. Carnation line FLO-40685-2 also contains a mutated herbicide tolerance gene from Nicotiana tabacum, coding for an acetolactate synthase (ALS) variant protein, used to facilitate the selection of GM plantlets during the genetic transformation process. There are four transgenic inserts in the genome of FLO-40685-2, at four different loci. Only one of the loci includes the intended full length T-DNA sequence. Flanking sequences indicate no disruption of endogenous genes by the inserts. In silico analyses show no significant homologies between the DFR, F3’5’H an ALS proteins and known toxins or IgE-bound allergens. Expression of any new open reading frame(s) (ORF) with significant similarity to known toxin(s) or allergen(s) is highly unlikely. No observed changes in the introduced trait, i.e. the particular flower colour, indicative of instability, have been reported during numerous generations of vegetatively propagated plants since 1997. Considering that carnation FLO-40685-2 is not intended for cultivation or use as food or feed, the VKM GMO Panel considers the comparative analysis of the anthocyanidins delphinidin, cyanidin, petunidin and pelargonidin in the flower petals sufficient for the risk assessment. The reported morphological differences between FLO-40685-2 and the conventional counterpart (parental variety) Cream Cinderella do not raise safety concerns. Based on current knowledge and the scope of the application, the VKM GMO Panel concludes that the DFR, F3’5’H and ALS proteins and anthocyanidin pigments are unlikely to increase a potential health risk related to an accidental intake or other exposure routes to carnation FLO-40685-2 compared to the conventional counterpart or other non-GM carnations. Likewise, the VKM GMO Panel concludes that carnation FLO-40685-2, based on current knowledge and the intended use as cut ornamental flowers, does not represent an environmental risk in Norway., NO: PDF; vkm@vkm.no

The current information requirements regarding microorganisms employed in the clean-up of contaminated soil and water (bioremediation) is not sufficient to conduct health and environmental risk assessments of such products. That is the main conclusion in a report conducted by the Norwegian Scientific Committee for Food Safety (VKM). The Norwegian Environment Agency has requested the report. Bioremediation involves the use of organisms, primarily microorganisms, to transform or break down toxic compounds to less toxic alternatives. The degradation process is enhanced by administering additional microorganisms, so-called bioaugmentering. The declaration form According to the Norwegian regulation on the declaration and labelling of microorganisms, importers, manufacturers as well as distributors of microbiological products in Norway are required to label and declare products in the Product registry employing a separate declaration form. The Norwegian Environment Agency uses the information obtained to assess the health and environmental risks of such products should they be applied. Limited knowledge on bioremediation Based on current knowledge, VKM is of the opinion that bioaugmentering as a remediation process seems to be relatively cost effective and easy to undertake. The method poses less stress to the environment than conventional methods used to clean-up polluted ground. There is, however, the potential risk that the introduced microorganisms can affect both the existing microbial community and the ecosystem as a whole. Limited information requirement VKM concludes that today's demand on the information requirements in the declaration form is not sufficient to be able to carry out a health and environmental risk assessment. More precise descriptions of products are required to be able to conduct meaningful risk assessments, among others. VKM also points out that today's requirements lacks emphasis on the environmental impact posed by foreign organisms. In particular, the potential spread of microorganisms in terrestrial or aquatic environments and the subsequent long-term effects. Additionally, today's requirements do not emphasize the potential of foreign organisms to inflict disease on animals and plants. About the assignment The Norwegian Environment Agency requested the Norwegian Scientific Committee of Food Safety (VKM) to evaluate whether the current requirements for information regarding microorganisms used to clean-up contaminated soil (bioremediation measures) is sufficient to conduct health and environmental risk assessment. If the current requirements are insufficient, VKM was asked to provide what requirements should apply. In addition, VKM was requested to provide an overview of the different methods of bioremediation measures and microorganisms currently used. VKMs panel for microbial ecology has been responsible for this work., NO; PDF; vkm@vkm.no

