International Alliance for NanoEHS Harmonization

Background

There is great interest from many stakeholders, from academia, industry, government, NGO’s and society at large to understand the biological impacts of nanoparticles on human health, and the environment. Various stakeholder organizations around the world are planning, funding, or carrying out early stages of in vitro or in vivo researches to determine the outcome of nanoparicles exposure on known end-points. There is also an awareness that studies may have to be advanced to consider endpoints and methodologies not previously developed within classical toxicology.

Such studies are required to secure the safe and responsible implementation of nanotechnology world-wide, and will require significant investment in human and material resources around the world. Nanoparticles present new challenges for biological researches because of their different sizes, shapes, surfaces (for even a single material) the technical challenges in dispersing and presenting them to cells and animals in a reproducible manner, and their capacity to confound established toxicological tests.

Differences of opinion of the toxicological impacts of nanoparticles have arisen in the literature, and most scientists are increasingly aware of the challenges. Editorial boards of journals, funding agencies and industry around the world stressed the need for reliable scientific information. The importance and urgency of the issues involved is apparent to a broad range of stakeholders.

The International Alliance for NanoEHS Harmonization Response

An interdisciplinary alliance of scientific experts, themselves currently active in all aspects of this arena, drawn from Europe, Japan and the United States has begun the task of investigating the challenge in more detail. Their long term intention is to establish reproducible approaches for study of a broad range of nanoparticle related end-points, as well as considering potential new methodologies. The group is a community of active research scientists and will focus on the practical laboratory issues required for reproducible science as well as the development of novel reproducible research methodologies. It is not intended to have any policy role. However, where desired, it will seek to assist or support the efforts of other agencies, institutions and organizations charged with the more formal role in NanoEHS.

The intended short and medium term objectives and outcomes are,

• Creation of protocols for a limited number of toxicology tests on a small number of representative nanoparticles to enable a ‘round robin’ study in which identical results will be sought. This will involve at least the use of nanomaterials and biologicals, and from a single source and a single set of protocols.

• The implementation a round robin laboratory set of tests based on these protocols

• Ongoing and further development of protocols that take into consideration nanomaterial physicochemical properties and quantitative structure function relationships at the nanobio interface for in vitro and in vivo protocol development

The outcome will be a core set of rationally designed protocols that enable scientists in different locations, coming from several different backgrounds, to obtain identical outcomes. A secondary outcome will be the mutual validation of the participating laboratories in terms of their capacities to implement the required laboratory practices.

• A next phase will involve round robin studies of common nanomaterials, and biological systems, where independent laboratories will choose a different set of agreed approaches to interrogate the biological end-points.

The outcome will reveal to what degree (given validated laboratory practices and fully reproducible results for each study) different approaches currently under discussion differ in their predictions of biological impacts on key end points.

The Approach

This is a peer group of laboratory based scientists that have voluntarily come together to support the development of harmonized procedures in the field. To enable rapid progress with a minimum of high level discussion, research that is consistent with their established research programs has been identified, which can be carried out within this NanoEHS Alliance. The group is open to additional collaborations where circumstances favor this.

Periodic teleconferences are used to plan the research, occasional meetings around the world used to consolidate the plans and report preliminary results.

Ethos

The experience and preliminary protocols from these studies and round-robins will be made available to the scientific community.

It is intended that all of the findings and outcomes of the research of this group will be published freely for the benefit of all stakeholders, and society at large.