Hazard Identification: Its Relationship to Risk Assessment, Risk Perception, and Regulation

Framing effects in risk communication messages – Hazard identification vs. risk assessment

Risk assessment of the impact of the enterprise's activities on the environment includes risk assessment of the impact of the activity on the health of the population. Risk as the probability of undesirable events is an integral component of any person's life. Risk characterization integrates data on the danger of the analyzed chemical substances, the amount of exposure, parameters of "dose-response" dependence, with the aim of quantitative and qualitative assessment of risk, identification and assessment of the comparative significance of existing problems for the health of the population. In scientific terms, hazard identification is the process of establishing a causal relationship between the action of a chemical substance and the development of adverse effects on human health. The main goal of the hazard identification stage is the selection of priority, indicator chemical substances, the study of which allows to reliably characterize the sources of occurrence and the level of risk of public health impairment. Assessment of dose-response relationships is a process of quantitative characterization of toxicological information and establishment of a relationship between the likely influencing dose (concentration) of a pollutant and the incidence of adverse events in the exposed population. Characteristics of "dose-response" dependence, which are most often used to assess carcinogenic risk, have been sufficiently studied in epidemiological studies. Among them is the factor of carcinogenic potential (ICS), which reflects the probability of the development of a harmful reaction when the dose (concentration) increases by 1 mg/kg or 1 mg/m3 per exposure level, associated with a certain probability of effect (the indicators of this group are used for establishment of reference, i.e., reference doses and concentrations). The individual carcinogenic risk characterizes the upper limit of possible carcinogenic risk during the period corresponding to the average life expectancy of a person (70 years). Today, in the world, the classification and assessment of the acceptable risk to the health of the population caused by the chemical influence of chemical substances that pollute the environment is quite wide. the system of acceptance criteria recommended by WHO is used. In accordance with these criteria, the first range of risk (individual lifetime risk equal to or less than 1·10-6, which also corresponds to an additional case of serious illness or death per 1 million exposed persons) characterizes such levels of risk as are perceived by all strata population as quite small, which do not differ from ordinary everyday risks (De minimas level). Such risks do not require additional measures to reduce them and their levels are subject to periodic control. The second range (greater than 1·10-6 and less than 1·10-4) corresponds to the zone of conditionally accepted (acceptable) risk. It is at this level that most of the foreign and recommended by international organizations hygienic standards for the population as a whole are established. Levels of suitable risk belong to constant control. The third range (greater than 1·10-4 and less than 1·10-3) is suitable for professionals and unsuitable for the general population. The emergence of such a level of risk requires the development and implementation of planned health measures. The fourth range (equal to or greater than 1·10-3) is unsuitable neither for the population nor for professionals. This range is designated as De manifestis Risk, and when it is reached, it is necessary to carry out emergency health measures to reduce the risk on the part of the city authorities. During the assessment of the risk to the health of the population of Zaporizhzhia from the emissions of PJSC "Ukrgrafit", priority pollutants were identified: carbon oxides, nitrogen oxides, sulfur oxides, substances in the form of suspended solid particles of undifferentiated composition. Hazard indices were determined for individual HQ substances (non-carcinogenic risks) and in the case of combined exposure to HI, individual carcinogenic risks (ICR) and combined exposure (CRa) were calculated. Assessment of long-term effects (at the level of average annual concentration) on human health of the investigated substances. allowing to assess the chronic inhalation effect of the occurrence of negative effects in the health of the exposed population during the lifetime for the assessment and characterization of multistage risk showed that the hazard indices (HQ) do not exceed the norms.

Work-Relatedness.

Risk assessment, consisting of hazard identification and risk analysis, is an important process that can prevent costly incidents. However, due to operational pressures and lack of construction experience, risk assessments are frequently poorly conducted. In order to improve the quality of risk assessments in the construction industry, it is important to explore the use of artificial intelligence methods to ensure that the process is efficient and at the same time thorough. This paper describes the adaptation process of a case-based reasoning (CBR) approach for construction safety hazard identification. The CBR approach aims to utilize past knowledge in the form of past hazard identification and incident cases to improve the efficiency and quality of new hazard identification. The overall approach and retrieval mechanism are described in earlier papers. This paper is focused on the adaptation process for hazard identification. Using the proposed CBR approach, for a new work scenario (the input case), a most relevant hazard identification tree and a set of incident cases will be retrieved to facilitate hazard identification. However, not all information contained in these cases are relevant. Thus, less relevant information has to be pruned off and all the retrieved information has to be integrated into a hazard identification tree. The proposed adaptation is conducted in three steps: (1) pruning of the retrieved hazard identification tree; (2) pruning of the incident cases; and (3) insertion of incident cases into the hazard identification tree. The adaptation process is based on the calculation of similarity scores of indexes. A case study based on actual hazard identifications and incident cases is used to validate the feasibility of the proposed adaptation techniques.

