DECISION-MAKING MATRIX

The systems framework proposes to sort chemical uses according to restriction, authorisation (including national permitting schemes) or target-setting (i.e., restricted, authorised, or tolerable uses). To manage this process, a decision-making matrix has been developed that would serve as a ... 

Box 5.5 Exclusion from the decision-making matrix (Step 2) ... 

Information from socio-economic analyses can serve not only to select between alternative risk management measures in the decision-making matrix but can identify the relevant timelines for implementation (e.g., resulting from process change, product reformulation or instillation of pollution abatement technology). In the case of authorisation, REACH specifies that socio-economic data will form a key variable in the identification of suitable alternatives and the period for granting an authorisation before it needs to be reviewed. 

Under REACH, it is anticipated that the level of data generated through registration and evaluation will be sufficient to perform such an analysis. The operability of this prioritisation scheme is tested in Chapter 6 for the same 33 chemicals used to test the decision-making matrix. 

Under the decision-making matrix measures to control occupational exposure at national levels would continue to operate under legislation based on Article 138 of the European Commission Treaty and most environmental emissions would be controlled through legislative frameworks based on Article 175 (see Sections 2.4.3 and 5.3.1). When effective enforcement mandates the control of specific products or processes at the EU level, restriction and authorisation would apply following Article 95 on the internal market. 

Automatic bans for carcinogenic, mutagenic or reprotoxic (CMR) substances following the restrictions procedure under Directive 76/769 have been excluded (step 2) because these will continue to apply under REACH. The result of the risk criteria evaluation for each substance according to the decision-making matrix is shown in Table 6.1 (step 3). Based on the selection procedure detailed in Section 5.3.2, the most suitable regulatory outcome... 

EU risk assessment and the application of the systems framework decision-making matrix both indicate otherwise. The prioritisation method could also isolate several substances that should be given particularly low priorities at the EU level (e.g., BA, butadiene, TCE) which demonstrates some of the inefficiencies of the current regulatory system that could continue under REACH. 

Constructing a decision-making matrix that compiles previous decisions and therefore facilitates comparisons of regulatory outcomes ... 

Analysis of data in literature, given in the list and summarised in the works (Prochazkova 2007b, 2008), showed that the most of procedures corresponds to above mentioned general procedure, and the criticality is mostly determined by scoring, i.e. by decision making matrix (Highway 2002). 

Compliance issues should be prioritized on the basis of the perceived danger to life and property posed by each issue, if noncompliance is continued. A decision-making matrix may help you quantify or weigh the relative importance of each issue to your facility (see Fig. 7). 

Bioassays using cleaned sediment extracts are much more distinctive than bioassays with whole sediment for decision making in a licensing system. This is mainly due to the interference of matrix factors with the assessed endpoint when applying whole sediment instead of cleaned extracts. 

Each process owner requires a defined level of decision authority. This authority level delineates the bounds of decision making granted by the organization to the process owner. Business needs and risk assessment must be incorporated into the design of the decision authority granted to a process owner. Table 6 is an example of a decision authority matrix design for a process owner. It requires cross-functional management support to be effective. 

Initially, when the number of compounds and samples is high, method quality can be balanced by the need for speed. The risk of a potentially incorrect decision based on low-quality bioanalysis is much more manageable in early discovery, particularly because this phase is not regulated but is for decision making and candidate selection purposes only. Expectations for method quality are generally lower for in vitro samples than those from in vivo studies. This is due in part to the amount of effort required to synthesize the relatively modest amount of compound for an in vitro experiment compared to the amount necessary to dose animals and also due to the complexity of the sample matrix, which is much simpler for in vitro samples than in vivo samples such as plasma or tissue. 

The EPA provides further guidance for decision-making in this area when the RPD between two results exceeds 40 percent, the EPA conservatively recommends selecting the higher concentration as a true one (EPA, 1996a). This practice, however, often leads to false positive results and may be the cause of unnecessary site remediation. From a practical perspective, in the absence of matrix interferences for an analyte to be present in the sample the agreement between the two results should be better than 40 percent. If matrix interferences are obvious, a chemist experienced in data interpretation should evaluate the chromatograms and make a decision on the presence or absence of the analyte in the sample. 

As a second step, prior to entering the risk descriptors into the decisionmaking matrix, a potential risk that requires particular regulatory attention needs to be excluded from further decision-making (Figure 5.10). Reasons for excluding potential risks include ... 

If Germany holds political sway on Eastern Member States due to trade8 and Sweden is representative of Nordic states9, this would give 68 votes in favour of the regulatory recommendations (refer to Table 6.2). Because the Netherlands initially proposed a method of decision-making rules broadly similar to the recommendations (i.e., a matrix of hazard and use criteria) it is foreseeable that this country would also vote in favour, bringing a total Council of European Ministers vote count to 73. 

When presented with an ion analysis problem, the worker may use a logical process of decision making to devise a working method for a new type of determination. The method may be based on one already published in the literature or on a standard method published by organizations such as the EPA, AOAC, or ASTM. Or the method may be entirely new, based on analyzing the problem of sample mixture and matrix. 

The above examples illustrate that it is critical to establish short- and long-term stability, as well as freeze-thaw stability data for any matrix that is being investigated (animal or human plasma, urine, tissue extract, etc.) before any firm conclusions can be drawn from a metabolomics study, especially if the data are to be used for drug development decision-making. 

The model did not include adaptive behavior or individual decision making, so it was similar to matrix models, that is, based on demographic rates and further empirical parameters. 

---