Eating nanomaterials: cruelty-free and safe? the EFSA guidance on risk assessment of nanomaterials in food and feed

Nanomaterials are increasingly being added to food handling and packaging materials, or directly, to human food and animal feed. To ensure the safety of such engineered nanomaterials (ENMs), in May 2011, the European Food Safety Authority (EFSA) published a guidance document on Risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain. It states that risk assessment should be performed by following a step-wise procedure. Whenever human or animal exposure to nanomaterials is expected, the general hazard characterisation scheme requests information from in vitro genotoxicity, toxicokinetic and repeated dose 90-day oral toxicity studies in rodents. Numerous prevailing uncertainties with regard to nanomaterial characterisation and their hazard and risk assessment are addressed in the guidance document. This article discusses the impact of these knowledge gaps on meeting the goal of ensuring human safety. The EFSA's guidance on the risk assessment of ENMs in food and animal feed is taken as an example for discussion, from the point of view of animal welfare, on what level of uncertainty should be considered acceptable for human safety assessment of products with non-medical applications, and whether animal testing should be considered ethically acceptable for such products.     

The use of meta-analysis in food contact materials risk assessment

Abstract

As materials intended to be brought into contact with food, food contact materials (FCMs) – including plastics, paper or inks – can transfer their constituents to food under normal or foreseeable use, including direct or indirect food contact. The safety of FCMs in the EU is evaluated by the European Food Safety Authority (EFSA) using risk assessment rules. Results of independent, health-based chemical risk assessments are crucial for the decision-making process to authorize the use of substances in FCMs. However, the risk assessment approach used in the EU has several shortcomings that need to be improved in order to ensure consumer health protection from exposure arising from FCMs. This article presents the use of meta-analysis as a useful tool in chronic risk assessment for substances migrating from FCMs. Meta-analysis can be used for the review and summary of research of FCMs safety in order to provide a more accurate assessment of the impact of exposure with increased statistical power, thus providing more reliable data for risk assessment. The article explains a common methodology of conducting a meta-analysis based on meta-analysis of the dose-effect relationship of cadmium for benchmark dose evaluations performed by EFSA.     

Risk assessment for Clostridium botulinum: a network approach

The construction and implementation of a mathematical framework for the representation of the hazards that arise from Clostridium botulinum growth, and toxin production, in food are described. Botulism has been recognised as a serious foodborne illness for over a century and, more recently, has become the subject of increased concern due to changing processing and consumption patterns associated with foods. In this respect quantitative risk assessment has an increasingly important role to play in assisting risk management and ensuring the safety of minimally processed foods and foods with extended shelf life.Bayesian Belief Networks are a type of expert system that integrates a graphical, flow diagram like, representation of a hazard domain with a powerful technique for combining probabilities. This technique facilitates the accumulation of understanding and experience, for particular hazard domains, into computer tools that can be used to inspect risks and account for decisions.Analysis of the hazards associated with foodborne botulism involves Belief Network components that represent contamination processes, thermal death kinetics for spores, germination and growth of cells, toxin production and patterns of consumer behaviour, etc. These developments are discussed and three important aspects of the food safety information supply, complexity, dependency and uncertainty highlighted. The benefits associated with a Bayesian view of food safety assessment are illustrated by a Belief Network representation which supports, and prioritises, decisions and actions that (a) minimise the chances and extent of detrimental events and (b) maximise opportunities for awareness and control.     

Toxicological evaluation of genetically modified cotton (Bollgard<Superscript>®</Superscript>) and Dipel<Superscript>®</Superscript> WP on the non-target soil mite <Emphasis Type="Italic">Scheloribates praeincisus</Emphasis> (Acari: Oribatida)