For the registration procedures of pesticides, the level of exposure during the various activities in which pesticides are handled has to be estimated. Different worker exposure models have been put forward in Europe and North America. These models are discussed and compared to each other for their output in terms of estimated levels of potential inhalation and dermal exposure. It is concluded that the output varies with the model, largely for two reasons. First, the underlying databases are completely different, which is inherent to locally different equipment and farm sizes. Second, the statistic used in the estimation of a level of exposure from a database varies from a geometric mean to the 90-percentile. The estimated levels of exposure may be used in a first step of the risk assessment. It is recommended that the relevant parts of all four models be considered to increase the representativity of the predicted level of exposure.

Effective immunization programs have markedly diminished the incidence of vaccine-preventable diseases. As a result, there now exists in society a lower awareness of the actual risks associated with the diseases themselves and a greater prominence of the potential risks of adverse effects associated with vaccines.Concern regarding public reactions to new vaccine safety issues may place pressure on policymakers and/or health care providers to act quickly in response to new information. However, this concern must be tempered by the necessary caution required to assess the intended and unintended risks and benefits of any action undertaken. The interplay of these potentially competing demands is well illustrated by the recent safety concern involving the use of thimerosal in vaccines.Thimerosal is a mercury-containing compound that has been widely used as an antimicrobial agent in vaccines for over 60 years. Human exposure to mercury may have potentially significant health consequences. By mid-1999, the Food and Drug Administration (FDA) had discovered that children could be exposed to an amount of mercury from vaccines that exceeded 1 of 3 existing federal safety thresholds. After this realization, the organized medical and public health communities in the United States became involved in a series of urgent and intense discussions to determine an appropriate response to the issue. This manuscript describes and analyzes the process that led to the July 7, 1999, joint American Academy of Pediatrics (AAP)/US Public Health Service (PHS) statement on thimerosal,1 with the goal of suggesting improvements for managing similar vaccine safety concerns in the future.We conducted structured interviews with over 15 individuals involved in the discussions and negotiations leading to the joint AAP/PHS statement on thimerosal. The individuals represented both the governmental agencies and nongovernmental organizations involved, including the FDA, the Environmental Protection Agency (EPA), the Centers for Disease Control and Prevention (CDC), the National Vaccine Program Office (NVPO), the AAP, and the American Academy of Family Physicians (AAFP). Interviews were conducted through face-to-face meetings or by telephone between January and April 2001. Table 1 lists the individuals interviewed who allowed their identities to be published.The development and implementation of immunization policy in the United States is a cooperative effort among many entities in the public and private sectors (Table 2).The concern over thimerosal in vaccines originated from a confluence of independent events, 1 informal and 1 formal, within the FDA. In the spring of 1998, some individuals within the FDA's Center for Biologics Evaluation and Research (CBER) began to informally consider the increased number of recommended vaccines and the amount of substances, such as mercury, contained in them to which vaccine recipients were exposed. Available literature to help quantify their concern was limited.The formal identification of thimerosal as a concern arose through the FDA's efforts to comply with the Food and Drug Administration 2Modernization Act.2 As mandated by Congress, Section 413(a) of the Act required the FDA to compile a list of drugs and foods that contain "intentionally introduced" mercury compounds and to provide a quantitative and qualitative analysis of these compounds within 2 years of the Act's enactment.The FDA's previous formal review of thimerosal in biological products had occurred in 1976. The convergence of concerns over mercury in vaccines that occurred within the CBER beginning in April 1998 prompted the agency to reassess the risks of thimerosal.3One of the steps of this risk assessment was to investigate the potential exposure of humans to thimerosal in vaccines. Based on the information submitted by industry and FDA internal data, the CBER determined that thimerosal was present in over 30 licensed vaccines in the United States.4,5 The amount of mercury by weight present in each of these vaccines was calculated. The CBER then referred to the recommended childhood immunization schedule to determine the amount of mercury to which young children may be exposed. Of the vaccines that a child could receive in the first 2 years of life, those that contained thimerosal were the 2 available formulations of the hepatitis B vaccine and some formulations of the diphtheria-tetanus-acellular pertussis and Haemophilus influenzae type b vaccines. Looking at cumulative exposure over the first 6 months of life, an infant 6 months old who received all recommended vaccine doses on schedule could be exposed to up to 187.5 μg of mercury.Another step in the risk assessment process was to determine whether thimerosal actually constituted a true health risk; that is, whether there were data demonstrating that this amount of mercury could be potentially harmful to children. To identify whether there were any known health risks from exposure to thimerosal, the CBER conducted a literature review and queried the Vaccine Adverse Event Reporting System, a national surveillance system for voluntarily reported adverse events associated with vaccines. The CBER found that at low doses, thimerosal has been associated with rare hypersensitivity reactions, such as persistent skin sensitization at the site of vaccination. At very high doses (ie, 1000 times higher than levels found in vaccines), thimerosal has been reported to cause neurologic and renal toxicity.An early assessment of the health risks of all forms of mercury by the World Health Organization (WHO) found that insufficient information was available to perform risk calculations for human exposure to ethyl mercury compounds, the type of mercury contained in thimerosal.6 However, the WHO did note that the limited data available suggested that ethyl mercury was probably less hazardous than methyl mercury, because it is metabolized faster in the body.The WHO and 3 US governmental agencies—the FDA, the EPA, and the Agency for Toxic Substances and Disease Registry (ATSDR)—had developed independent guidelines for safe exposure to methyl mercury (Table 3).7–10 Because no guidelines exist for ethyl mercury exposure, the FDA used the guidelines for safe exposure to methyl mercury as a guide for determining whether the mercury (ethyl) dose from thimerosal in vaccines approached a level of concern or health risk.The existence of 3 differing US federal guidelines for methyl mercury was a source of confusion and contention in determining the appropriate response to concern regarding thimerosal in vaccines. Each agency developed their guidelines for different purposes. The most conservative of these guidelines was the level established by the EPA to serve as a warning of mercury in the environment to trigger additional investigation. The ATSDR guideline is set below levels that might cause an adverse health impact in those most sensitive to a particular substance. The FDA guidelines were developed as safe limits for long-term consumption of food contaminated with mercury, particularly fish, which is the main exposure route of humans to methyl mercury. No guidelines were available to assess the risk of exposure in bolus doses by intramuscular injection.Nevertheless, the existing methyl mercury guidelines were the best information available at the time for assessing risk from ethyl mercury exposure. The CBER calculated exposure limits for each of these guidelines based on the average weight at various percentiles in female infants between birth and 26 weeks of age (Table 4). Based on these calculations, the CBER determined that potential exposure to mercury from the recommended childhood vaccines in the first 6 months of life could exceed the EPA methyl mercury guideline, but not the ATSDR, FDA, or WHO guidelines. However, the CBER was unable to determine with certainty whether exposure to thimerosal in vaccines was harmful.In April 1999, results from the preliminary risk assessment were discussed at an internal FDA meeting, and participants realized that there was a clear need for additional data. The CBER began to consult with toxicologists both within the FDA and at the National Center for Environmental Health, and several vaccine researchers, including Neal Halsey, MD, Director of the Institute for