Incorporating Risk Assessment Research Articles

The Teesside Cancer Family History Service: change management and innovation at cancer network level

The Teesside project took the underlying principle of the Kenilworth model--that people with a family history of cancer should be 'triaged' and signposted to appropriate clinical services--and applied it to a whole clinical cancer network in which inequity was the major driver for change. Unlike the Kenilworth model, the Department of Health/Macmillan Cancer Support-funded pilot project in Teesside embedded genetic risk assessment at secondary care level. The project took a 'bottom up' approach that engaged a wide variety of stakeholder groups and identified key challenges that formed the basis of a clear strategic plan. A number of specialist cancer nurses across the network had independently developed risk assessment roles over preceding years: these roles needed to be redefined prior to the creation of a small team of genetic risk assessment practitioners ('GRAPs'). This innovation challenged existing nursing roles on a local and national level. In turn, however, we were able to introduce a simple, single network-wide referral pathway, reducing workload on both primary care and tumour-specific services; to adopt a standardised genetic risk assessment pathway; and to incorporate risk assessment as a key step in the decision to enroll an individual in a clinical screening programme. Collaborative audit proved to be a useful way of engaging stakeholders and holding their attention throughout the three-year project, proving the value of the project in their terms, and embedding the changes we had made. The keys to success in this project were inclusiveness, transparency and clear strategic management.

Linking Quantitative Exposure Assessment and Risk Management Using the Food Safety Objective Concept: An Example with Listeria monocytogenes in Different Cross-Contamination Scenarios

A practical approach was used to achieve specified food safety objectives (FSOs) by incorporating risk assessment methodology. A series of cross-contamination scenarios at the retail level were evaluated in a spreadsheet and ranked according to their level of risk, and the degree to which they exceeded an FSO for Listeria monocytogenes (100 CFU/g) was determined. Percentiles and analyses of variance were used to identify which scenarios would be most likely not to achieve the FSO. It was also possible to incorporate into the model the effect of additional risk management interventions (e.g., hand washing method) by using “what if” scenarios analysis. The highest risk corresponded to the use of the same gloves to handle contaminated meat and then sliced ham compared with the safer method of using different gloves to handle each product. Nevertheless, in all scenarios bacterial concentrations could be higher than 108 CFU/g. A significant lack of knowledge regarding the transfer rates of L. monocytogenes was revealed, which provided the model with an important uncertainty component. The “what if” scenarios analysis based on the scenario representing handling food with bare hands followed by hand washing (scenario 2) revealed that the hand washing procedure had less impact than expected. This study illustrates the use of scenarios to model the most effective food processes and thus provide risk managers with appropriate information on which to base their decisions.

Life cycle impact assessment: a challenge for risk analysts.

Modern technology, together with an advanced economy, can provide a good or service in myriad ways, giving us choices on what to produce and how to produce it. To make those choices more intelligently, society needs to know not only the market price of each alternative, but the associated health and environmental consequences. A fair comparison requires evaluating the consequences across the whole "life cycle"--from the extraction of raw materials and processing to manufacture/construction, use, and end-of-life--of each alternative. Focusing on only one stage (e.g., manufacture) of the life cycle is often misleading. Unfortunately, analysts and researchers still have only rudimentary tools to quantify the materials and energy inputs and the resulting damage to health and the environment. Life cycle assessment (LCA) provides an overall framework for identifying and evaluating these implications. Since the 1960s, considerable progress has been made in developing methods for LCA, especially in characterizing, qualitatively and quantitatively, environmental discharges. However, few of these analyses have attempted to assess the quantitative impact on the environment and health of material inputs and environmental discharges Risk analysis and LCA are connected closely. While risk analysis has characterized and quantified the health risks of exposure to a toxicant, the policy implications have not been clear. Inferring that an occupational or public health exposure carries a nontrivial risk is only the first step in formulating a policy response. A broader framework, including LCA, is needed to see which response is likely to lower the risk without creating high risks elsewhere. Even more important, LCA has floundered at the stage of translating an inventory of environmental discharges into estimates of impact on health and the environment. Without the impact analysis, policymakers must revert to some simple rule, such as that all discharges, regardless of which chemical, which medium, and where they are discharged, are equally toxic. Thus, risk analysts should seek LCA guidance in translating a risk analysis into policy conclusions or even advice to those at risk. LCA needs the help of RA to go beyond simplistic assumptions about the implications of a discharge inventory. We demonstrate the need and rationale for LCA, present a brief history of LCA, present examples of the application of this tool, note the limitations of LCA models, and present several methods for incorporating risk assessment into LCA. However, we warn the reader not to expect too much. A comprehensive comparison of the health and environmental implications of alternatives is beyond the state of the art. LCA is currently not able to provide risk analysts with detailed information on the chemical form and location of the environmental discharges that would allow detailed estimation of the risks to individuals due to toxicants. For example, a challenge for risk analysts is to estimate health and other risks where the location and chemical speciation are not characterized precisely. Providing valuable information to decisionmakers requires advances in both LCA and risk analysis. These two disciplines should be closely linked, since each has much to contribute to the other.

