European center for the validation

The European Center for the Validation of Alternative Methods (ECVAM) uses and evaluates toxicogenomics, among other methods, e.g., in its carcinogenicity program (ECVAM 2007). 

ECVAM European Center for the Validation of Alternative Methods... 

Last but not least there is an urgent need to "harmonize" or "standardize" all these procedures so that improved interlaboratory comparisons can be achieved. Such procedures include, cell isolation, growth substrates, cell culture media including the mode of medium application. A first initiative in this direction has been taken by ECVAM (European Center for the Validation of Alternative Methods, a section of the European Commission Institute for Health and Consumer Protection) by founding a task force dealing with the creation of guidelines for "Good Cell Culture Practice" [247, 248]. 

The US Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT) has only a 90-day review period to issue a decision on Premanufacture Notices filed under the TSCA for any new compound to be manufactured or imported. The availability of inexpensive approaches for reliable assessment of hazard to environment and human health could be of immense value to OPPT. Likewise agencies such as the European Center for the Validation of Alternative Methods (ECVAM) aim to promote the scientific and regulatory acceptance of alternative methods... which reduce, refine, or replace the use of laboratory animals [5]. 

ECETOC. 2007b. European Centre for Ecotoxicology and Toxicology of Chemicals (publications) website http /www.ecetoc.org/Content/Default.asp PagelD = 21 ECVAM. 2007. European Center for Validation of Alternative Methods website. http /ecvam.jrc.it/index.htm EU. 2006. The DG Environment REACH website. http /ec.europa.eu/environment/chemicals/reach EU. 2007. European Commision, Research Science and Society website The role of ethics in EU research. 

Right now, in Europe, there are three validated in vitro assays aimed at evaluating embryotoxicity (teratogenicity) potential. Three of these assays were submitted to extensive intra- and interlaboratory validations lead by the European Center for Validation of Alternative Methods (ECVAM) (3) ... 

QSARs are deemed potentially applicable, especially if the QSAR is extensively validated (see critical reviews of available QSARs for ecotoxicology European Center for Ecotoxicology and Toxicology of Chemicals [ECETOC] 1998 Comber et al. 2003). 

The issues of method validation and assessment of measurement uncertainty in the determination of potentially toxic trace elements in rice are of permanent interest for the scientific community. In this context, the sources of uncertainty associated with the determination of Cd, Cu, Pb, and Zn have been recently estimated in rice through an interlaboratory comparison [30]. Four Brazilian laboratories participated in the proficiency test. The analytical technique used were FAAS, ET-AAS, and ICP-AES. The rice samples were supplied by the Institute for Reference Materials and Measurements (IRMM), Joint Research Center of the European Commission, within the scope of the interlaboratory comparison International Measurement Evaluation Programme (IMEP) 19 Trace Elements in Rice (see also Chapter 7 in this book). Three out of the four laboratories reported values close to the reference values. It was emphasized that, in order to establish a reliable uncertainty budget, all significant sources of uncertainty should be identified. 

Several European centers were engaged in implementing GMP standards for the preparation of " Tc radiopharmaceuticals in nuclear medicine, and thus have contributed to establish a protocol for analytical procedures, which can validate the performance of generator systems from different manufacturers and assure the quality of short-lived generator eluates. The protocol is presented in Appendix A1 of this chapter. 

Quality control is of the utmost importance in the case of mineral analyses because of the low concentrations of the elements normally found in foods and the ubiquitous presence of significant levels of many of them in the environment. In addition to the standard techniques of working in a clean laboratory to reduce the potential for accidental contamination to a minimum, it is essential that procedures be validated and results checked against appropriate certified reference materials (CRMs). CRMs for most of the trace and other minerals of interest in foods are available from international reference centers such as the Community Bureau of Reference of the European Union, the National Institute of Standards and Technology of the United States, and the International Atomic Energy Agency in Vienna. 

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