Risk Assessment Requirements Research Articles

South African food allergy consensus document 2014

The prevalence of food allergy is increasing worldwide and is an important cause of anaphylaxis. There are no local South African food allergy guidelines. This document was devised by the Allergy Society of South Africa (ALLSA), the South African Gastroenterology Society (SAGES) and the Association for Dietetics in South Africa (ADSA). Subjects may have reactions to more than one food, and different types and severity of reactions to different foods may coexist in one individual. A detailed history directed at identifying the type and severity of possible reactions is essential for every food allergen under consideration. Skin-prick tests and specific immunoglobulin E (IgE) (ImmunoCAP) tests prove IgE sensitisation rather than clinical reactivity. The magnitude of sensitisation combined with the history may be sufficient to ascribe causality, but where this is not possible an incremental oral food challenge may be required to assess tolerance or clinical allergy. For milder non-IgE-mediated conditions a diagnostic elimination diet may be followed with food re-introduction at home to assess causality. The primary therapy for food allergy is strict avoidance of the offending food/s, taking into account nutritional status and provision of alternative sources of nutrients. Acute management of severe reactions requires prompt intramuscular administration of adrenaline 0.01 mg/kg and basic resuscitation. Adjunctive therapy includes antihistamines, bronchodilators and corticosteroids. Subjects with food allergy require risk assessment and those at increased risk for future severe reactions require the implementation of risk-reduction strategies, including education of the patient, families and all caregivers (including teachers), the provision of a written emergency action plan, a MedicAlert necklace or bracelet and injectable adrenaline (preferably via auto-injector) where necessary.

Suicide risk categorisation of psychiatric inpatients: what it might mean and why it is of no use.

Existing suicide risk assessment policies and guidelines do not specify whether the risk to be assessed is absolute, relative to other patients or relative to the same patient at an earlier time. We utilised the results of a recent study of inpatient suicide to explore the implications of each of the above types of risk. No interpretation of the current requirements for suicide risk categorisation of psychiatric inpatients can lead to information that might usefully guide clinical decision-making. Policies and guidelines requiring suicide risk categorisation of inpatients should be withdrawn. The College should delete the mandatory entrustable professional activity requiring risk assessment.

Risk matrix model for rotating equipment

Different industries have various residual risk levels for their rotating equipment. Accordingly the occurrence rate of the failures and associated failure consequences categories are different. Thus, a generalized risk matrix model is developed in this study which can fit various available risk matrix standards. This generalized risk matrix will be helpful to develop new risk matrix, to fit the required risk assessment scenario for rotating equipment. Power generation system was taken as case study. It was observed that eight subsystems were under risk. Only vibration monitor system was under high risk category, while remaining seven subsystems were under serious and medium risk categories.

Pesticides in the Diets of Infants and Children: Twenty years of progress in assessing children’s dietary exposure to pesticides

Early lifestage exposure to certain pesticides has been associated with adverse health effects including neurobehavioral deficits and cancer. Protecting children from the effects of dietary pesticide exposure requires risk assessment methodologies that consider children's unique characteristics, such as less variety in diet and greater consumption of food per unit of body weight compared to adults. The U.S. National Academy of Sciences (NAS) called attention to these issues in publishing their landmark report Pesticides in the Diets of Infants and Children in 1993. Three years later, the U.S. Congress unanimously passed the Food Quality Protection Act (FQPA), requiring the Environmental Protection Agency (EPA) to implement several of the report's recommendations in its risk assessment processes, including using updated food consumption data based on children's dietary patterns, considering both cumulative and aggregate exposure, and incorporating an additional safety factor to better protect health during early lifestages. On the 20th anniversary of the report, we focus on the NAS recommendations which EPA is not legally mandated to incorporate in risk assessments, such as the use of probabilistic exposure distributions and data describing the impact of food preparation on residue levels. We discuss the extent to which EPA has implemented the recommendations that were not required by FQPA and the challenges faced in implementing the remaining recommendations. Finally, looking toward the future of risk assessment for children's dietary exposure to pesticides, we review recent recommendations from internal and external advisors and the peer-reviewed literature. We explore additional areas of focus, such as the use of epidemiological data in quantitative risk determinations and continued support of data collection on children's exposure to pesticides, and discuss remaining opportunities to improve the protection of children worldwide through dietary risk assessment.