Vaccine Safety at Johns Hopkins University. The FDA also initiated discussions with vaccine manufacturers regarding the need to develop thimerosal-free vaccines.3Dr Halsey was invited by the FDA to an internal meeting in mid-June 1999 where he was asked to provide feedback on the results of their preliminary risk assessment regarding thimerosal. On learning of the FDA data, and personally verifying the calculations of the levels of mercury to which children could be exposed, he believed that the issue warranted serious concern and urgent action. At the time, Dr Halsey was soon to complete his term as Chair of the AAP Committee on Infectious Diseases (COID). Dr Halsey previously worked within the CDC's immunization program and had been a member of the Advisory Committee on Immunization Practices (ACIP). As such, he had extensive experience and professional relationships within the US immunization policymaking arena. Beginning around June 24, 1999, Dr Halsey informed many of these contacts of his concern regarding the potential health effects of thimerosal and the results of the FDA's preliminary risk assessment. After notifying the Director of the CDC's National Immunization Program, Dr Halsey met with CDC personnel at the National Immunization Conference on June 25. He also informed several other individuals, including the incoming Chair of the COID, the Chair of the ACIP, and a member of the AAP Board of Directors. In addition to his concern regarding the potential health effects of mercury exposure in infants, Dr Halsey expressed the need for urgent action on the issue because the FDA was planning to send a letter to vaccine manufacturers in the beginning of July 1999 regarding the need to remove thimerosal from vaccines, at which point the information about thimerosal would become public. He believed that publicity surrounding this issue, without action on the part of the PHS and/or the AAP, could result in long-term damage to public confidence in the national immunization system.After Dr Halsey informed these initial contacts of his concerns regarding thimerosal, conversations began to occur among the parties. The Interagency Vaccine Group (IAG) held a conference call on June 28 and reviewed the information from the FDA's preliminary risk assessment. After this call, the IAG formed a special workgroup to address the thimerosal issue. CDC immunization officials also conferred with the AAP, vaccine companies, and internal CDC toxicologists.Significant differences of opinion surfaced regarding the accuracy of the exposure and risk-assessment information concerning thimerosal, its importance, and the need for any immediate discussion or action.To quickly bring representatives of several organizations involved in immunization policymaking together to discuss the issue, a meeting was organized by Dr Halsey and Dr Cooper for June 30, 1999, at the AAP offices in Washington, DC. The selection of the venue for this meeting was deliberate. The initial course of action for the government normally would have been for the ACIP and the National Vaccine Advisory Committee (NVAC) to meet to discuss the issue. However, governmental advisory boards are required by the Federal Advisory Committee Act to provide adequate public notice of meetings and publish meeting agendas in the Federal Register. Given how quickly some individuals believed a meeting should occur, it was not possible to officially convene these advisory bodies in such a short time frame. By having an informal meeting at the offices of the AAP, a frank discussion of the scientific and biological veracity of all available information could take place without delay. As a result, however, this meeting precluded the formal involvement of the ACIP and the NVAC.Drs Cooper and Halsey developed a list of invitees, which included representatives of the CDC, FDA, EPA, AAP, vaccine manufacturers, and toxicologic consultants. An initial goal of the meeting was to achieve consensus on a course of action, as many believed that public presentation of differing views would likely confuse practitioners and parents, and potentially undermine confidence in the national immunization system.At the meeting, FDA representatives shared the results of their preliminary risk assessment, outlining what was known and unknown about the issue and describing the difficulties in determining whether the level of mercury in vaccines should be of concern. Because of the complexities in interpreting the data regarding the potential risk of harm from thimerosal, there was disagreement among the parties present as to its significance. Disagreements existed between organizations, within organizations, and among the toxicologists present at the meeting. Some participants believed strongly that the potential threat to health from thimerosal was significant; others believed that there was no clear evidence that thimerosal was harmful, particularly when compared with the clear health risks of delaying childhood vaccines. The 2 AAP committees represented at the meeting, the COID and the Committee on Environmental Health, were in sharp disagreement on this point. There was also a varied sense of exigency, with some participants believing that urgent action was required, whereas others thought the process should slow down to include other parties in the discussion and address perceived significant gaps in the scientific data. Actions proposed by participants at the meeting ranged from immediately stopping administration of all vaccines containing thimerosal to children under 6 months of age to encouraging vaccine manufacturers to expedite the elimination of thimerosal from vaccines.An overriding concern expressed by all parties at the meeting was the need to maintain the public's trust in the US immunization system by striking the appropriate balance between acknowledgment of the potential risk of harm from thimerosal and the actual risk of harm from not immunizing against vaccine-preventable diseases.It became clear during the June 30, 1999 meeting that no consensus would be reached that day regarding an appropriate course of action. Sharp disagreements regarding the clinical significance of thimerosal exposure were not resolved. Specific individuals who felt most strongly regarding the potential health risk of thimerosal exposure stated that they would independently make public statements if their respective organizations did not support their contentions. The meeting concluded with all participants agreeing that no statement would be released by any individual or organization until after the July 4th weekend, and that discussions between the PHS and the AAP would continue in an attempt to achieve a unified public statement. Leadership in both the AAP and the PHS believed that releasing a joint public statement was crucial for preserving the public's trust in the immunization system.PHS officials in the CDC and elsewhere believed that vaccine manufacturers should be encouraged to expedite the elimination of thimerosal from vaccines, but did not want to make any changes to the childhood immunization schedule. However, CDC officials also felt strongly that it would be in the best interests of the national immunization system and the public's trust for a statement to be developed jointly with the AAP. This prompted David Satcher, MD, PhD, the US Surgeon General and Assistant Secretary for Health, to be involved in the negotiations.After the June 30 meeting, there was significant debate within the AAP as to the appropriate course of action to be taken. Over the next several days, there was constant reconsideration and revision of positions taken among both individuals and committees.On review of available information and opinions, the AAP Board of Directors decided to put forth the position in their negotiations with the PHS that the birth dose of the hepatitis B vaccine be temporarily delayed. They considered the risk of disease to be low except for infants of HBsAg-positive mothers. The Board of Directors believed that hospitals should already have procedures in place to determine the hepatitis B status of mothers and treat the infants of HBsAg-positive status mothers appropriately.Other parties were informally involved in the discussions leading to the joint statement. The AAFP did not think the issue warranted such urgency and believed that the health effects data for methyl mercury on which the EPA guidelines were based were questionable.Many conference calls, meetings, and sharing of draft statements occurred within and between the AAP and the PHS over the course of the July 4, 1999 holiday weekend. The Surgeon General held several discussions with the AAP president to negotiate a compromise position. Although they were extremely concerned about both the short- and long-term consequences of delaying administration of the hepatitis B vaccine, PHS officials agreed to the recommendation to present a unified position to the public.The joint statement was officially released in the late afternoon of July 7, 1999,11 and was published in the MMWR Morbidity and Mortality Weekly Report on July 9, 1999.1First and foremost, it is clear that all parties involved in this process acted in the manner they believed was in the best interest