Insecticides derived from the bacterium Bacillus thuringiensis (Bt) and plants genetically modified (GM) to express B. thuringiensis toxins are important alternatives for insect pest control worldwide. Risk assessment of B. thuringiensis toxins to non-target organisms has been extensively studied but few toxicological tests have considered soil invertebrates. Oribatid mites are one of the most diverse and abundant arthropod groups in the upper layers of soil and litter in natural and agricultural systems. These mites are exposed to the toxic compounds of GM crops or pesticides mainly when they feed on vegetal products incorporated in the soil. Although some effects of B. thuringiensis products on Acari have been reported, effects on oribatid mites are still unknown. This study investigated the effects of the ingestion of Bt cotton Bollgard and of the B. thuringiensis commercial product Dipel WP on the pantropical species Scheloribates praeincisus (Scheloribatidae). Ingestion of Bollgard and Dipel did not affect adult and immature survivorship and food consumption (estimated by number of fecal pellets produced daily) or developmental time of immature stages of S. praeincisus. These results indicate the safety of Bollgard and Dipel to S. praeincisus under field conditions where exposition is lower and other food sources besides leaves of Bt plants are available. The method for toxicological tests described here can be adapted to other species of Oribatida, consisting on a new option to risk assessment studies.     

Health risk assessment of arsenic in soils from three thermal power plants in Southwest China

Abstract

High levels of arsenic (As) contamination in soils from thermal power plants pose a great threat to human health. This study aimed to evaluate the As contamination levels and assess the possible health risk of As in soils from three typical thermal power plants in Southwest China. The concentration of As was detected by using novel collision/reaction cell technology (CCT) with inductively coupled plasma mass spectrometry (ICP-MS, collectively ICP-CCT-MS) after aseptic digestion of soil samples. The carcinogenic risk and hazard quotient were estimated for health risk to workers in the study area by using “Chinese Technical Guidelines for Risk Assessment of Contaminated Sites (HJ 25.3-2014)”. Results showed that the concentration of As was between 3.65 and 33.80?mg/kg, and the comprehensive carcinogenic risk level of As was 3–28 times over the maximum acceptable level (10^?6), indicating that workers in the study area are facing serious threat of As. Oral ingestion (76.65%) was the main exposure pathway to carcinogenic risk, followed by skin contact (13.15%) and inhalation of soil particles (10.20%). After calculating the safety threshold values under three different exposure pathways (oral ingestion, skin contact and inhalation of soil particles), the minimum safety threshold value (1.59?mg/kg) was selected as the reference safety threshold value of As in the study area. These results provide basic information of health risk assessment of As and environmental management in thermal power plant areas.     

中国森林健康生态风险评价

我国森林每年都在遭受诸如过度砍伐、火灾、病虫鼠害、酸雨、气象灾害等各种形式的干扰．这些干扰对我国森林生态系统的健康状况造成很大的威胁．因此,如何有效地管理我国的森林资源,特别是对森林的生态风险管理,提高森林生态系统抵御风险的能力,是森林生态系统健康研究和森林可持续管理的首要任务之一．森林健康生态风险评价是描述和评价人为活动、自然灾害和环境污染等胁迫因子对森林生态系统结构和功能、森林生态系统的健康状况产生不利影响的可能性和危害程度的评估,是森林资源管理的一个重要环节．以我国森林生态系统为例,探讨森林健康生态风险评价的研究方法,并以森林火灾、病虫害和酸雨为生态风险源,运用生态风险评价方法,分析了这些风险源对森林健康的主要危害,对我国森林健康的风险进行了综合评价,并提出不同森林风险区的管理策略．     

Uncertainties in the risk assessment of three mycotoxins: aflatoxin, ochratoxin, and zearalenone

The risk assessment of mycotoxins is made up of two major components: an exposure assessment and a hazard assessment. There are many uncertainties in both of these components. This paper will briefly discuss the various aspects of the risk assessment process as it applies to mycotoxins and will then focus mainly on some of the uncertainties in the hazard assessment component of several carcinogenic mycotoxins. To arrive at an estimated "safe dose" (end point of the hazard assessment), we have previously used two major approaches: the no observed effect level (NOEL) divided by a safety factor approach and a mathematical (robust linear) extrapolation to a "virtual safe dose." Both of these approaches use only points from the no observed effect region of the dose-response curve and ignore valuable data from the response region. It is proposed to use the dose at which 50% of the animals would have developed tumors (the TD50) divided by a large safety factor of 50,000 as an additional estimate of "safe dose". For many studies, the TD50 lies within the observed response region of the dose-response curve and may have more validity. It is also suggested in certain cases that some of the uncertainties regarding the NOEL can be reduced if one uses a statistically derived no effect level (NEL).     