Guidance on the use of respiratory and facial protection equipment

Infectious micro-organisms may be transmitted by a variety of routes, and some may be spread by more than one route. Respiratory and facial protection is required for those organisms that are usually transmitted via the droplet/airborne route, or when airborne particles have been artificially created, such as during ‘aerosol-generating procedures’. A range of personal protective equipment that provides different degrees of facial and respiratory protection is available. It is apparent from the recent experiences with severe acute respiratory syndrome and pandemic (H1N1) 2009 influenza that healthcare workers may have difficulty in choosing the correct type of facial and respiratory protection in any given clinical situation. To address this issue, the Scientific Development Committee of the Healthcare Infection Society established a short-life working group to develop guidance. The guidance is based upon a review of the literature, which is published separately, and expert consensus.

Risk categorization for calculating net reclassification improvement

Risk categorization for calculating net reclassification improvement

Perioperative management of anticoagulation in elective surgery

Surgeons commonly need to treat patients receiving anticoagulant and anti-platelet therapy. This requires risk assessment and management to balance minimization of bleeding complications and avoidance of further ischaemic or thrombotic events. This review considers the evidence available to guide management of patients on anti-platelet and anticoagulant therapy, including some of the new classes of anti-platelets and anticoagulants which clinicians may be less familiar with.

Counseling women with systemic lupus erythematosus who desire children

With the improvement of diagnosis and therapy, as well as advances in obstetric medicine, a large proportion of female systemic lupus erythematosus patients desire children and demand prepregnancy counseling. Planning a pregnancy means finding the right time and right conditions with low disease activity and therapy adjusted to pregnancy-compatible drugs. Counseling on birth control is necessary to avoid unplanned pregnancies, which carry high maternal and fetal risks. Prenatal counseling requires risk assessment regarding possible maternal or fetal risks, screening for biomarkers with predictive value for adverse pregnancy outcomes, adjustment of therapy and a schedule for monitoring and follow-up during pregnancy. Complications such as lupus nephritis, presence of antiphospholipid antibodies and risk of neonatal lupus syndromes require special attention.

Predictions for the spread, population density, and impacts of Corbicula fluminea in Ireland

In 2010, the Asian clam, Corbicula fluminea, was found for the first time in Ireland. The species is considered to be one of the most aggressive freshwater invaders causing strong economic and ecological impacts. This paper provides predictions for the spread, population density, and impacts of Corbicula fluminea in Ireland. Water chemistry datasets from the Republic of Ireland and from Northern Ireland were analysed to determine suitable waters for colonisation. Only 3 rivers and 6 lakes have pH levels considered too low (<5.6) for invasion of this species. Corbicula fluminea densities within a waterbody will depend on suitable substrate and food availability, with greater populations in canals, rivers and lakes with a higher trophic level. Boating and angling are likely to be the highest vectors of spread. Redevelopment of any canal sections will require risk assessment, to minimise spread. Corbicula is likely to cause negative economic effects by creating blockages in drinking and industrial water

Feasibility of mouse continuous intravenous infusion for fertility and embryo-foetal development studies

Developmental neurotoxicity (DNT) testing assesses potentially adverse effects on the developing nervous system. The present DNT study was conducted to generate historical data with the Wistar Han (WH) and Sprague Dawley (SD) rat strains, commonly used in Europe and the US, respectively. Potential differences between these strains in DNT endpoints have not been extensively investigated. Motor activity, startle response, learning and memory testing, and neurological (quantitative and qualitative) examinations were conducted using three groups of control, prenatally exposed (to Methylazoxymethanol [MAM] on gestation Day 15) and acutely treated (with IDPN, MK-801 or Chlorpromazine) animals for each strain. The positive controls produced clear effects in most endpoints investigated, with limited functional differences in baseline behavior and positive control sensitivity. However, SD rats were considerably more susceptible to MAM-induced learning and memory impairments and neurological damage. These data highlight differential sensitivity between the strains, which may require risk assessment consideration for developmental neurotoxicants.

