For conducting risk assessments

The third and final aspect of the precautionary principle refers to the burden of proof for improving damage to health and the environment. It is typically regulators who are responsible for conducting risk assessments and ensuring a high level of health and environmental protection. The new EU chemicals policy seeks to reverse the burden of proof , requiring companies to do risk assessments and thereby demonstrate safe use for all chemicals (Section 2.4.1). 

This is frequently the most commonly used tool for conducting risk assessments associated with organizational change management. Many companies just use a basic brainstorming approach to develop the necessary What-If questions used to evaluate the change. However, Tables A.l - A. 13 show one company s prepopulated What-If assessment. Each table addresses a different aspect of process safety for the organization. 

NIST (2012, Sept.). Guide for conducting risk assessments-information security (SP 800-30 Rev.l). Technical report, National Institute of Standards and Technology (NIST). 

FIAM 13] Hamburg Consult Gmbh, SECUR-ED D31.2 Best practices for conducting risk assessments, ISO 31000 2009(E), 2013. 

MAT 09] Matthiass M., Generic Guidelines for Conducting Risk Assessment in Public Transport Networks , COUNTERACT D3a-n, SSP4/2005/TREN/05/FP6/S07.48891, March, 2009. 

Note that in these several examples certain kinds of assumption are used to estimate intakes. In the TCE examples all adults were assumed to consume 2 liters of water each day and were also assumed to weigh 80 kg. Obviously in any population exposed to the contaminated water, it is unlikely that these two assumptions apply with high accuracy to any actual individuals. In fact the assumptions may be quite inaccurate for some individuals, even while they might be reasonably representative, on average, for most. It is in fact not possible to conduct risk assessments without the use of assumptions such as these, and so the individuals that are the subjects of typical risk assessments might be described as generic rather than actual. As will become clear in the later chapters on risk assessment, this type of generic evaluation is appropriate and useful for the purposes of public health protection. 

To assess the potential environmental impact, studies on environmental fate and effects were conducted for a risk assessment. Steger-Hartmann et al. [125] calculated the predicted environmental concentration (PEC) in surface water and compared the resulting concentration of 2 g with the predicted no-effect... 

The Guidelines for Reproductive Toxicity Risk Assessment (US-EPA 1996) discuss the scientific basis for concern about exposure to agents that cause reproductive toxicity and describe the principles and procedures to be followed in conducting risk assessments for reproductive toxicity. They include the female (nonpregnant and pregnant) and male reproductive systems. 

Many countries do not have the expertise and funds to conduct risk assessments of food additives and contaminants. JECFA performs a critical function in providing these risk assessments, and many countries use evaluations from JECFA to establish national regulatory programs for food additives and contaminants. 

The ecological risk assessment was conducted in accordance with the USEPA guidance document Guidelines for Ecological Risk Assessment (USEPA, 1998) . A four-step assessment process was adopted problem formulation, exposure characterization, characterization of ecological effects and risk evaluation. 

From the perspective of the chemist, DQA can be broken down into seven steps shown in Figure 5.3. Similar to the DQO process, the steps may undergo several iterations before the final statement is formulated depending the purpose of data collection, some of these steps may be modified or even omitted. For example, a DQA conducted for hazardous waste disposal data will not be nearly as extensive as the one for a risk assessment project. 

There are many extrapolation methods, of different complexities, and with different purposes and suitabilities for prospective and retrospective risk assessments. A compilation of the methods is insufficient to guide the choice of procedures to use when assessors need to conduct risk assessments. Therefore, a practical and pragmatic guide to extrapolations and their everyday use is provided in the last chapter. It defines a general stepwise approach to identifying the types of extrapolation (matrix and media, (Q)SARs, mixtures, etc.) that are most relevant for an assessment problem, and it defines an overall approach to the assignment of tiers. 

Microcosm and mesocosm studies can be directly designed for the purpose of EQS derivation (e.g., the exposure scenario, communities to be monitored, etc.). Guidance for design and conduction of microcosm and mesocosm studies can be found in the references given for pesticide risk assessment, but OECD has recently published a guideline for a lentic field test that is not focused on pesticides alone (OECD 2006b). 

We fully recognize that many areas of uncertainty are confronted when conducting risk assessments. These include the lack of generally accepted specific assessment techniques. Furthermore, even when risk is assessed there is a lack of a consensus on the absolute limits of acceptable risks. We do feel, however, that there are systematic approaches that can and are being used and, at the minimum, they are directionally correct and can serve as a conceptual framework for regulatory program development. 

Finding 2-4. The requirements for conducting a health and environmental risk assessment for the Newport Chemical Agent Disposal Facility are similar to the state of Indiana requirements for a risk assessment of gaseous emissions from a commercial PCB incinerator. These requirements, which are similar to EPA guidelines for health risk assessments, are a reasonable approach to assessing the health risk posed by the NECDF. 

The approaches described in this chapter are of interest to several audiences in both human health and ecosystem risk assessments, particularly 1) research scientists who are actively involved in developing methods and expanding the knowledge base on how to conduct risk assessments of mixtures, 2) risk assessors who are charged with conducting risk assessments of mixtures, and 3) regulators who are involved in the development of risk assessment procedures and standards for mixtures. 

Riviere et al. (1999) used the isolated perfused porcine skin flap model to study absorption and disposition of JP-8. The percutaneous absorption and cutaneous disposition of topically applied neat Jet-A and JP-8 jet fuels were assessed by monitoring the absorptive flux of the marker components 14C naphthalene and 3H dodecane simultaneously. Absorption of 14C hexadecane was estimated from JP-8. Data were not reported in absolute amounts or concentrations. Instead, the objectives were to determine the relative absorption of the individual marker components from jet fuel, and the effect of a specific jet fuel s composition on the absorption of a specific marker. Having evaluated the absorption of only three of the 228 major nonadditive hydrocarbon constituents of the fuels, the authors stated that this is insufficient information to conduct risk assessments on jet fuels. However, the authors conclusions are informative. Naphthalene penetrated the skin more rapidly than dodecane or hexadecane, but the latter compounds had a larger fraction of the dose deposited in the skin. There were also differences in naphthalene and dodecane absorption and skin deposition between the fuels. These findings reinforce the difficulty of predicting risk for complex mixtures such as jet fuels. 

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