International wildlife trade is estimated to be worth billions of dollars annually and to include hundreds of millions of plant and animal specimens. The commerce is diverse, ranging from live animals and plants, to parts of organisms and derivatives thereof utilized for food, clothing, medicine, building materials, decorative items etc. International trade in endangered species is regulated through the CITES Convention (The Convention on International Trade in Endangered Species of Wild Fauna and Flora). The aim of the Convention is to prevent trade across borders leading to over-exploitation of species. Currently more than 35,000 species are protected at various levels by CITES (Appendices I, II, III). Currently 182 countries (Parties) have joined and are thereby bound by the Convention. The parties have to adopt their own domestic legislation to ensure that CITES is implemented at the national level. They are obligated to designate one or more Management Authorities to administrate a licensing system for imports and exports, and one or more Scientific Authorities to advise them on possible impacts of trade on species survival. The supreme decision making body of CITES is the Conference of the Parties (CoP), where all the Parties are represented. The Parties have agreed upon a resolution with a set of criteria for listing of species in the CITES Appendices, the Resolution Conf. 9.24. All amendments to Appendix I and II (i.e. transfer of already listed species between Appendix I and II, inclusion of new species, or removal of species listed in Appendix II) have to be done in accordance to the latest revision of the Resolution: Res. Conf. 9.24 (Rev. CoP16). All Parties are eligible to propose amendments to the Appendices in advance of the CoP. The Norwegian Environment Agency has assigned VKM to review a list of proposals for amendments to Appendix I and II submitted ahead of the seventeenth meeting of the CoP (CoP17) that will be held in the autumn of 2016. The list of proposals includes six different organismal groups: mammals, birds, reptiles, amphibians, terrestrial invertebrates and plants. VKM has put forward a project group comprising participants from the panel on Alien organisms and trade in endangered species (CITES), VKM’s secretariat as well as external experts. The project group has reviewed the information given in each proposal and searched for additional data in order to assess the impact of legal and illegal trade. VKM has summarized the material on each species in fact-sheets. The fact sheets will constitute the scientific basis for a national public hearing of the listing proposals prior to the CoP17. If accepted, the amendments will be effectuated three months after the meeting., NO; PDF; vkm@vkm.no

Carnation SHD-27531-4 is a genetically modified variety of Dianthus caryophyllus L. used as a decorative plant species. The red-purple colour of the flowers results from expression of the two newly introduced genes dfr and f3’5’h, encoding the enzymes dihydroflavonol 4-reductase (DFR) and flavonoid 3’,5’-hydroxylase (F3’5’H). The two enzymes enable the production of the pigments delphinidin and cyanidin (anthocyanidins) in the flower petals. Anthocyanidins and their sugar derivatives, anthocyanins, make up a large group of natural colours and are accepted food additives (E 163). The colours of most flowers, berries and fruits consist of a combination of anthocyanidins and anthocyanins. Carnation line SHD-27531-4 also contains a mutated herbicide tolerance gene from Nicotiana tabacum, coding for an acetolactate synthase (ALS) variant protein, used to facilitate the selection of GM plantlets during the genetic transformation process. Southern blot analysis and sequencing indicate only a single copy of the intended T-DNA insert in the SHD-27531-4 genome. Flanking sequences show no disruption of endogenous genes. In silico analyses show no significant homologies between the DFR, F3’5’H an ALS proteins and known toxins and IgE-bound allergens. No observed changes in the introduced trait, i.e. the particular flower colour, indicative of instability, have been reported during several generations of vegetatively propagated plants. Considering that carnation SHD-27531-4 is not intended for cultivation or use as food or feed, the VKM GMO Panel considers the comparative analysis of the anthocyanidins delphinidin, cyanidin, petunidin and pelargonidin in the flower petals sufficient for the risk assessment. The reported morphological differences between SHD-27531-4 and the parent cultivar do not raise safety concerns. Based on current knowledge and the scope of the application, the VKM GMO Panel concludes that the DFR, F3’5’H and ALS proteins and anthocyanidin pigments are unlikely to increase a potential health risk related to an accidental intake or other exposure routes to carnation SHD-27531-4 compared to the conventional counterpart or other non-GM carnations. Likewise, the VKM GMO Panel concludes that carnation SHD-27531-4, based on current knowledge and the intended use as cut ornamental flowers, does not represent an environmental risk in Norway., NO; PDF; vkm@vkm.no

