Environmental risk assessment of GE plants under low-exposure conditions

The requirement for environmental risk assessment (ERA) of genetically engineered (GE) plants prior to large scale or commercial introduction into the environment is well established in national laws and regulations, as well as in international agreements. Since the first introductions of GE plants in commercial agriculture in the 1990s, a nearly universal paradigm has emerged for conducting these assessments based on a few guiding principles. These include the concept of case-by-case assessment, the use of comparative assessments, and a focus of the ERA on characteristics of the plant, the introduced trait, and the receiving environment as well as the intended use. In practice, however, ERAs for GE plants have frequently focused on achieving highly detailed characterizations of potential hazards at the expense of consideration of the relevant levels of exposure. This emphasis on exhaustive hazard characterization can lead to great difficulties when applied to ERA for GE plants under low-exposure conditions. This paper presents some relevant considerations for conducting an ERA for a GE plant in a low-exposure scenario in the context of the generalized ERA paradigm, building on discussions and case studies presented during a session at ISBGMO 12

Estimating the burden of disease attributable to low fruit and vegetable intake in South Africa in 2000

Objectives. To estimate the burden of disease attributed to low fruit and vegetable intake by sex and age group in South Africa for the year 2000. Design. The analysis follows the World Health Organization comparative risk assessment (CRA) methodology. Populationattributable fractions were calculated from South African prevalence data from dietary surveys and applied to the revised South African burden of disease estimates for 2000. A theoretical maximum distribution of 600 g per day for fruit and vegetable intake was chosen. Monte Carlo simulationmodelling techniques were used for uncertainty analysis. Setting. South Africa. Subjects. Adults ≥ 15 years. Outcome measures. Mortality and disability-adjusted life years (DALYs), from ischaemic heart disease, ischaemic stroke, lung cancer, gastric cancer, colorectal cancer and oesophageal cancer. Results. Low fruit and vegetable intake accounted for 3.2% of total deaths and 1.1% of the 16.2 million attributable DALYs. For both males and females the largest proportion of total years of healthy life lost attributed to low fruit and vegetable intake was for ischaemic heart disease (60.6% and 52.2%, respectively). Ischaemic stroke accounted for 17.8% of attributable DALYs for males and 32.7% for females. For the related cancers, the leading attributable DALYs for men and women were oesophageal cancer (9.8% and 7.0%, respectively) and lung cancer (7.8% and 4.7%, respectively). Conclusions. A high intake of fruit and vegetables can make a significant contribution to decreasing mortality from certain diseases. The challenge lies in creating the environment that facilitates changes in dietary habits such as the increased intake of fruit and vegetables. South African Medical Journal Vol. 97 (8) Part 2 2007: pp. 717-72

Estimating the burden of disease attributable to childhood and maternal undernutrition in South Africa in 2000

Objectives. To estimate the disease burden attributable to being underweight as an indicator of undernutrition in children under 5 years of age and in pregnant women for the year 2000. Design. World Health Organization comparative risk assessment (CRA) methodology was followed. The 1999 National Food Consumption Survey prevalence of underweight classified in three low weight-for-age categories was compared with standard growth charts to estimate population-attributable fractions for mortality and morbidity outcomes, based on increased risk for each category and applied to revised burden of disease estimates for South Africa in 2000. Maternal underweight, leading to an increased risk of intra-uterine growth retardation and further risk of low birth weight (LBW), was also assessed using the approach adopted by the global assessment. Monte Carlo simulation-modelling techniques were used for the uncertainty analysis. Setting. South Africa. Subjects. Children under 5 years of age and pregnant women. Outcome measures. Mortality and disability-adjusted life years (DALYs) from protein- energy malnutrition and a fraction of those from diarrhoeal disease, pneumonia, malaria, other non- HIV/AIDS infectious and parasitic conditions in children aged 0 - 4 years, and LBW. Results. Among children under 5 years, 11.8% were underweight. In the same age group, 11 808 deaths (95% uncertainty interval 11 100 - 12 642) or 12.3% (95% uncertainty interval 11.5 - 13.1%) were attributable to being underweight. Protein-energy malnutrition contributed 44.7% and diarrhoeal disease 29.6% of the total attributable burden. Childhood and maternal underweight accounted for 2.7% (95% uncertainty interval 2.6 - 2.9%) of all DALYs in South Africa in 2000 and 10.8% (95% uncertainty interval 10.2 - 11.5%) of DALYs in children under 5. Conclusions. The study shows that reduction of the occurrence of underweight would have a substantial impact on child mortality, and also highlights the need to monitor this important indicator of child health. South African Medical Journal Vol. 97 (8) Part 2 2007: pp. 733-73

Estimating the burden of disease attributable to excess body weight in South Africa in 2000