of children in the United States. Even parties that differed most strongly never doubted the intent or purpose of those with whom they disagreed.Only 2 weeks transpired between the time that leaders of the major national organizations involved in US immunization policy learned about the issue of thimerosal in vaccines and the release of the joint AAP/PHS statement. During that time, these individuals and their organizations worked diligently to develop a response that they believed balanced the potential risk from exposure to thimerosal with the actual risk of vaccine-preventable disease and would ensure continued public confidence in the nations' immunization system. Considering the complexity of the information available and the gaps in information relevant to specific concerns, it is not surprising there was significant disagreement regarding the potential risk associated with thimerosal. To some, the process could be considered a success, in that compromise was reached and the "crisis" was addressed. However, others have publicly the that the recommendation to the birth dose of hepatitis B vaccine practitioners and put infants at risk for hepatitis B vaccine as to that the process was a of how not to public health of the IAG would have first learned of the thimerosal issue from FDA who would have informed the of its review of the thimerosal in vaccines. In this however, an individual of the government was the first to many of these soon the FDA should have is a of as is how information should have been other parties. The FDA was to an issue with the IAG when there were many surrounding the potential health risks In the FDA must be sensitive to issues to any under its IAG is to among federal agencies with vaccine issues through meetings and other To the IAG must achieve a balance between that are informed of and agencies to data to other parties the information is released to the public. such to be there must be confidence among the parties that their all from and shared efforts with each the must be as independent and to its of this issue is to ensure that the and of the are not under the or perceived or of any the through the that serious be by the Office of the Secretary for Health and Human to the of the of the including the of and the of meeting that occurred at the AAP offices in Washington, on June 30, 1999, was a in the discussions leading to the joint statement. the of this type of meeting and the in which it was organized was for the AAP, the of action was of the of the Board of are as to the of who or was concern expressed from many was the of vaccine industry representatives at the meeting. The meeting occurred the time of the vaccine safety in Congress, and in a environment in which of between industry and immunization policymakers had been Some participants at the meeting believed that having industry representatives at a meeting could have this may also have the of some meeting the of the vaccine industry to a immunization system be Vaccine manufacturers a of vaccine development and and their in different of immunization policy is concern is that some parties did not in this meeting such as the AAFP or representatives of hospitals that would be by the in the hepatitis B the of the 2 federal immunization advisory the ACIP and the did not in the initial thimerosal because of the perceived of the Federal Advisory Committee Act on meetings on very short The CDC and the have reviewed the and have found that exist for meetings on an to the birth dose of hepatitis B vaccine was not taken by any to the the risk of thimerosal exposure with the known risk of of hepatitis B disease was for However, in some leading to the joint AAP/PHS of the potential impact of delaying the birth dose of the hepatitis B vaccine did not receive some in of stopping the birth dose of hepatitis B vaccine, there was acknowledgment of the potentially significant of the of hospitals the the for this policy to these or the of procedures for determining the hepatitis B status of mothers. There to be effort to the existing literature on the impact of changes in immunization and the times for the of there was an confidence by some in the of hospitals to all mothers for hepatitis B status previous had of such of the impact of the joint statement on infant hepatitis B are now beginning to be have that some hospitals all with hepatitis B vaccine, including those to HBsAg-positive possible is the of information or of the recommendation by hospitals and Because of the of appropriate for and the hepatitis B status of this in policy has led to the of at 1 infant from hepatitis have also that many hospitals have not to doses of the hepatitis B vaccine the of thimerosal-free The of the first dose of hepatitis B vaccine at birth is illustrated by a recent that that children who received the first dose at birth were likely to complete the hepatitis B times of regarding immunization that all parties involved to the short- and long-term intended and unintended consequences of their proposed This type of analysis could take the of the and structured risk assessment process used by other government such as the of the major issues concern and urgency among all parties was the manner in which the would the issue. over the accuracy of in and for vaccine issues in is well However, an overriding issue is the of how should concern over the time of for public or individual health with policymaking must balance concern over the risk of public regarding safety issues with concern over the to ensure that information be to the public.The FDA the safety and of products they are for use and the process of a constant of products available to However, the of thimerosal an to FDA In the when thimerosal was for use in this there were limited available to assess for the of there is no for the FDA to vaccine with is in to some other federal such as the In was that be by the EPA years. Because no such process has been for the FDA, thimerosal not In for a containing mercury, the of most concern is on system At this time, the FDA has no for of the products it the FDA not have a to identify the cumulative amount of thimerosal, which children would receive over the course of the recommended immunization schedule. Each vaccine was for use as an independent agent and the amount of thimerosal contained in each individual vaccine no concern. was when the cumulative amount from all the vaccines contained in the recommended immunization schedule was calculated that concern that should consider to the FDA the to perform of vaccine In that the FDA its and the FDA develop a for of the cumulative amount of to which individuals may be exposed as a result of specific federal of the issues to all parties involved was the existence of differing federal for exposure to mercury from the EPA, the FDA, and the Although each agency had a different purpose in a specific safety the that there was no clear federal consensus on this issue was This allowed different parties to the discussion to over to support their federal agencies that have differing safety for exposure to specific to develop a federal consensus on safe exposure levels determine under which the different guidelines are to be than 1 federal is each agency should be with the for determining a different safety AAP is an organization for its to the of the health and of children. the internal debate that place within the AAP on this issue involved disagreement on the course of action that would be of to the children of the United AAP Board of Directors to its committees for and information regarding specific issues on which it must set However, the exists that the course of within the was in some than the Board of Directors on this issue from specific individuals were to the they may have represented the of the AAP is very that all be to maintain use of this in times of This help ensure that the consensus of than specific individuals, are to help guide the AAP Board of Directors regarding policy have on a of immunization The of these has been and At point efforts have been to information of those involved in immunization policy and in the or review of from the Institute of are now to in such committees for of and having their publicly and public if have the potential to cause significant and professional involvement of leading in the on childhood vaccines were to soon after the June 30, 1999, meeting at the AAP As such, concern over the manner in which any action or might be perceived in this type of environment a of concern and over many this was perceived as a course of action under by a process not in the best interests of the immunization system or children. This also to the development of a and the to act in interviewed but not of the parties involved in this As such, have an and assessment of the events that place in late June and early July However, there exists the that some information may not have been In these interviews were conducted 2 years after this process there may be some of the information process that in the in immunization as a result of concern to thimerosal was and Although there are significant differences of opinion regarding the of the the immunization system in the United States and was by the Program for and Health,