Histology of selected organs from the Göttingen Minipig fetus from days 60 (mid term) and 110 (term) of gestation

Developmental neurotoxicity (DNT) testing assesses potentially adverse effects on the developing nervous system. The present DNT study was conducted to generate historical data with the Wistar Han (WH) and Sprague Dawley (SD) rat strains, commonly used in Europe and the US, respectively. Potential differences between these strains in DNT endpoints have not been extensively investigated. Motor activity, startle response, learning and memory testing, and neurological (quantitative and qualitative) examinations were conducted using three groups of control, prenatally exposed (to Methylazoxymethanol [MAM] on gestation Day 15) and acutely treated (with IDPN, MK-801 or Chlorpromazine) animals for each strain. The positive controls produced clear effects in most endpoints investigated, with limited functional differences in baseline behavior and positive control sensitivity. However, SD rats were considerably more susceptible to MAM-induced learning and memory impairments and neurological damage. These data highlight differential sensitivity between the strains, which may require risk assessment consideration for developmental neurotoxicants.

Scientific Opinion on Exploring options for providing advice about possible human health risks based on the concept of Threshold of Toxicological Concern (TTC)

Synthetic and naturally occurring substances present in food and feed, together with their possible breakdown or reaction products, represent a large number of substances, many of which require risk assessment. EFSA's Scientific Committee was requested to evaluate the threshold of toxicological concern (TTC) approach as a tool for providing scientific advice about possible human health risks from low level exposures, its applicability to EFSA's work, and to advise on any additional data that might be needed to strengthen the underlying basis of the TTC approach. The Scientific Committee examined the published literature on the TTC approach, undertook its own analyses and commissioned an in silico investigation of the databases underpinning the TTC approach. The Scientific Committee concluded that the TTC approach can be recommended as a useful screening tool either for priority setting or for deciding whether exposure to a substance is so low that the probability of adverse health effects is low and that no further data are necessary. The following human exposure threshold values are sufficiently conservative to be used in EFSA's work; 0.15 μg/person per day for substances with a structural alert for genotoxicity, 18 μg/person per day for organophosphate and carbamate substances with anti-cholinesterase activity, 90 μg/person per day for Cramer Class III and Cramer Class II substances, and 1800 μg/person per day for Cramer Class I substances, but for application to all groups in the population, these values should be expressed in terms of body weight, i.e. 0.0025, 0.3, 1.5 and 30 μg/kg body weight per day, respectively. Use of the TTC approach for infants under the age of 6 months, with immature metabolic and excretory systems, should be considered on a case-by-case basis. The Committee defined a number of exclusion categories of substances for which the TTC approach would not be used.

Differential performance of Wistar Han and Sprague Dawley rats in behavioral tests: Differences in baseline behavior and reactivity to positive control agents

Developmental neurotoxicity (DNT) testing assesses potentially adverse effects on the developing nervous system. The present DNT study was conducted to generate historical data with the Wistar Han (WH) and Sprague Dawley (SD) rat strains, commonly used in Europe and the US, respectively. Potential differences between these strains in DNT endpoints have not been extensively investigated. Motor activity, startle response, learning and memory testing, and neurological (quantitative and qualitative) examinations were conducted using three groups of control, prenatally exposed (to Methylazoxymethanol [MAM] on gestation Day 15) and acutely treated (with IDPN, MK-801 or Chlorpromazine) animals for each strain. The positive controls produced clear effects in most endpoints investigated, with limited functional differences in baseline behavior and positive control sensitivity. However, SD rats were considerably more susceptible to MAM-induced learning and memory impairments and neurological damage. These data highlight differential sensitivity between the strains, which may require risk assessment consideration for developmental neurotoxicants.

Synergistic approach of asteroid exploitation and planetary protection

The asteroid and cometary impact hazard has long been recognised as an important issue requiring risk assessment and contingency planning. At the same time asteroids have also been acknowledged as possible sources of raw materials for future large-scale space engineering ventures. This paper explores possible synergies between these two apparently opposed views; planetary protection and space resource exploitation. In particular, the paper assumes a 5 tonne low-thrust spacecraft as a baseline for asteroid deflection and capture (or resource transport) missions. The system is assumed to land on the asteroid and provide a continuous thrust able to modify the orbit of the asteroid according to the mission objective. The paper analyses the capability of such a near-term system to provide both planetary protection and asteroid resources to Earth. Results show that a 5 tonne spacecraft could provide a high level of protection for modest impact hazards: airburst and local damage events (caused by 15–170 m diameter objects). At the same time, the same spacecraft could also be used to transport to bound Earth orbits significant quantities of material through judicious use of orbital dynamics and passively safe aero-capture manoeuvres or low energy ballistic capture. As will be shown, a 5 tonne low-thrust spacecraft could potentially transport between 12 and 350 times its own mass of asteroid resources by means of ballistic capture or aero-capture trajectories that pose very low dynamical pressures on the object.