Objective. To estimate the burden of disease attributable to excess body weight using the body mass index (BMI), by age and sex, in South Africa in 2000. Design. World Health Organization comparative risk assessment (CRA) methodology was followed. Re-analysis of the 1998 South Africa Demographic and Health Survey data provided mean BMI estimates by age and sex. Populationattributable fractions were calculated and applied to revised burden of disease estimates. Monte Carlo simulation-modelling techniques were used for the uncertainty analysis. Setting. South Africa. Subjects. Adults 30 years of age. Outcome measures. Deaths and disability-adjusted life years (DALYs) from ischaemic heart disease, ischaemic stroke, hypertensive disease, osteoarthritis, type 2 diabetes mellitus, and selected cancers. Results. Overall, 87% of type 2 diabetes, 68% of hypertensive disease, 61% of endometrial cancer, 45% of ischaemic stroke, 38% of ischaemic heart disease, 31% of kidney cancer, 24% of osteoarthritis, 17% of colon cancer, and 13% of postmenopausal breast cancer were attributable to a BMI 21 kg/m2. Excess body weight is estimated to have caused 36 504 deaths (95% uncertainty interval 31 018 - 38 637) or 7% (95% uncertainty interval 6.0 - 7.4%) of all deaths in 2000, and 462 338 DALYs (95% uncertainty interval 396 512 - 478 847) or 2.9% of all DALYs (95% uncertainty interval 2.4 - 3.0%). The burden in females was approximately double that in males. Conclusions. This study shows the importance of recognising excess body weight as a major risk to health, particularly among females, highlighting the need to develop, implement and evaluate comprehensive interventions to achieve lasting change in the determinants and impact of excess body weight

Melons - Health Hazard through Contamination with Pathogenic Bacteria

Melons can come into contact with bacteria, viruses or parasites at any stage of the food supply chain from production and transport to preparation in private households. Pathogens can be transferred from the skin to the flesh of the fruit when the melons are cut. At warm temperatures, in particular salmonella, listeria and EHEC can easily multiply on the flesh which is low in acidity. Accordingly, outbreaks of illness have in the past been triggered by the consumption of melons contaminated with these pathogens. In order to avoid illness, the rules of personal and kitchen hygiene should be strictly adhered to during the preparation of melons. For example, it is important to ensure sufficiently large and clean working areas, clean hands and to use thoroughly cleaned knives and chopping boards. These rules of hygiene are all the more important in view of the fact that a small infection dose suffices to cause an infection from pathogens such as campylobacter, EHEC and norovirus. In addition, the Federal Institute for Risk Assessment (BfR) recommends to food retail stores, catering businesses and community institutions only to cut up small quantities of melons which can be sold to customers within about two hours. Consumers should eat cut up melons quickly or, alternatively, refrigerate them as soon as possible. Pieces of melons which have been kept unrefrigerated for several hours or exposed to high temperatures (e.g. through sunlight), should, as a precaution, be disposed of. To protect themselves against infections, especially sensitive persons should, to be on the safe side, refrain from eating cut melons which have been stored at room temperatures for several hours. Risk groups include pregnant women, small children as well as elderly and sick persons. These groups should think carefully before eating cut-up melons, if they do not know whether the fruit has been kept unrefrigerated for lengthy periods of time

No health risk from traces of nicotine in chicken eggs

Nicotine is a strong toxin and the main alkaloid of the tobacco plant. This substance is found in tobacco smoke and is used as a medicinal component in nicotine gum and nicotine patches to help people give up smoking. Low levels of nicotine occur naturally in nightshade plants like potatoes, tomatoes and aubergines but also in other plants like cauliflower. Nico-tine can be produced synthetically, too. In conjunction with nicotine traces in chicken eggs, the Federal Institute for Risk Assessment (BfR) has assessed the potential health risk to consumers from the consumption of eggs contaminated with nicotine. As the Institute does not have any concrete figures on nicotine levels in eggs, various exposure scenarios were calculated. BfR compared the estimated exposure to nicotine intake from foods like potatoes, which are consumed regularly, and passive smoking. The result: the temporary consumption of eggs with nicotine levels in the range of 3 to 300 μg nicotine per kilogram whole egg does not constitute a health risk for consumers. In principle, however, eggs may not contain any nicotine

Joint development of a new Greenhouse Agricultural Operator Exposure Model for hand-held application