Widespread environmental contamination in agricultural soils and human health risk at the vicinity of an oil refinery site

In this research, carcinogenic and non-carcinogenic human health risks due to polycyclic aromatic hydrocarbons (PAHs) were investigated via three exposure pathways: accidental ingestion of soil, dermal contact of soils, and contaminated vegetable ingestion. To determine the contaminant concentrations in soil, samples were collected from areas adjacent to the Tehran oil refinery, located in Shahr-e-Ray city, Iran. Analyses of the samples indicated that the average of PAHs concentration in the soil samples were greater than clean-up level guidelines. Cancer risk of contaminants due to ingestion of cultivated vegetables that are sold in Tehran markets was significant in comparison with other exposure pathways. Moreover, the total cancer risk for 5th percentile, 95 upper confidence limit, and 95th percentile concentration of contaminants were 5.69E-04, 8.78E-02, and 2.13E-01, classifying the site as having a significant cancer risk potential. Furthermore, non-carcinogenic health risk analyses for the contaminants demonstrated hazard index of less than 1. Remediation of the soils is highly recommended to eliminate the potential cancer risks and prevent the contamination of the food chain for approximately 10 million Tehran residents.     

Health Risk Assessment of Lead in the Republic of Korea

The purpose of this study was to estimate the daily exposure to lead due to food ingestion, air inhalation, and soil ingestion in the Republic of Korea's general population, and to evaluate the level of risk associated with the current lead exposure level using the proportional daily dose (3–4 μg/kg body weight/day) corresponding to the Provisional Tolerable Weekly Intake (PTWI) suggested by the Joint FAO/WHO Expert Committee on Food Additives as the toxicological tolerance level. The estimation of the daily exposure to lead via three pathways including food, soil ingestion and air inhalation was conducted as a chronic exposure assessment. For the lead exposure assessment through dietary intake, 1,389 lead residue data for 45 commodities investigated by the Korea Food and Drug Administration during the period 1995–2000 were utilized (KFDA 1996, 1997, 1998). Six hundred seventy-two air monitoring data from 7 major cities during the period 1993–2000 and 4,500 soil residue data at 1,500 sites during the period 1999–2001 were considered for the lead exposure assessment involving air inhalation and soil ingestion, respectively. The total daily exposure to lead was estimated by combining dietary intake, inhaled amount and soil intake corresponding to the typical activity of the general population, which was treated as a group of adults with a body weight of 60 kg. For risk characterization, the daily exposure to lead was compared with the toxicological tolerance level. The level of risk due to lead exposure was calculated using the hazard ratio (HR). The dietary intake of lead was 9.71 × 10_?4 mg/kg/day and the total daily exposure level, including air inhalation and soil ingestion, was 9.97 × 10_?4 mg/kg/day. The exposure contributions of foods, air and soil induced from the percentage of each media to the total daily exposure were 97.4%, 2.1% and 0.5%, respectively. Of the different commodity groups, the highest contribution to the total exposure came from grain, which represented 47.7% of the total. Additional exposure to lead occurs in certain population groups due to the use of tobacco, alcoholic beverages, and the intake of other foods, all factors not considered in this study. Through the comparison of the daily exposure to lead with the tolerance level based on the PTWI, the hazard ratio was estimated as being 0.25–0.33. This value implies that no increase in blood lead level is to be expected in the general population at the current lead exposure levels.     