Risk assessment provides a proactive and logical ground for many decision-making processes. Although the approach of risk assessment nowadays is well established, it remains a relatively new research area, with increasing interest in understanding the principles that underpin the practice. In the review of computer models and literature on environmental risk assessments in general and the risk analysis of waste disposal sites in particular, the authors have determined that a comprehensive risk assessment methodology covering all modules and sub-modules for landfill leachate does not exist. The same fact holds for landfill gas and degraded landfill waste (although these are both beyond the scope of this paper). A range of knowledge deficiencies is identified in the literature. One such deficiency is the development of a strategic procedure for carrying out Hazard Identification and Categorization for risk assessment of landfill leachate, assisted with a corresponding computer model. This study, with reference to the relevant literature, discusses the extent to which the Hazard Identification and Categorization procedure is absent in landfill risk analysis approaches. The elements, which should be added to such a procedure in order to more effectively underpin landfill risk assessments, are also indicated.

Non-animal procedures, including in vitro test systems and test strategies, can already make a significant contribution to the background to risk assessment — in predicting both the toxic potential and toxic potency of chemicals, as well as, in some circumstances, the toxic hazard they may represent under specified conditions of exposure. They can be particularly useful for investigating molecular and cellular mechanisms of chemical-induced toxicity, and for identifying species-specific effects, which greatly limit the value of data from laboratory animal studies in the human risk assessment process. Attention is focused on the need for greater effort to be invested in the development of non-animal procedures for evaluating the biokinetic factors which will determine the ultimate form and concentration of a particular chemical at possible sites of toxic action. The relative merits of correlative and mechanistic approaches to test development and test validation are discussed. The need for realism is emphasised, not only in relation to our expectations of the validation process, but also in terms of the current and future status of regulatory toxicology, in vitro or in vivo, as a scientific discipline. Finally, it is concluded that the intelligent and strategic use of in vitro test systems, in conjunction with predictive computer modelling, could markedly improve the scientific basis of human risk assessment.

