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Phase 3: Interlaboratory Studies

METHODS DEVELOPMENT AND REFINEMENT

Interlaboratory studies will be conducted in Phase 3 to develop methodologies identified in Phase 2. If we are successful, the resultant methods will be widely used to assess the potential for release and feed into exposure and subsequent risk evaluations. The methods will also be useful to guide design, development, and testing of nanomaterial products. Ideally, these methods would be the basis of consensus documentary standards from standards development organizations.

CURRENT FOCUS

 
Phase 3 of the project will conduct testing and methods development using an interlaboratory testing approach, in which US and Canadian government, industry, and academic laboratories are convened using a “cooperative research and development agreement” approach often used by US government agencies to enable technology transfer between public and private sectors.
 
There are two stages of test methods for the detection and characterization MWCNTs released from products and articles by various means such as abrasion and incineration. The first stage, Tier 1, involves the use of “master batches” of products designed to have varying release potentials of MWCNTs from low to high that represent a range of products used in consumer articles. The second stage, Tier 2, involves the detection and characterization of released MWCNTs from actual consumer articles.
 

FREQUENTLY ASKED QUESTIONS

Answers to frequently asked questions about the NanoRelease project are available here​.

TIER 1 AND TIER 2 TESTING

 
 
For purposes of discussion here, an “article” is something that is made and sold in commerce. In common parlance this is often referred to a “finished product”.
 
The legal definition an “article” in the U.S. Toxic Substances Control Act is:
“a manufactured item (1) which is formed to a specific shape or design during manufacture, (2) which has end-use function(s) depending in whole or in part upon its shape or design during end use, and (3) which has either no change of chemical composition during its end use or only those changes of composition that have no commercial purpose separate from that of an article, and that results from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles.”
In terms of the value chain, U.S. regulators refer to the precursor materials that are made into articles as either “chemical substances” or “products”. For example, carbon nanotubes can be sold in a free form (the powder in the above diagram) for research purposes and this would be referred to as a product. Similarly, carbon nanotubes can be mixed with plastic (the pellets in the above diagram) and sold as a “master batch” to subsequent manufacturers and this master batch would also be called a product in U.S. regulatory terms. The subsequent manufacturers would use the master batch to mix with other materials to make an “intermediate” product or “pre-preg” which can then be sold again or made into a finished product, these would be called articles.
 
Image source: Left and middle images courtesy of Nanocyl with permission.

​​NANORELEASE PROJECT

Phase 1: Nanomaterial Selection (completed)
Phase 2: Methods Evaluation (in progress)
Phase 3: Interlaboratory Studies (late 2012)
RESOURCES
 
CONTACT US
Richard Canady, PhD, DABT
Director, RSIA
NanoRelease@ilsi.org
 
WHAT IS RSIA?
 
This project was undertaken with the financial support of the Government of Canada through the Federal Department of the Environment.

Ce project a été réalisé avec l'appui financier du Gouvernement du Canada agissant par l'entremise du ministère fédéral de l'Environnement.​​