Climate change — An uncertainty factor in risk analysis of contaminated land

Metals frequently occur at contaminated sites, where their potential toxicity and persistence require risk assessments that consider possible long-term changes. Changes in climate are likely to affect the speciation, mobility, and risks associated with metals. This paper provides an example of how the climate effect can be inserted in a commonly used exposure model, and how the exposure then changes compared to present conditions. The comparison was made for cadmium (Cd) exposure to 4-year-old children at a highly contaminated iron and steel works site in southeastern Sweden. Both deterministic and probabilistic approaches (through probability bounds analysis, PBA) were used in the exposure assessment. Potential climate-sensitive variables were determined by a literature review. Although only six of the total 39 model variables were assumed to be sensitive to a change in climate (groundwater infiltration, hydraulic conductivity, soil moisture, soil:water distribution, and two bioconcentration factors), the total exposure was clearly affected. For example, by altering the climate-sensitive variables in the order of 15% to 20%, the deterministic estimate of exposure increased by 27%. Similarly, the PBA estimate of the reasonable maximum exposure (RME, defined as the upper bound of the 95th percentile) increased by almost 20%. This means that sites where the exposure in present conditions is determined to be slightly below guideline values may in the future exceed these guidelines, and risk management decisions could thus be affected. The PBA, however, showed that there is also a possibility of lower exposure levels, which means that the changes assumed for the climate-sensitive variables increase the total uncertainty in the probabilistic calculations. This highlights the importance of considering climate as a factor in the characterization of input data to exposure assessments at contaminated sites. The variable with the strongest influence on the result was the soil:water distribution coefficient (Kd).

Assessing, mapping and validating site-specific ecotoxicological risk for pesticide mixtures: A case study for small scale hot spots in aquatic and terrestrial environments

Mixture toxicity is a real world problem and as such requires risk assessment solutions that can be applied within different geographic regions, across different spatial scales and in situations where the quantity of data available for the assessment varies. Moreover, the need for site specific procedures for assessing ecotoxicological risk for non-target species in non-target ecosystems also has to be recognised. The work presented in the paper addresses the real world effects of pesticide mixtures on natural communities. Initially, the location of risk hotspots is theoretically estimated through exposure modelling and the use of available toxicity data to predict potential community effects. The concept of Concentration Addition (CA) is applied to describe responses resulting from exposure of multiple pesticides The developed and refined exposure models are georeferenced (GIS-based) and include environmental and physico-chemical parameters, and site specific information on pesticide usage and land use. As a test of the risk assessment framework, the procedures have been applied on a suitable study areas, notably the River Meolo basin (Northern Italy), a catchment characterised by intensive agriculture, as well as comparative area for some assessments. Within the studied areas, the risks for individual chemicals and complex mixtures have been assessed on aquatic and terrestrial aboveground and belowground communities. Results from ecological surveys have been used to validate these risk assessment model predictions. Value and limitation of the approaches are described and the possibilities for larger scale applications in risk assessment are also discussed.

A risk forecasting process for nanostructured materials, and nanomanufacturing

Abstract Nanomaterials exhibit novel properties that enable new applications ranging from molecular electronics to energy production. Proactive consideration of the potential impacts on human health and the environment resulting from nanomaterial production and use requires methods for forecasting risk associated with of these novel materials. However, the potential variety of nanomaterials is virtually infinite and a case-by-case analysis of the risks these materials may pose is not possible. The challenge of forecasting risk for a broad number of materials is further complicated by large degrees of uncertainty concerning production amounts, the characteristics and uses of these materials, exposure pathways, and a scarcity of data concerning the relationship between nanomaterial characteristics and their effects on organisms and ecosystems. A traditional risk assessment on nanomaterials is therefore not possible at this time. In its place, an evolving process is needed for analyzing the risks associated with emerging nanomaterials-related industries. In this communication, we propose that such a process should include the following six key features: (1) the ability to generate forecasts and associated levels of uncertainty for questions of immediate concern; (2) a consideration of all pertinent sources of nanomaterials; (3) an inclusive consideration of the impacts of activities stemming from nanomaterial use and production that extends beyond the boundaries of toxicology and include full life cycle impacts; (4) the ability to adapt and update risk forecasts as new information becomes available; (5) feedback to improve information gathering; and (6) feedback to improve nanomaterial design. Feature #6 implies that the potential risks of nanomaterials must ultimately be determined as a function of fundamental, quantifiable properties of nanomaterials, so that when these properties are observed in a new material, they can be recognized as indicators of risk. Thus, the required risk assessment process for nanomaterials addresses needs that span from urgent, short-term questions dealing with nanomaterials currently in commerce, to longer-term issues that will require basic research and advances in theory. In the following sections we outline issues surrounding each of these six features and discuss.