风险矩阵分级模型在哈尔滨市食品安全风险评估中的建立与应用

目的:建立哈尔滨市风险矩阵分级模型,并应用该模型探索食品污染的风险。方法:采用风险矩阵、文献综述及专家判断法对某年食品安全风险监测中位列化学污染物及微生物污染超标率首位的食品-项目组合,即动物肝脏-克伦特罗组合、水产品-副溶血性弧菌组合进行模型评估。结果:参照风险矩阵,动物肝脏-克伦特罗组合的健康风险分值为6,可以判断哈尔滨市人群由于食用动物肝脏而导致克伦特罗膳食暴露的健康风险等级为"中风险",水产品-副溶血性弧菌组合的健康风险分值为2,可以判断哈尔滨市人群每餐由于食用水产品而导致副溶血性弧菌膳食暴露的健康风险等级为"极低风险"。结论:哈尔滨市该年食品安全总体情况较好,风险等级较低,但部分监测项目存在食品安全风险隐患,应予以关注。     

New approaches for risk assessment and management of bovine protothecosis

Protothecosis is a potential zoonosis related to bovine mastitis. In several countries, a higher incidence of protothecal bovine mastitis that is being recorded and the resistance of Prototheca species to various factors (chlorine, high temperatures, antimicrobial and antiseptic treatments, pH variations), make it difficult to control its spread among farms. The authors aim to describe the infection caused by microalgae, focusing on the problems within cattle farms and proposing new approaches to farm management, based on Regulation (EU) No 2016/429 on transmissible animal diseases. This new flexible approach, based on risk analysis, is a further tool in protecting against Prototheca species. The list of transmissible animal diseases under Regulation (EU) No 2016/429 includes those caused by microorganisms resistant to antimicrobials, which can have important implications for human and animal health, feed and food safety. This approach would involve a series of changes to the rules used for Official Controls (Regulation (EU) No 2017/625) moving from the concept of the food chain to that of the agri-food chain.     

Quantitative risk assessment of Listeria monocytogenes in ready-to-eat foods: the FAO/WHO approach

Quantitative microbiological risk assessment is a very new and unique scientific approach able to link, for the first time, data from food (in the farm-to-fork continuum) and the various data on human disease to provide a clear estimation of the impact of contaminated food on human public health. The Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) have recently launched risk assessment studies of a number of pathogen-food commodity combinations (Salmonella in eggs and in broiler chickens, Listeria monocytogenes in ready-to-eat foods, Campylobacter in broiler chickens, Vibrio in seafood) to be used to lower the risk associated with these food-borne diseases and ensure fair practices in the international trade of food. The FAO/WHO Listeria risk assessment was undertaken in part to determine how previously developed risk assessments done at the national level could be adapted or expanded to address concerns related to L. monocytogenes in ready-to-eat foods at an international level. In addition, after initiation of the risk assessment, the risk assessors were asked by the Codex Committee on Food to consider three specific questions related to ready-to-eat foods in general, which are: (1). estimate the risk for consumers in different susceptible populations groups (elderly, infants, pregnant women and immunocompromised patients) relative to the general population; (2). estimate the risk for L. monocytogenes in foods that support growth and foods that do not support growth under specific storage and shelf-life conditions; (3). estimate the risk from L. monocytogenes in food when the number of organisms ranges from absence in 25 g to 1000 colonies forming units per gram or milliliter, or does not exceed specified levels at the point of consumption. To achieve these goals, new dose-response relationships and exposure assessments for ready-to-eat foods were developed. Preliminary data indicate that eliminating the higher dose levels at the time of consumption has a large impact on the number of predicted cases.     

Detection of enterotoxin and toxic shock syndrome toxin 1 genes in Staphylococcus, with emphasis on coagulase-negative staphylococci

The detection of staphylococcal enterotoxins is decisive for the confirmation of an outbreak and for the determination of the enterotoxigenicity of strains. Since the recognition of their antigenicity, a large number of serological methods for the detection of enterotoxins in food and culture media have been proposed. Since immunological methods require detectable amounts of toxin, molecular biology techniques represent important tools in the microbiology laboratory. In the present study, polymerase chain reaction (PCR) was used to identify genes responsible for the production of enterotoxins and toxic shock syndrome toxin 1 (TSST-1) in S. aureus and coagulase-negative staphylococci (CNS) isolated from patients and the results were compared with those obtained by the reverse passive latex agglutination (RPLA) assay. PCR detection of toxin genes revealed a higher percentage of toxigenic S. aureus strains (46.7%) than the RPLA method (38.3%). Analysis of the toxigenic profile of CNS strains showed that 26.7% of the isolates produced some type of toxin, and one or more toxin-specific genes were detected in 40% of the isolates. These results suggests the need for further studies in order to better characterize the pathogenic potential of CNS and indicate that attention should be paid to the toxigenic capacity of this group of microorganisms.     

