In a press release published on February 23, 2017, the non-governmental organization Center for International Environmental Law (CIEL) informed that a new study released on the same day showed that “most of the information made available by the Sponsorship Testing Programme of the Organisation for Economic Co-operation and Development (OECD) is of little to no value for the regulatory risk assessment of nanomaterials.”
The study was commissioned by CIEL, European Environmental Citizens’ Organisation for Standardisation (ECOS), and the Oeko-Institut, and performed by the Institute of Occupational Medicine (IOM), Singapore. The contractor screened the raw data in the OECD dossiers for 11 nanomaterials (11,500 pages), which were published in 2015 (FPF reported). In addition, for three nanomaterials – fullerenes, single-walled carbon nanotubes, and zinc oxide – all characterization and toxicity data were analyzed in detail. The full data set can be downloaded in excel format.
The results of the IOM study have been summarized in the executive summary and in the context note by CIEL. The main finding was that most of the documents and studies in the dossiers did not provide crucial characterization data on the studied nanomaterial (e.g. size, particle distribution, or surface shape). This makes it “impossible to assess what material was actually tested,” and precludes “any firm statements regarding the nano-specificity of the hazard data published.” In sharp contrast to the evaluation by the European Commission’s Joint Research Centre (JRC) in January 2016, stating that “many existing OECD test guidelines are suitable for nanomaterials” (FPF reported), the IOM study concluded that “given the absence of fundamental information on nanomaterial characteristics, the [OECD] dossiers do not provide evidence of the applicability of existing OECD Test Guidelines to nanomaterials.”
David Azoulay, senior attorney at CIEL, pointed out that “EU policy makers and industry are using the existence of the data to dispel concerns about the potential health and environmental risks of manufactured nanomaterials,” although “in most cases, it is impossible to assess what material was actually tested.”
Doreen Fedrigo, senior policy officer at ECOS, emphasized “the lack of nano-specific information in the dossiers,” and suggested that the test procedures necessary for regulatory risk assessment of nanomaterials should be defined by the “legislation detailing nano-specific information requirements.”
Andreas Hermann of the Oeko-Institut concluded that “serious gaps in current dossiers must be filled with characterization information, preparation protocols, and exposure data.” Until this is done, any decision on the safety of nanomaterials supported by the present OECD dossiers would be “based on faulty and incomplete data.”
Read more
CIEL (February 23, 2017). “11,500-page OECD dossiers on 11 nanomaterials are of “little to no value” in assessing risks.”
CIEL, ECOS, Oeko-Institut (2017). “Analysis of OECD substance testing programme nanomaterial dossiers.”
Riediker, M., et al. (2016) “Executive summary. Analysis of OECD WPMN dossiers regarding the availability of data to evaluate and regulate risk.” IOM (pdf)
Andrew Turley (March 2, 2017). “OECD nanomaterials programme ‘of little value’ for risk assessment.” Chemical Watch
Reference
Riediker, M., et al. (2016). “Full report. Analysis of OECD WPMN dossiers regarding the availability of data to evaluate and regulate risk.” IOM Report 200-00310 (pdf)
