PARIS--The Organization for Economic Cooperation and Development
plans to publish “in the next four to five weeks” new
draft guidance on the preparation of samples used for safety testing
of manufactured nanomaterials, an OECD official told BNA Nov. 2.
The new document, “Preliminary Guidance Notes on Sample
Preparation and Dose Symmetry for the Safety Testing of Manufactured
Nanomaterials,” addresses “one of the most problematic
areas that people have had to think about not just in safety testing
but in testing of nanomaterials in general,” said Peter Kearns,
principal administrator at OECD's environment directorate.
Kearns said the OECD Working Party on Manufactured Nanomaterials,
which has been working on the notes “for quite some time,”
agreed to publish the document during its sixth meeting, held Oct.
28-30 at OECD headquarters in Paris.
That meeting brought together 110 participants from 30 delegations,
including 22 of OECD's 30 member countries, the European Commission,
the International Organization for Standardization, and delegations
from United Nations agencies, as well as non-OECD countries South
Africa, Thailand, business and industry, and a representative for
environmental nongovernmental organizations.
The meeting discussed the Working Party's 2009-2012 schedule,
including plans to participate in a U.N. regional education program
under the Strategic Approach to International Chemicals Management
(SAICM) framework, starting in China in November.
The group also discussed progress in its sponsorship program for
testing of manufactured nanomaterials and a database of nanomaterials
safety testing projects, among other things, Kearns
said.
Unexpected Results.
Kearns said using traditional bulk chemical test methods with
nanomaterials can lead to unexpected results. “Materials tend to
agglomerate or will attach themselves to other things that are in the
[test] medium. So there is always the possibility that people are not
testing the thing that they thought they were testing,” he
said.
Consequently, sample preparations are critical when doing safety
testing, thus the need for the new guidelines.
The OECD expects experts around the world to comment on the
document, and after about a year, a new draft will likely be issued.
“It's a tricky issue, in the technical sense, so we want to get
as much input as possible from people involved in this testing
globally,” he said.
Kearns said the Working Party will also be expanding its exposure
assessment program, which until now mainly dealt with occupational
exposure.
“The Working Party has moved very quickly in this area, and
that particular project will now be looking at environmental exposure
and consumer exposure. That's a new departure,” he
said.
U.N. Collaboration.
Kearns said the OECD working group agreed during its recent meeting
to collaborate with the U.N. Institute for Training and Research on
regional events on nanotechnology, under the SAICM framework, which is
managed by the U.N. Environment Program.
Following the Geneva meeting of the International Conference on
Chemicals Management in May, the first since parties agreed to the
SAICM in 2006, UNEP plans to hold regional meetings on nanotechnology,
in central and eastern Europe, Africa, and other places.
SAICM aims to help ensure that by 2020 chemicals are made and used
in ways that do not harm human health or the environment.
Kearns said OECD will be explaining human health and environmental
safety aspects of nanotechnology at the regional meetings. “We
will be explaining the kind of work we've been doing and the kind of
guidance documents that we've developed,” he said. The first
such event will be Nov. 27 in Beijing, for the Asia Pacific
region.
The working group also assessed the OECD database on environmental
health and human safety research projects related to nanotechnology,
which was launched in April, he said.
The database has 750 to 800 records and identifies protocols used
by safety testing projects.
“This allows comparing across these different types of
testing projects. Knowing [whether] they have been using standardized
protocols or something different and novel makes a difference in the
way that you look at the data that comes from those projects,”
Kearns said.
Sponsorship Program.
In 2007, the Working Party launched a so-called sponsorship program
involving OECD members, some nonmember countries, and other
stakeholders to pool expertise and fund safety testing of a priority
list of 14 manufactured nanomaterials that are in, or close to,
commerce, and a list of endpoints to be tested.
Kearns said that “the sponsorship program is easily the
biggest chunk of work that the working party does.”
During its recent meeting, the working group took stock of where
various delegations are in the sponsorship program and determined the
program is progressing surprisingly well, Kearns said.
“Of the 14 nanomaterials we're testing, some, like carbon
nanotubes and fullerenes, got off to a very quick start and are much
more advanced than some of the others. For example, titanium dioxide
took a longer time to put together the different delegations and
experts who would be working on them,” he said.
One or two, dendrimers for example, are still in the early stages,
but generally the program has encountered few obstacles, he said.
The working party's next general meeting will be in May next year,
but it will likely meet again before that to compare lessons learned
across the different testing programs to help move forward more
quickly, he said.
By Rick Mitchell
More information on OECD's Safety of Manufactured Nanomaterials
project is available at
http://www.oecd.org/topic/0,3373,en_2649_37015404_1_1_1_1_37465,00.html
Copyright 2009, The Bureau of National Affairs, Inc.