Methodologic Issues in Epidemiologic Risk Assessment

Science linking environmental contaminant exposures with fertility and reproductive health impacts in the adult male

Objectives: Exposure Assessment for workplace hazards where the exposure level is below occupational exposure limits(OELs) has been performed without considering either the degrees of risk or exposure levels and has failed to lead to intervention in many cases. The objective of this study was to suggest and test an application framework for risk assessment methodology under the current exposure assessment system in Korea. Materials: First, we investigated the exposure assessment systems in Korea and other countries. To adopt some risk assessment techniques, we also analyzed risk assessment systems and compared them to exposure assessment systems. A few suggestions were made. We held a public hearing during an industrial hygiene conference and took surveys using a questionnaire. Results: The first suggestion was to implement the risk assessment and exposure assessment through a "one-stop" system. In that case, one expected question would be who has been doing the jobs so far. In most cases, industrial hygiene consulting services or laboratories have been performing exposure assessment for business owners. Business owners are required to perform risk assessment. As two different groups of people will be required to implement two things in a one-stop system, they need to share information. As an information vehicle to share information, commonly filed survey checklists were suggested. The second suggestion was to categorize exposure level into four groups instead of the current binary divisions based on OELs. In the risk assessment system, exposure level is divided into four groups utilizing the cut-points of 10%, 50%, and 100% of OELs. The same schema can be adopted in the exposure assessment system and different levels of requirements can be assigned for each group. The third suggestion was regarding the regulation system. To provide the suggestions some thrust toward being implemented in the field, changes should be made in the legal system. Two different types of new exposure assessment result reporting forms were suggested. Some investigations such as an ergonomic survey are officially accepted as risk assessment under the current legal system. A few items were suggested to be included in the exposure assessment result reporting to be accepted as risk assessment. A pilot study in two small factories was performed and pointed out the strengths and weakness of our suggestions. Conclusions: Discussions and studies on the improvement of the exposure assessment system have been held for decades and no tangible changes have yet been made. We hope this result can help realize healthy lives for workers in Korea.