Occupational exposures and reproductive health: 2003 Teratology Society Meeting Symposium summary

Assuring reproductive health in the workplace challenges researchers, occupational safety and health practitioners, and clinicians. Most chemicals in the workplace have not been evaluated for reproductive toxicity. Although occupational exposure limits are established to protect 'nearly all' workers, there is little research that characterizes reproductive hazards. For researchers, improvements in epidemiologic design and exposure assessment methods are needed to conduct adequate reproductive studies. Occupational safety and health programs' qualitative and quantitative evaluations of the workplace for reproductive hazards may differ from standardized approaches used for other occupational hazards in that estimates of exposure intensity must be considered in the context of the time-dependent windows of reproductive susceptibility. Clinicians and counselors should place the risk estimate into context by emphasizing the limitations of the available knowledge and the qualitative nature of the exposure estimates, as well as what is known about other non-occupational risk factors for adverse outcomes. This will allow informed decision-making about the need for added protections or alternative duty assignment when a hazard cannot be eliminated. These policies should preserve a worker's income, benefits, and seniority. Applying hazard control technologies and hazard communication training can minimize a worker's risk. Chemical reproductive hazard training is required for workers by the Occupational Safety and Health Administration's Hazard Communication Standard. The National Institute for Occupational Safety and Health (NIOSH) has formed a National Occupational Research Agenda Team to promote communication and partnering among reproductive toxicologists, clinicians and epidemiologists, to improve reproductive hazard exposure assessment and management, and to encourage needed research.     

Application of bacteriophages for detection and control of foodborne pathogens

The incidence of foodborne infectious diseases is stable or has even increased in many countries. Consequently, our awareness regarding hygiene measures in food production has also increased dramatically over the last decades. However, even today’s modern production techniques and intensive food-monitoring programs have not been able to effectively control the problem. At the same time, increased production volumes are distributed to more consumers, and if contaminated, potentially cause mass epidemics. Accordingly, research directed to improve food safety has also been taken forward, also exploring novel methods and technologies. Such an approach is represented by the use of bacteriophage for specific killing of unwanted bacteria. The extreme specificity of phages renders them ideal candidates for applications designed to increase food safety during the production process. Phages are the natural enemies of bacteria, and can be used for biocontrol of bacteria without interfering with the natural microflora or the cultures in fermented products. Moreover, phages or phage-derived proteins can also be used to detect the presence of unwanted pathogens in food or the production environments, which allows quick and specific identification of viable cells. This review intends to briefly summarize and explain the principles and current standing of these approaches.     

Risks faced by laboratory workers in the AIDS era.

Laboratory workers are at occupational risk of exposure to microrganisms that cause a wide variety of diseases, from inapparent to life-threatening ones. Principal routes of transmission include percutaneous and permucosal inoculation (comprising clinical inapparent cutaneous or mucosal exposure to blood or blood products), inhalation, and ingestion. The appearance of the Acquired Immunodeficiency Syndrome (AIDS) epidemic and the first reports of occupational Human Immunodeficiency Virus (HIV) infections in health care workers resulted in high anxiety among laboratory workers. Indeed, 21% of worldwide documented cases of occupational HIV infection occurred among laboratory workers. Research laboratories pose the highest risk of infection. Safe methods for managing infectious agents ("containment") in the laboratory setting include laboratory practice and technique, safety equipment, and facility design. Infection control in the laboratory setting should take into account adherence to guidelines (biosafety levels), education and training, and the development of safety products designed to reduce the risk of exposure.     