Clinical Risk Assessment for People with Learning Disabilities Who Offend

The England and Wales National Health Service (NHS) Executive's guidance on the discharge of mentally disordered people, including those with learning disabilities, requires that risk assessment is a component part of the Care Programme Approach (CPA). The guidance indicates that whenever possible, risk assessments should be carried out systematically using a standardised approach. For a number of reasons, practitioners are resistant to moving away from reliance on clinical judgements when making their assessments. This paper explores the issues underlying this tension. A solution is offered to the difficulty clinicians often experience in incorporating risk assessment tools into their clinical practice. A case example is given to illustrate how clinical assessments of offenders with learning disabilities can be utilised to estimate the risks presented. By demonstrating this procedure, a protocol for reaching clinically defensible decisions about the risks presented by clients is described, which also allows for the targeting of priority therapeutic and management interventions.

Risk-based Decision Process for Arsenic in Soils: Implications of Conservative Protocols

Making defensible risk-based decisions is a complex process that incorporates risk assessment into a risk management framework. Many site investigations require additional study, negotiations and/or actions for arsenic detected in soil samples, in many cases where no process related sources are identified and no other chemicals of concern are identified. Regulatory agencies develop guidance to standardize approaches to risk-based site investigations that focus on achieving “safe” concentrations. For arsenic, the action level is frequently in the “gray region”, a U.S. Environmental Protection Agency (USEPA) term associated with a region of high uncertainty for risk management decisions in the “decision performance curve” associated with the data quality objective (DQO) process. Recognizing the conservative nature of the risk-based screening value for arsenic, approaches to enforce this level (or proof of comparability to natural background) may have numerous consequences including ineffective use of resources, stigmas on properties or actions at industrial or hazardous sites that are inconsistent with their regional setting. Florida has developed regulations and guidance on investigation of brownfield sites and has supported a study by the University of Florida (UF) to evaluate natural background concentrations in Florida soils. This paper discusses the sources of uncertainty near the soil cleanup target levels (SCTLs) in the Florida decision-making framework.

Technical and Policy Challenges in Developing and Implementing Risk-Based Environmental Regulations

The reform in environmental regulations being considered at both federal and state levels is intended to enhance the value and effectiveness of a rule by incorporating risk assessment and cost benefit analysis in the rule making process or regulatory implementation. Although a risk based approach may not provide a panacea to all environmental problem solving, it offers some obvious advantages over the status quo. In particular, it establishes a scientifically defensible basis for evaluating the trade off between risks, costs and benefits in making prudent environmental decisions and developing effective regulatory policies. This paper presents a conceptual framework for risk reduction, summarizes the current status in risk-based legislation at the federal level, provides examples of how various states are using risk based approaches in their regulatory programs, addresses aspects of technical and policy challenges in rule making and other policy and enforcement decisions and provides suggestions for meeting these challenges.

Incorporating risk assessment and risk management into public policies on genetically modified finfish and shellfish

Genetically modified finfish and shellfish pose economic benefits to aquaculture, but also pose ecological and genetic risks to ecosystems receiving such organisms. Realization of benefits with minimization of risks posed by a new technology can be addressed through the processes of risk assessment and risk management. Public policies adopted by individual countries will reflect differences in the outcome of risk assessment and risk management processes resulting from differences among the receiving ecosystems and sets of human values at issue. A number of countries and international institutions have begun development of policies for oversight of genetically modified aquatic organisms. In the United States, a working group commissioned by the U.S. Department of Agriculture incorporated risk assessment and risk management principles into draft performance standards for safely conducting research with genetically modified finfish and shellfish. The performance standards address research with a broad range of aquatic GMOs, and compliance is intended to be voluntary. In contrast, the Canadian policy mandates adherence to specified guidelines for experiments with transgenic aquatic organisms; establishment as national policy is expected soon. Based upon the recently-adopted Gene Technology Act, Norwegian policy does not preclude use of genetically engineered aquatic organisms in the aquaculture industry, but the Norwegian government seems unlikely to support such use. Policies on aquatic GMOs have been adopted by leading international institutions concerned with fisheries management or aquaculture. The philosophy and technical content of oversight policies have important implications for scientists involved in research with aquatic GMOs.