Optimising the Elements of a Construction Health and Safety (H&S) Programme and Audit System

Purpose This study aims to design and validate a decision support system (DSS), named preliminary risk assessment of brownfield sites (PRABS). It is intended that the proposed DSS will aid the identification of potential hazards and, in doing so, highlight challenges facing those stakeholders dealing with the decision-making on brownfield site redevelopments, where the examples of diverse stakeholders would include, for instance, risk assessors, local planning authorities, regulator, developers, civil engineers, architectures, landowners, investors and alike. Moreover, the DSS will enable them to promote safer redevelopment and minimise the risks to future occupants of brownfield sites and neighbouring lands, on the top of the tool being communal platform of an effective communication between them as it is for both experts and non-experts. Design/methodology/approach This research employs a comprehensive five-stage process, integrating both quantitative and qualitative methods and utilizing mixed methods for a nuanced exploration of data. The initial stage involves an in-depth examination of contemporary risk assessment tools for contaminated sites, setting the foundation and benchmarks for subsequent stages. Stage two focuses on creating a conceptual framework using insights from existing literature to guide the development of the DSS tool. Stage three introduces a validation mechanism through a questionnaire administered to experts. Stage four involves the active development of the DSS tool, transforming theoretical constructs into a practical application. The final stage, stage five, employs quantitative data analysis and case studies to validate, refine and enhance the DSS tool’s applicability in real-world scenarios, ensuring its approval. Findings This study presents PRABS, a user-friendly DSS for the PRABS. Validation through a quantitative online survey indicates strong support for PRABS, with around 80% of participants willing to recommend it due to its ease of use and information quality. Qualitative data analysis using real-life case studies further demonstrates the tool’s effectiveness. PRABS proves valuable in identifying hazards during the preliminary stage, accurately predicting potential contaminants despite limited input data in the case studies. The tool’s hazard identification aligns well with expert judgments and case study reports, confirming its practical utility. Practical implications This study has several limitations. First, the DSS identifies only hazards associated with one layer of site geology, even though sites may include multiple layers, which limits the comprehensiveness of the hazard identification process. Second, adopting an online survey approach posed challenges in achieving a high response rate and gathering a representative sample, making it uncertain how the results might vary with a higher number of professional participants. This limitation affects the generalisability of the findings. Finally, while this study identified 65 potential hazards associated with brownfield sites, this number could be expanded to include hazards related to plants, animals and air, indicating the need for a more inclusive approach to hazard identification. Given these limitations, future research should focus on addressing these gaps. Originality/value The contributions of this study offer practical benefits. Firstly, it enables the initial risk assessment process to be more comprehensive and integrated and reduces complexity in the risk assessment process by ensuring that all probabilities, along with their significance, are identified at the initial stage of the risk assessment. This could be a strong starting point for successfully conducting a more detailed risk assessment and remediation. Secondly, the developed PRABS can promote effective environmental communication among stakeholders, which should speed up the planning process and help develop brownfield sites more efficiently and effectively, while preserving the natural environment.