外来植物的入侵机制及其生态风险评价

外来植物入侵已成为严重威胁生态系统健康发展的全球性问题,预防优于治理,对外来植物进行生态风险评价可有效地防御和降低入侵风险。本文基于生态风险评价理论,通过对外来植物入侵特性和过程的分析,探讨了外来植物入侵生态风险的评价方法。将评价程序分为风险源分析、风险受体评价、暴露与危害评价、风险综合评价和风险管理对策5部分,初步建立了风险源评价指标体系,以及度量生态损失和生态风险的指标和公式,进而得出外来植物入侵综合生态风险评价的方法。     

Diphtheria remains a threat to health in the developing world--an overview

Changes in the epidemiology of diphtheria are occurring worldwide. A large proportion of adults in many industrialized and developing countries are now susceptible to diphtheria. Vaccine-induced immunity wanes over time unless periodic booster is given or exposure to toxigenic Corynebacterium diphtheriae occurs. Immunity gap in adults coupled with large numbers of susceptible children creates the potential for new extensive epidemics. Epidemic emergencies may not be long in coming in countries experiencing rapid industrialization or undergoing sociopolitical instability where many of the factors thought to be important in producing epidemic such as mass population movements and difficult hygienic and economic conditions are present. The continuous circulation of toxigenic C. diphtheriae emphasizes the need to be aware of epidemiological features, clinical signs, and symptoms of diphtheria in vaccine era so that cases can be promptly diagnosed and treated, and further public health measures can be taken to contain this serious disease. This overview focused on worldwide data obtained from diphtheria with particular emphasis to main factors leading to recent epidemics, new clinical forms of C. diphtheriae infections, expression of virulence factors, other than toxin production, control strategies, and laboratory diagnosis procedures.     

Health risk assessment on heavy metals in urban street dust of Tianjin based on trapezoidal fuzzy numbers

The aims of this article were to investigate heavy metals concentrations in urban street dust of Tianjin, to examine spatial variations of heavy metals pollution, and to assess their health risk to local populations. Urban street dust samples were collected from 144 typical crossroads in an urban area of Tianjin. Levels of heavy metals were determined by atomic absorption spectrophotometer analyzer. Given comprehensive consideration of the complexity and uncertainty of health risk assessment, trapezoidal fuzzy number was introduced to assess the health risk of heavy metals in the urban street dust of Tianjin. The results showed that the pollution of heavy metals in the urban street dust of Tianjin was serious. The relatively serious metal pollution tended to be located in the center, north, northeast, and southeast of the study area. The research indicated that heavy metals in street dust had caused non-cancer hazard to children but had not caused non-cancer or cancer hazard to adults. The direct ingestion of dust via hand-mouth contact behaviors was the major exposure pathway for health risk.     

Assessing the Effects of Bt Maize on the Predatory Mite Neoseiulus cucumeris

The investigation of Neoseiulus cucumeris in the context of the ecological risk assessment of insect resistant transgenic plants is of particular interest as this omnivorous predatory mite species is commercially available and considered important for biological control. In a multitrophic feeding experiment we assessed the impact of Bt maize on the performance of N. cucumeris when offered spider mites (Tetranychus urticae) reared on Bt (Bt11, Syngenta) or non-Bt maize (near isogenic line) and Bt or non-Bt maize pollen as a food source. Various parameters including mortality, development time, oviposition rate were measured. Spider mites were used as a prey for N. cucumeris, since these herbivores are known to contain similar levels of Cry1Ab toxin, when reared on Bt maize, as those found in the transgenic leaf material. In contrast, toxin levels in pollen of this transgenic cultivar are very low. No differences in any of the parameters were found when N. cucumeris was fed with spider mites reared on Bt and non-Bt maize. Pollen was shown to be a less suitable food source for this predator as compared to spider mites. Moreover, subtle effects on female N. cucumeris (9% longer development time and 17% reduced fecundity) were measured when fed with pollen originating from Bt maize as compared to non-Bt maize pollen. Our findings indicate that the predatory mite N. cucumeris is not sensitive to the Cry1Ab toxin as no effects could be detected when offered Bt-containing spider mites, and that the effects found when fed with Bt maize pollen can be assigned to differences in nutritional quality of Bt and non-Bt maize pollen. The significance of these findings is discussed with regard to the ecological relevance for risk assessment of transgenic plants.