The Norwegian Scientific Committee for Food Safety (VKM) has been asked by the Norwegian Environment Agency to undertake an assessment of the risks of negative impacts on biodiversity in Norway stemming from the import of terrestrial scorpions, tarantulas, mantids, and stick insects for private use. The committee was asked to assess (1) species survivability under Norwegian conditions, (2) possible impacts of private import on ecosystems and other species, (3) possible risks arising from the introduction of accompanying organisms such as pathogens and parasites, and (4) the likelihood of escape or release of the imported organisms and precautionary measures that could prevent this from happening. The committee was asked to adopt a fifty year perspective in this assessment. Furthermore, any known negative effects on biodiversity of the exporting country should be stated in the report. These factors should, however, not be included as a part of the actual risk assessment. VKM appointed a working group consisting of members of the Panel on Alien Organisms and Trade in Endangered Species and the VKM Secretariat to answer the request. The Panel on Alien organisms and Trade in Endangered Species has reviewed, revised and finally approved the report prepared by the working group. VKM adopted a two-stage procedure, including an initial screening of all species included in the Terms of Reference and a risk assessment of the species judged to have a potential for establishment in Norway. The initial screening identified taxa with a potential for establishing populations in Norway based on the similarity between climatic conditions in Norway and the organisms current distribution. In cases where a taxon’s likelihood of establishment was assessed as being very unlikely, no further assessments were conducted. In cases where the climate conditions of the taxon’s current habitat resemble those of Norway now or in a 50-year perspective, a risk assessment was carried out for that taxon in stage two of the procedure. Where very limited or no background information existed, taxa were classified as “lack of information” and could not be assessed further. The working group screened 6600 species for establishment potential under Norwegian climatic conditions; 6489 species were deemed very unlikely to establish populations and were not assessed further. Sixty-one species were classified as “lack of information”. Fifty-one species were assessed as having potential for establishing populations in Norway, and were risk assessed in stage two of the procedure. For the risk assessment, the working group used an adaptation of the Great Britain Non-Native Species Secretariat`s risk assessment template; the original template was deemed as it cover all aspects of the Terms of Reference. The stage two assessment includes judging the probability of entry, a further and more detailed evaluation of the probability of establishment, judging the probability of spread, an assessment of environmental consequences or impact, and finally an overall risk rating for the taxon in question. VKM concludes that there is a potential for establishment in Norway in a 50-year perspective, for 20 species of tarantulas, 10 mantids and 20 phasmids (but no scorpions). Only two mantid species, Mantis religiosa and Orthodera novaezealandiae, are assessed as having a moderate risk of causing negative impacts on Norwegian biodiversity and ecosystems. If they can enter the country, these species is likely to be able to establish viable populations in Norway in a 50 year perspective. M. religiosa devours large numbers of prey and is currently spreading in Europe and in North America; however, there are no reports of significant impacts of this species on native biodiversity., NO; PDF; vkm@vkm.no

Genetically modified LLcotton25 from Bayer CropScience expresses the bar gene from Streptomyces hygroscopicus ATCC21705 encoding the phosphinothricin-acetyl–transferase (PAT) enzyme, which confers tolerance to the active herbicide glufosinate-ammonium. Updated bioinformatics analyses of the inserted DNA and flanking sequences in LLCotton25 have not indicated potential production of putatively harmful toxins or allergens caused by the genetic modification. Genomic stability of the functional insert and consistent expression of the bar gene have been shown over several generations of LLCotton25. Data from field trials indicate that with the exception of the newly introduced trait, LLCotton25 is compositionally, phenotypically and agronomically equivalent to its conventional counterpart Coker 312 and other cotton cultivars. 33-day nutritional assessment trial with broilers has not revealed adverse effects of cottonseed meal from LLCotton25. Toxicity testing of the PAT protein in a repeated-dose dietary exposure test with rats did not indicate adverse effects. The PAT protein produced in LLCotton25 does not show amino acid sequence resemblance to known toxins or IgEdependent allergens, nor has it been reported to cause IgE-mediated allergic reactions. It is therefore unlikely that the PAT protein will cause toxic or IgE-mediated allergic reactions to food or feed containing LLCotton25 compared to conventional cotton cultivars. Cotton is not cultivated in Norway, and there are no cross-compatible wild or weedy relatives of cotton in Europe. Based on current knowledge and with the exception of the introduced traits, the VKM GMO Panel concludes that LLCotton25 is nutritionally, compositionally, phenotypically and agronomically equivalent to and as safe as its conventional counterpart and other cotton cultivars. Considering the intended uses, which exclude cultivation, the VKM GMO Panel concludes that LLCotton25 does not represent an environmental risk in Norway., NO; PDF; vkm@vkm.no