A new greenhouse model for operator exposure has been developed for the purpose of risk assessment of plant protection products in the EU. It is based on exposure data from the Southern European Greenhouse project that were statistically reanalysed and modelled according to procedures already established for the outdoor AOEM project. The model is suitable for operator exposure during mixing/loading and spraying in low crops or high crops using hand-held equipment with stationary mix tanks. Based on a statistical analysis of the data a joint approach was chosen for the tank mixing/loading: data from the outdoor AOEM and the greenhouse database were combined resulting in a tank mixing/loading model valid for outdoor and greenhouse uses. For the application task in low crops and high crops a normal scenario and a dense scenario (frequent contact with treated crop) are available. Exposure mitigation for the use of work wear, gloves and impermeable clothing (for dense application scenario only) is integrated in the model and can be selected for a stepwise risk assessment. Assuming that conditions and practices are similar across Europe the new greenhouse model can be applied by all MS as a harmonised approach for the evaluation and the authorisation of plant protection products

BfR recommends provisional daily upper intake level and a guidance value for morphine in poppy seeds

Poppy seeds are the mature seeds of opium poppy (Papaver somniferum L.). Because of their content of fatty oil and protein, they are used in the food sector in the manufacturing of bakery products and edible oil. Opium and its alkaloids can be obtained from the same plants from whose capsules the seeds are harvested. Opium is the name given to the dried milky sap which is obtained from the immature capsules. The most well known and most important opium alkaloid is morphine. Poppy seeds may also contain traces of alkaloids. In April 2005 BfR issued a warning about damage to health from poppy seeds in a press release. A mother had used an old home remedy and given her six-week-old baby strained milk from poppy seed to treat its sleep problems. The child was rushed to hospital with respiratory disorders and impaired consciousness and treated there on suspicion of opiate intoxication. High levels of the alkaloids, morphine and codeine, were detected in its urine. In this context BfR pointed out that poppy seeds may contain varying amounts of morphine and codeine because of fluctuations in quality. Against this backdrop and following reports of the misuse of edible poppy seeds to produce drugs, BfR undertook a risk assessment of the occurrence of morphine in edible poppy seeds and issued an expert opinion on possible health risks for consumers. It is clear that highly contaminated poppy seed batches are dangerous and not marketable. When, however, is the consumption of poppy seeds with lower morphine concentrations problematic in terms of health from the precautionary angle? In order to give official food control authorities an instrument to answer this question, BfR has established a "provisional daily upper intake level" for morphine. It is 6.3 microgram morphine per kilogram body weight per day. It indicates the morphine intake which should not be exceeded during

Initial evaluation of the assessment of levels of glycidol fatty acid esters de-tected in refined vegetable fats

The Chemical and Veterinary Test Agency (CVUA) Stuttgart has detected glycidol fatty acid esters in refined vegetable fats on a palm oil base. The analytical methods currently available do not, however, permit the determination, merely the estimation of the exact levels. Fur-thermore, we do not know what levels of glycidol are released from the glycidol fatty acid esters during digestion in humans. Based on findings from animal experiments, glycidol is classified as probably carcinogenic to humans. Because of this major hazard potential and because refined edible fats are used in products like margarine and in infant formula, too, the Federal Institute for Risk Assessment (BfR) takes the findings of CVUA Stuttgart seriously and presents its initial evaluation of the as-sessment whether the detected ester-bound glycidol could constitute a threat to health. This evaluation is based on the worst case scenario that glycidol is released fully during digestion from the fatty acid esters and is then available in the organism. As the exact levels of glycidol fatty acid esters could not be reliably determined up to now in vegetable fats, BfR adopts the hypothetical assumption that one kilogram of edible fat contains one milligram glycidol. Based on this calculation, BfR comes to the conclusion that infants who are fed exclusively industrially prepared infant milk formula would take in harmful levels of glycidol

Lowering blood pressure through a reduction of salt in foods

The majority of the German population consume too much salt. Young men, children and adolescents in particular consume a diet rich in salt. In some European countries, the salt content of processed foods has been reduced through systematic measures in recent years. Against this background, the Max Rubner Institute (MRI), the Robert Koch Institute (RKI) and the Federal Institute for Risk Assessment (BfR) have reassessed the data on the salt intake of the German population. In addition, information on what kind of foods especially contribute to high salt intake and the effect of salt-reducing actions on hypertension has been analysed. The BfR, MRI and RKI come to the conclusion that the average daily salt consumption of the German population of 9 grams for men and 6.5 grams for women is too high. The salt intake should be reduced to between 3.5 and a maximum of 6 grams per day. However, a diet low in salt is difficult to implement for consumers, because many processed foods contain salt. Among the foods which are principally responsible for the high salt intake are bread, meat, sausages, milk and cheese, although there are major differences within these types of foods. For example, hard cheese contains more salt than cream cheese. A recommendation to eat lower quantities of the foods listed above is difficult to realise, since they constitute an inherent part of the diet in Germany. For this reason, the BfR recommends that the salt content in processed foods such as bread, sausage and cheese is reduced. Without the “salt in the soup”, many foods seem tasteless and insipid. By gradually reducing their salt intake, however, consumers can quickly get used to the less salty taste. In addition, awareness should be raised in the population about the connection between salt consumption and health