A Process for Incorporating Comparative Risk into Environmental Policymaking in Louisiana

The goal of Louisiana's 1990–1991 comparative risk project, also called the Louisiana Environmental Action Plan (LEAP), was to incorporate risk assessment into state environmental planning and policymaking. Scientists, government officials, and citizens were brought together to estimate the relative risk to human health, natural resources, and quality of life posed by 33 selected environmental issues. The issues were then ranked according to their relative estimated risks. It was hoped that this ranking of “comparative risks” would enable state policymakers to target the most important environmental problems and allocate scarce public resources more rationally and efficiently. As a result of the project, the governor issued an Executive Order forming a permanent Public Advisory Committee to continue this type of comparative risk assessment in Louisiana.

Early detection program for prostate cancer: results and identification of high-risk patient population

Three hundred sixty-two men underwent transrectal ultrasound of the prostate (TRUS), digital rectal examination (DRE), and serum prostate-specific antigen (PSA) determination as part of an early detection program for prostate cancer. Thirty-seven (10%) cancers were detected. DRE had the highest sensitivity and specificity, 89 percent and 84 percent, respectively. TRUS and PSA had comparable sensitivities (84% and 81%) and specificities (82% and 82%). The positive predictive values of DRE, TRUS, and PSA determination were 39 percent, 35 percent, and 33 percent, respectively. We found a cancer detection rate of 16 percent among patients with symptoms of bladder outlet obstruction and 5 percent in patients without these symptoms. The detection rate was 36 percent for physician-referred patients and 3 percent for self-referred patients. This suggests to us that at the present time the best utilization of medical resources to increase prostate cancer detection is to educate men to have annual medical evaluations by primary-care physicians who are encouraged to incorporate risk assessment and screening DRE as part of their routine practice. Any man with either abnormal findings on examination or increased risk should be referred to a urologist for further evaluation.

Risk assessment and legislation

The use of risk analysis and risk assessment in the legislative process is a recent phenomenon. Both risk assessment and the legislative process are uncertain, seemingly irrational, unpredictable and generally to be avoided. The use of risk analysis has been found useful in improving the management of risk in society and in particular Improving the framework for discussion and decision-making. The paper reviews the characteristics of both risk and legislation and provides some guidelines for incorporating risk assessment in an efficient and effective way.

Incorporating Risk Assessment and Benefit‐Cost Analysis in Environmental Management1

Using data from interviews with a key set of individuals at the U.S. Environmental Protection Agency, this study examines intraagency views about the incorporation of risk assessment and benefit‐cost analysis in environment management.

Risk assessment and legislation

The use of risk analysis and risk assessment in the legislative process is a recent phenomenon. Both risk assessment and the legislative process are uncertain, seemingly irrational, unpredictable and generally to be avoided. The use of risk analysis has been found useful in improving the management of risk in society and in particular Improving the framework for discussion and decision-making. The paper reviews the characteristics of both risk and legislation and provides some guidelines for incorporating risk assessment in an efficient and effective way.

The Use of Risk Assessment During Selection of Off-Site Response Actions

This paper addresses the need for incorporating risk assessment procedures into the decision making for off-site response actions under the Comprehensive Environmental Response, Compensation and Liability Act of 1980 (CERCLA or "Superfund") and the Resource Conservation and Recovery Act (RCRA). Differences in regulatory approaches of the CERCLA and RCRA programs as well as inherent deficiencies in implementation of RCRA have led to problems from past off-site responses. EPA's 1985 "Procedures for Planning and Implementing Off-Site Response Actions" do not provide for adequate risk assessment practices to overcome these historical deficiences. EPA can act as a role model for industry and engender public support by selecting the best off-site facilities. Developing guidance under CERCLA and RCRA addresses the need for risk assessments in the regulation of hazardous waste. The so-called Off-Site Policy should articulate a strategy for use of risk assessment during implementation of off-site responses to maximize the probability of selecting RCRA facilities that pose the least short- and long-term risks.