Risk assessment, analytical method

Ranky, R G., A generic, analytical method to assess process-related risk with case studies, The Project Management Institute (PMI) Risk SIG and the Institute for International Research (HR), paper presented at the Annual US National Project Risk Symposium, Houston, TX, May 22-May 26, 2006. 

Reliable residue data are generated during the development of an a.i. to support the assessment of the consumer risk (residue data and toxicological data) and the impact on the environment (fate and behavior, efficacy and ecotoxicological data). It is critical that these analytical methods are reliably validated. In the guidance document SANCO/3029/99 rev. 4 (11/07/00), harmonized requirements for the residue analytical method are described. Validated analytical methods are required for the following studies ... 

Analytical methods must be capable of determining the a.i. and/or relevant metabolites in the presence of the sample matrix. Where the sample contains more than one isomer, analog, etc., of an a.i. or relevant metabolite, the method should distinguish between individual isomers/analogues where this is necessary for carrying out risk assessment. 

The definitions of method detection and quantification limits should be reliable and applicable to a variety of extraction procedures and analytical methods. The issue is of particular importance to the US Environmental Protection Agency (EPA) and also pesticide regulatory and health agencies around the world in risk assessment. The critical question central to risk assessment is assessing the risk posed to a human being from the consumption of foods treated with pesticides, when the amount of the residue present in the food product is reported nondetect (ND) or no detectable residues . 

As probabilistic exposure and risk assessment methods are developed and become more frequently used for environmental fate and effects assessment, OPP increasingly needs distributions of environmental fate values rather than single point estimates, and quantitation of error and uncertainty in measurements. Probabilistic models currently being developed by the OPP require distributions of environmental fate and effects parameters either by measurement, extrapolation or a combination of the two. The models predictions will allow regulators to base decisions on the likelihood and magnitude of exposure and effects for a range of conditions which vary both spatially and temporally, rather than in a specific environment under static conditions. This increased need for basic data on environmental fate may increase data collection and drive development of less costly and more precise analytical methods. 

It is a regulatory requirement that analytical methods be developed to determine residues of concern in crops, feed, and food commodities as well as environmental samples (air, soil, and water). Methods for crops, feed, and food commodities are required for enforcement purposes but are also needed for a variety of other purposes, such as gathering monitoring data for risk assessment. For nearly any purpose, the methods must be robust, that is, when used by different analysts in several laboratories, they should provide reproducibly similar results. 

Among the more important design considerations of the task forces has been the lowering of detection limits of analytical methods to reasonable and attainable levels. These lower levels have resulted in lower default values (non-detectable levels) for use in risk assessments. Conversely,... 

From the point of view of risk analysis assessment, it might be needed both analytical methods as well as thorough toxicity assays and biological methods as it is not possible to detect all the compounds present in real samples. This is especially interesting in the case when, for example, a single sludge sample is toxic just due to a compound present at very low concentration. Combination of techniques is... 

SVA Methodologies There are several SVA techniques and methods available to the industry, all of which share common elements. The following is a list of some available SVA methodologies published by various governments, private, and trade andprofessional organizations. Some are merely chapters or sections of documents that address security or risk assessment/risk management in broader terms. Some are SVA or VA publications by themselves. Some of these methods are complete, systematic analytical techniques, and others are mere checklists. 

CPE XI returned to Cairo, Egypt in 1997, and papers and posters were presented on adsorption, analytical methods, chemical/biological/treatment, groundwater studies, ion exchange, modeling, risk assessment, waste minimization and treatment, and for the first time, ISO 14001, which focuses on environmental management and quality systems. 

The sustainable management of sediments, in addition to water, soil and sludge environmental matrices, in relation to surfactant regulations, is also an important and relevant issue. The US EPA has recently shown concern regarding the levels of surfactants in sediments and has thus released a Draft Contaminated Sediment Science Plan. In this draft, recommendations for the development of analytical methods and evaluations of the toxicity and risk assessment of Emerging endocrine disrupters like APEOs and their metabolites in sediment samples are outlined. 

Research interest in POPs appears to be a relatively recent phenomenon with a dramatic increase in the POPs related publications since 1993. Despite a significant number of research studies most of this is limited to studies of field exposure and analytical methods with few studies on risk assessment, alternatives to POPs or management and disposal techniques. Some participants pointed out that there have been few studies in China assessing the long-term effects of POPs on people or critical ecosystems, studies that would be particularly useful for decisionmakers and for increasing public awareness of the problems posed by such chemicals. 

Thus, as often occurs in petroleum science (Speight, 1999), the definition of total petroleum hydrocarbons depends on the analytical method used because the total petroleum hydrocarbons measurement is the total concentration of the hydrocarbons extracted and measured by a particular method. The same sample analyzed by different methods may produce different values. For this reason, it is important to know exactly how each determination is made since interpretation of the results depends on understanding the capabilities and limitations of the method. If used indiscriminately, measurement of the total petroleum hydrocarbons in a sample can be misleading, leading to an inaccurate assessment of risk. 

In 1958, in response to the increased awareness that chemicals can cause cancer, the US Congress passed the Delaney clause, which prohibited the addition to the food supply of any substance known to cause cancer in animals or humans. Compared with today s standards, the analytical methods to detect a potentially harmful substance were very poor. As the analytical methods improved, it became apparent that the food supply had low levels of substances that were known to cause cancer in either animals or humans. The obvious question was Is a small amount of a substance safe to consume. This question in turn raised many others about how to interpret data or extrapolate data to very low doses. The 1970s saw a flourishing of activity to develop and refine risk assessment methodologies. 

---