SCIENTIFIC RISK

Risk assessment is carried out to enable a risk management decision to be made. It has been argued that the scientific risk assessment process should be separated from the policy risk management process but it is now widely recognised that this is not possible. The two are intimately linked. 

A decision by the European Parliament to put restrictions on the use of six phthalate plasticisers ignores scientific risk assessments and threatens the basis for Reach, the impending European legislation on chemical strategy. The Strasbourg parliament has voted to ban DEHP, DBP and BBP in children s toys and childcare items. DINP, DIDP and DNOP will be banned from use if the toys or items can be put in the mouth by children. An EU scientific risk assessment said children were not at risk from DINP in toys. A similar study in the US by the Consumer Product Safety Commission reached the same conclusion. European Commission... 

Both PVC and also phthalates were scandalised in public discussion, with the result that in certain individual cases substitution no longer was based on scientific risk analysis alone (Hypothesis 4 cf. above). 

This approach discriminates factors to a large extent in order to distinguish between the single adjustments and to separate best estimates from uncertainty. It should be noted that the ECETOC approach does not mention the establishment of an overall factor and although they mention that all discriminated aspects introduce uncertainties, they do not give guidance on how to account for this. It could also be questioned here whether a nonscientific factor should be discussed in a scientific risk assessment. 

Over the past several decades there have been increasingly strong demands in Europe and the United States that atmospheric chemistry research be directly useful in developing scientific risk assessments and public policies. For example, one component of the EUROTRAC program (European Experiment on Transport and Transformation of Environmentally Relevant Trace Constituents in the Troposphere) ...is expected to assimilate the scientific results from EUROTRAC and present them in a condensed form, together with recommendations where appropriate, so that they are suitable for use by those responsible for environmental planning and management in Europe (EUROTRAC, 1993). 

A number of species have been designated hazardous air pollutants (HAPs) or toxic air contaminants (TACs). Most are directly emitted into the air, but some also have significant secondary sources, i.e., are formed by chemical reactions in air. Furthermore, the ultimate health impacts are determined not only by the emissions and formation of such compounds in air but also by their atmospheric fates. In short, some pollutants react in air to form less toxic species, whereas others form more toxic compounds. Thus, scientific risk assessments of these pollutants require an accurate and complete understanding of their atmospheric chemistry. Some specific examples are discussed in this chapter. 

Some scholars, like Gillette and Krier (1990) and Hornstein (1992), argue that scientific risk analysis fails to recognize important distributional issues. Under some circumstances, for example, it is better to save 2 lives (at a cost of 25 million each) than 1,000 lives (at a cost of 50,000 each). 

For politics and society to come to reasonable decisions about risks in public interest, it is not enough to consider only the results of (scientific) risk assessment. In order to understand the concerns of people affected and various stakeholders, information about both risk perceptions and the further implications of the direct consequences of a risk is needed and should be taken into account by risk management.3... 

On the one hand, all of our interviewees confirmed the official ideal-type distinction between risk assessment and risk management They were of the opinion that SCHER devoted itself to what it was supposed to, that is risk assessment. SCHER reviews scientific Risk Assessment Reports and provides science-based answers to questions from policy-makers. On the other hand, there are several indications of why it can be difficult in practice to maintain a clear distinction between risk assessment and risk management - which basically equates science versus politics and facts versus values. We will illustrate this below. 

These evaluative frames primarily relate to the scientific risk assessment process and the technical ability to manage a risk. By contrast, this book seeks to examine the impact that the different regulatory approaches have on decision-making at national and EU levels. In other words, how a regulatory action varies in the short -and long-term in terms of its (adapted from [258]) ... 

More often than not, stakeholders disagree with each other on scientific risk assessments. While a company may conclude that a chemical does not present an unacceptable risk to human health or the environment, a regulator may identify the need to reduce a risk [473], Consumer or environmental non-governmental organizations (NGO) may push for regulatory action beyond that which regulators deem adequate to reduce a risk. 

Risk assessment is an important step in identifying the depth of the validation effort. Scientifically, risk is the product of the probability of an incident multiplied with the possible impact of the consequences. For this EBRS, aU modules were identified as relevant for GMP. However, for the testing, the functions were classified into three classes — one was direct product influence, e.g., interfaces to the balances and the other was indirect influence on the product e.g., maintenance and... 

Regulatory Program of the Environmental Protection Agency and a Scientific Risk Assessment Case History... 

In essence, therefore, the question of whether or not there is a significant possibility of significant harm must be answered using the most appropriate and scientific risk assessment methods available, although the regulator may use simple guideline values as a short-cut, where this is warranted. However, the use of such criteria as a basis for requiring remediation at a specific site must be withdrawn if a more appropriate assessment shows that there is not, in fact, such a risk. 

Therefore, we distinguish three categories of risks for a practicable and rational risk evaluation (see Fig. 1) the normal area, the intermediate area, and the intolerable area (area of permission) (cf. also Piechowski, 1994). The normal area is characterized by relatively low statistical uncertainty, rather low probability of occurrence, rather low extent of damage, high certainty of assessment, low persistency and ubiquity of risk consequences, and low irreversibility of risk consequences, and the risks iUso have low complexity or empirically proven adequacy. In this case the objective risk dimensions almost correspond to the scientific risk evaluation. For risks in the normal area we follow the recommendations of decision-making analysts who take a neutral risk attitude as a starting point for collective binding decisions. 

As one can see from the aforementioned safety strategies, considerable effort is put into the reduction of any potential risk from the transgenic plant for the environment. In general, the scientific risk can be kept at a minimum, if common sense is applied - in accordance with Thomas Huxley (1825-1895) that Science is simply common sense at its best. For example, protein toxins (for vaccine production) should never be grown in food plants. 

Parliament and Coimcil have decided to exclude from this Directive decaBDE in view of its importance for fire safety and due to an ongoing scientific risk assessment being due to be finalised by the EU in 2003. The Directive will consequently prohibit only octaBDE and pentaBDE from the EU maiket by mid-2004. 

Pharmaceutical QbD is a systematic scientific risk-based holistic and proactive approach to pharmaceutical development that begins with predefined objectives that address product and process understanding. Successful product development relies on consistent application of a proven methodology. The key steps are the same, irrespective of the product or formulation being developed. One proven methodology is described within this chapter. The framework is shown in Fig. 8.19, while a short description of the main steps is given below. 

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