Impact assessments method development

Presented as an overview of the State of Oregon s unique approach to particulate control strategy development, this review was prepared to provide those responsible for airshed management with new information on source impact assessment methods. (This material is available in the form of an audio-visual program suitable for presentation before public, regulatory or private Interest groups). 

With the Life Cycle Assessment method developed from the late 1980s of the twentieth century, it has become possible to assess the overall envirOTunental impacts caused by products or product systems. With the help of LCA, parts, components, complete products as well as technologies and processes of any t)q)e, material, purpose and in any industry can be investigated and possibilities for an ecological optimization can be identified. 

Chapter 5 describes simplified methods of estimating airborne pollutant concentration distributions associated with stationary emission sources. There are sophisticated models available to predict and to assist in evaluating the impact of pollutants on the environment and to sensitive receptors such as populated areas. In this chapter we will explore the basic principles behind dispersion models and then apply a simplified model that has been developed by EPA to analyzing air dispersion problems. There are practice and study problems at the end of this chapter. A screening model for air dispersion impact assessments called SCREEN, developed by USEPA is highlighted in this chapter, and the reader is provided with details on how to download the software and apply it. 

Accurate, precise and sensitive analytical methods are important to the collection of data needed for regulatory decisions about pesticide registration. This article describes the various components of analytical method development, validation and implementation that affect the collection of pesticide residue distribution data for regulatory assessment of environmental fate and water quality impacts. Included in this discussion are both the technical needs of analytical methods and the attributes of study design and sample collection needed to develop data that are useful for regulatory purposes. 

Gralinski, M.R. (2000) The assessment of potential for QT interval prolongation with new pharmaceuticals impact on drug development Journal of Pharmacological and Toxicological Methods, 43, 91-99. 

Partial or complete re-validation is another precedented approach to method transfer. Those variables described in method validation guidance documents (ICH Q2B, 1996 USP, 2012c) that are likely to be impacted by method transfer, should be assessed and documented (transfer or validation protocol). Agut et al. (2011) indicated that, in the changing industry model with the increased outsourcing of R and D activities (alliances, outsourcing, etc.), method re-validation may constitute, in some cases, an efficient approach when the transfer is performed from the Analytical Development Laboratory of an external partner who does not share exactly the same environment (validation standards, analytical culture or traditions , equipment, etc.). ... 

The number of analytical methods developed for the study of the distribution of metal- and metalloid-containing species in the last decade has been impressive. However, a majority of these are as yet to be applied to real biological materials. With the greater appreciation of the pre- and post-sampling factors that influence chemical speciation, and the development of appropriate quality control materials the results of these studies will become more reliable. Consequently, the use of chemical speciation data will become indispensable to accurate environmental impact assessment, and to our understanding of the roles that metals and metalloids play in biological systems. 

There are many concepts in use for the assessment of risks or impacts of chemical mixtures, both for human and ecological risk assessment. Many of these concepts are identical or similar in both disciplines, for example, whole mixture tests, (partial) mixture characterization, mixture fractionation, and the concepts of CA and RA (or I A). The regulatory application and implementation of bioassays for uncharacterized whole mixtures is typical for the field of ecological risk assessment. The human field is leading in the development and application of process-based mixture models such as PBTK and BRN models and qualitative binary weight-of-evidence (BINWOE) methods. Mixture assessment methods from human and ecological problem definition contexts should be further compared, and the comparison results should be used to improve methods. 

A fourth experiment would be an evaluation of precision and recovery at one to four concentration levels (n — 6 to 24 plus a recovery standard), plus recovery of an internal standard (n — 3 plus recovery standard). Therefore, as a minimal method development exercise, 60—70 spiked samples would be prepared and extracted within 1 day. The experiments need to be performed sequentially because the results from each will impact how subsequent experiments are designed. Selectivity is assessed through the course of the method development. The analytical chemist with access to API LC/MS/MS will spend less time on solid-phase extraction selectivity development. 

The methodology of impact assessment for some environmental impacts is still under scientific development. This applies especially for the toxicity potential (HTP, AETP, TEPT). The impact models and methods for these and their use in decision making has partly been recalled recently also by developers of the methods... 

First, governments, in a national or international context, should carefully assess, before developing and implementing environmental policies, the need for such policies, the potential methods of achievement, and their impact on industry. 

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