Prevention and management of TURP-related hemorrhage

Transurethral resection of the prostate (TURP) is the most common surgical treatment for benign prostatic hyperplasia (BPH) worldwide, but despite its minimally invasive nature, perioperative bleeding remains a common morbidity. Anticoagulant and antiplatelet medications are increasingly common in this patient population and further contribute to the risk of bleeding and extended hospital stay. Preoperative cessation of anticoagulant and antiplatelet drugs is recommended but requires risk assessment of thrombotic complications. Pharmacologic maneuvers to reduce hemorrhage include perioperative administration of 5α-reductase inhibitors. Technical considerations include the use of hemostatic energy sources such as laser and bipolar technologies. Ultimately, no surgical technique is devoid of bleeding risks, and urologists should be aware of how best to prevent and treat TURP-related hemorrhage.

Application of fuzzy logic to explosion risk assessment

Safety and health of workers potentially being at risk from explosive atmospheres are regulated by separate regulations (ANSI/AIHA in USA and ATEX in the European Union). The ANSI/AIHA does not require risk assessment whereas it is compulsory for ATEX. There is no standard method to do that assessment. For that purpose we have applied the explosion Layer of Protection Analysis (ExLOPA), which enables semi-quantitative risk assessment for process plants where explosive atmospheres occur. The ExLOPA is based on the original work of CCPS for LOPA taking into account an explosion accident scenario at workplace. That includes typical variables appropriate for workplace explosion like occurrence of the explosive atmosphere, the presence of effective ignition sources, activity of the explosion prevention and mitigation independent protection layers as well as the severity of consequences. All those variables are expressed in the form of qualitative linguistic categories and relations between them are presented using expert based engineering knowledge, expressed in the form of appropriate set of rules. In this way the category of explosion risk may be estimated by the semi-quantitative analysis. However, this simplified method is connected with essential uncertainties providing over or under estimation of the explosion risk and may not provide real output data. In order to overcome this problem and receive more detailed quantitative results, the fuzzy logic system was applied. In the first stage called fuzzification, all linguistic categories of the variables are mapped by fuzzy sets. In the second stage, the number of relation between all variables of analysis are determined by the enumerative combinatorics and the set of the 810 fuzzy rules “IF-THEN” is received. Each rule enables determination of the fuzzy risk level for a particular accident scenario. In the last stage, called defuzzification, the crisp value of final risk is obtained using a centroid method. The final result of the risk presents a contribution of each risk category represented by the fuzzy sets (A, TA, TNA and NA) and is therefore more precise and readable than the traditional approach producing one category of risk only. Fuzzy logic gives a possibility of better insights into hazards and safety phenomena for each explosion risk scenario. It is not possible to receive such conclusions from the traditional ExLOPA calculation results. However it requires the application of computer-aided analyses which may be partially in conflict with a simplicity of ExLOPA. The practical example provides a comparison between the traditional results obtained by ExLOPA and by fuzzy ExLOPA methods.

Challenges to improve confidence level of risk assessment of hydrogen technologies

Making large-scale distribution and use of hydrogen successful will require adequate risk control. In turn, control requires risk assessment. Despite many years of experience, in general, methods to determine risk lack still robustness: results being much too dependent on choices made by the analyst due to uncertainties, lack of data and different views. This can create frustration amongst people dependent on results. HySafe and other groups work in the right direction. This paper will review existing methodological weaknesses, current improvements in e.g. the context of developing risk-informed standards and emphasize the challenges to raise quality further. The Standard Benchmark Exercise Problems, SBEPs, were a good start but shall produce recommendations for CFD use or even certification of models. Scenario generation shall take advantage of historical incident data and newer methods such as Bayesian belief nets, and cover the entire hydrogen distribution system and not only garages and refueling stations; the analyses shall more explicitly present confidence intervals on results. Knowledge gaps on e.g. ignition probability shall be defined and filled.