Foodborne Microbial Pathogens in World Trade: Foodborne microbial pathogens Chronic sequelae following foodborne illness Emergence and re--emergence of foodborne pathogens and toxins Changes in host susceptibility and exposure Processing methods and globalisation of the food industry Changes in consumption pattern Immunological status Malnutrition Changing perceptions and values Risk of food poisoning The cost of foodborne diseases International control of microbiological hazards in foods Sanitary and Phytosanitary (SPS) Agreement Origin of microbiological risk assessment. Food Safety, Control and HACCP: Outline of HACCP Food hazards Pre--HACCP Principles Principle 1 Hazard Analysis Principle 2 Critical Control Points Principle 3 Critical Limits Principle 4 CCP Monitoring Principle 5 Corrective Actions Principle 6 Verification Principle 7 Record--keeping Control at source Product design and process control Intrinsic and extrinsic factors affecting microbial growth Irradiation High Pressure Technology Temperature control of microbiological hazards Microbial response to stress Response to pH stress Heat-- and cold shock response Response to osmotic shock Response to high hydrostatic pressure Predictive modelling Primary models and the Gompertz and Baranyi equations Secondary models Tertiary models Microbiological Criteria Attributes sampling plan Operating characterisitic curve. Risk Analysis: Overview of Microbiological Risk Assessment Risk Assessment Risk Management Risk Communication Risk Assessment Statement of purpose Hazard Identification Exposure Assessment Hazard Characterization Preface Dose--response assessment Dose--response models Dose and infection Risk Characterization Production of a formal report Triangular distributions and Monte Carlo simulation Risk Management Risk assessment policy Risk Profiling Food Safety Objectives Risk Communication. Application of Microbiological Risk Assessment: Salmonella spp. S. Enteritidis in shell eggs and egg products Hazard identification and hazard characterization of Salmonella in broilers and eggs Exposure assessment of Salmonella Enteritidis in eggs Exposure assessment of Salmonella spp. in broilers Salmonella spp. in cooked chicken Salmonella spp. in cooked patty Poultry FARM Domestic and sporadic human salmonellosis Campylobacter jejuni/coli jejuni risk from fresh chicken Risk profile for pathogenic species of Campylobacter in Denmark Risk assessment of C. jejuni in broilers Campylobacter fluoroquinolone resistance Listeria monocytogenes L. monocytogenes hazard identification and hazard characterization in ready--to--eat foods L. monocytogenes exposure assessment in ready--to--eat foods Relative risk of L. monocytogenes in selected ready--to--eat foods L. monocytogenes in EU trade L. monocytogenes in meat balls Enterohaemorrhagic E. coli (EHEC) E. coli O157:H7 E. coli O157:H7 in ground beef Bacillus cereus cereus risk assessment Vibrio parahaemolyticus Public health impact of V. parahaemolyticus in raw molluscan shellfish Mycotoxins Aflatoxins Ochratoxins Other mycotoxins Rotaviruses Viral contamination of shellfish and coastal waters. Future Developments in Microbiological Risk Assessment: International methodology and guidelines Data Training courses and use of resources Microbiological risk assessment support system Glossary of terms used in risk analysis References Internet directory Index

Introduction In every working area, assets are exposed to risk of various harms. In the information technology area, there is risk of damaging or losing resources. Risk assessment is a process that determines what information resources require protection, and it documents potential risks from IT security failures that may cause loss of information confidentiality, integrity, or availability. The purpose of risk assessment is to help management create appropriate strategies and controls for the steering of information assets (BSI Standard 100-1,2,3), (ENISA Regulation). IT resources are tangible assets (such as hardware, equipment, buildings), data, documents, software, users, and intangible resources (reputation, confidence, etc.) Management of the information system (IS) is a component of the company management and makes its inherent part. The planning of the continuity of IS operation and development must be entirely coordinated with the same activities on the company level. Both short-term and long-term strategies must be harmonized within the framework of business, development, changes, and planning. Risk management and its maintenance on an acceptable level is part of the work process and its development. Its basic characteristic must be continuity (Nikolic, 2007). The chosen acceptable risk level after the implementation of particular measures also means a decision on balance referring to costs concerning the achievement of the selected risk level and benefits, i.e., profit of the company. Methodology The methodology of risk assessment implies recognized procedure (Macdonald, 2004), detailed system description, identification of hazards, defining causes of emphasized hazards, risk assessment, measures for risk reduction and mitigation, risk reassessment according to remaining hazards, and conducting measures for maintaining risk at an accepted level. Figure 1 displays the methodology of risk assessment with elements of the risk management system. Risk assessment in the IT area can be conducted by way of various methods. We use the method established and developed by our expert team (Nikolic & Laban 2008). The method was created for the occupational health and safety area, and is successfully applied in the IT area as described in Nikolic and Ruzic-Dimitrijevic (2009). This method enables the achievement of one of the main goals of risk assessment: risk assessment for every employee, workplace, and work environment, i.e., the assessment of all risks. The work environment can be a company, building, floor, or office. It can also be a plant, building site, park, field, or any system, as well as an information system and its components, such as hardware, communication equipment (network), and system software. The workplace in an information system is application software with data as final products, and it can be considered in the same way as in the occupational health and safety area. IT resources are buildings, hardware, communication equipment, software, data, and, of course, people who take part in IT processes. Risk assessment is carried out on more levels (items in the work environment). Software also has several levels--environmental software, operating system, program supported application, and finally a single application--as well as the data used and gained in application executing. Risk assessment of each level involves conducting appropriate protective measures in order to obtain the layered protection. Therefore, the risk assessment of an information system (IS) is conducted through the risk assessment of every application and through the evaluation of the system's state. Risk identification involves the knowledge about the organization (internal and external), as well as earlier experiences about risk issues. The evaluation of risk classifies risk in certain categories (quantitative and/or qualitative) according to which adequate measures are carried out. …