Genetically modified cotton GHB614 from Bayer CropScience expresses a modified epsps gene (2mepsps) gene from maize encoding the enzyme 5-enolpyruvylshikimate 3-phosphate synthase (2mEPSPS), which confers tolerance to the herbicide glyphosate. Updated bioinformatics analyses of the inserted DNA and flanking sequences in GHB614 have not indicated potential production of putatively harmful toxins or allergens caused by the genetic modification. Genomic stability of the functional insert and consistent expression of the 2mepsps gene has been shown over several generations of cotton GHB614. Field trials indicate that with the exception of the introduced trait, cotton GHB614 is compositionally, phenotypically and agronomically equivalent to its conventional counterpart Coker 312 and other cotton cultivars. A 42-day nutritional assessment trial with broilers did not reveal adverse effects of cottonseed meal from GHB614. The 2mEPSPS protein produced in GHB614 does not show amino acid sequence resemblance to known toxins or IgE-dependent allergens, nor has it been reported to cause IgE-mediated allergic reactions. It is therefore unlikely that the 2mEPSPS protein will cause toxic or IgE-mediated allergic reactions to food or feed containing cotton GHB614 compared to conventional cotton cultivars. Cotton is not cultivated in Norway, and there are no cross-compatible wild or weedy relatives of cotton in Europe. Based on current knowledge and with the exception of the introduced trait, the VKM GMO Panel concludes that cotton GHB614 is nutritionally, compositionally, phenotypically and agronomically equivalent to and as safe as its conventional counterpart and other cotton cultivars. Considering the intended uses, which exclude cultivation, the VKM GMO Panel concludes that GHB614 does not represent an environmental risk in Norway., NO; PDF; vkm@vkm.no

Genetically modified cotton 281-24-236 x 3006-210-23 (MXB-13) from Dow AgroSciences was produced by conventional crossing of the single-event GM-cotton cultivars 281-24-236, which expresses the cry1F and pat genes, and 3006-210-23, which expresses the cry1Ac and pat genes. The resulting stacked event cotton MXB-13 expresses all three proteins: Cry1Ac, Cry1F and the phosphinothricin-acetyl–transferase (PAT) enzyme. The Cry-proteins confer resistance against specific lepidopteran pests and the PAT-enzyme renders cotton MXB-13 tolerant to application of the herbicide glufosinate-ammonium. Updated bioinformatics analyses of the inserted DNA and flanking sequences in cotton MXB-13 have not indicated potential production of putative harmful toxins or allergens caused by the genetic modification. Genomic stability of the functional inserts and consistent expression of the cry1Ac, cry1F and pat genes have been shown over several generations of cotton MXB-13. Data from several field trials performed in the USA indicate that with the exception of the introduced traits, cotton MXB-13 is compositionally, phenotypically and agronomically equivalent to its conventional counterparts and other cotton cultivars. A 90-day sub-chronic oral toxicity study with rats and a 42-day nutritional assessment trial with broilers have not revealed adverse effects of cottonseed meal from cotton MXB-13 compared to meal from the conventional counterpart PSC355 and other cotton cultivars. Toxicity testing of the Cry1Ac, Cry1F and PAT proteins in repeated-dose dietary exposures with mice and rats did not indicate adverse effects. The Cry1Ac, Cry1F and PAT proteins produced in cotton MXB-13 do not show amino acid sequence resemblance to known toxins or IgE-dependent allergens, nor have they been reported to cause IgE-mediated allergic reactions. It is therefore unlikely that the Cry1Ac, Cry1F and PAT proteins will cause toxic or IgE-mediated allergic reactions to food or feed containing cotton MXB-13 compared to conventional cotton cultivars. Cotton is not cultivated in Norway, and there are no cross-compatible wild or weedy relatives of cotton in Europe. Based on current knowledge and with the exception of the introduced traits, the VKM GMO Panel concludes that cotton MXB-13 is nutritionally, compositionally, phenotypically and agronomically equivalent to and as safe as its conventional counterparts and other cotton cultivars. Considering the intended uses, which exclude cultivation, the VKM GMO Panel concludes that cotton MXB-13 does not represent an environmental risk in Norway., NO; PDF; vkm@vkm.no