(NHI Nanoblog) In a commentary in the journal Nature Nanotechnology, a team of American and European officials discuss the numerous challenges facing the regulation of nanomaterials, and give readers a glimpse of what’s going on behind the scenes.
Officials from the U.S. Environmental Protection Agency, European Commission and the Organisation for Economic Co-operation and Development (known universally as the OECD) write about the difficulties of balancing development and safety and outline areas where they’re working together. The paper includes a standard note that the authors are speaking for themselves, not their agencies.
Nanotechnology involves making medicines and consumer products from the super-properties of super-small particles. It is already in items like bike frames, skin creams and cancer treatments, as well as your laptop and your smartphone.
Shrinking many of these materials to the nanoscale (a nanometer is a billionth of a meter) can change their characteristics, sometimes drastically.
As the market for nano-based applications grows, figuring out what might pose a danger to people and our environment has become a furious effort in laboratories and government offices around the world.
Jeff Morris, the EPA’s national program director for nanotechnology, said in an interview that he and his co-authors were moved to write the piece to refute what he said seems to be a growing impression that Europe is moving ahead of the United States in the effort to understand and, eventually, control and regulate nanomaterials.
Morris, like nearly everyone studying nanomaterials, acknowledges that there’s a lot scientists don’t know about these substances. But the quest for more information, he said, is happening through a major cooperative effort.
The OECD, founded in 1947 to essentially run the U.S.-led Marshall Plan to rebuild post-World War II Europe, is a place where representatives from different countries can come together and brainstorm. Through its nanotechnology working group, Morris said, officials from the U.S., Europe, and non-member nations are aligning their efforts to avoid duplication.
For example, he said, everyone needs information from companies and researchers working in the nano field. Rather than each country asking its own set of questions, Morris said, the partnerships allow discussion of which questions to ask, and for the assignment of those queries to different members.
There might be different interpretations of the information, Morris said, because of legal differences between countries. The Toxic Substance Control Act, or TSCA, is what the EPA is working with, while the European Community’s chemical-regulation guidelines are called REACH, for “registration, evaluation, authorisation and restriction of chemical substances.”
“We’re guardedly optimistic and as the commentary suggests, we have a very good and close relationship with our colleagues in the European Commission on this, and the reason why the OECD venue has been really good is because irrespective of the approach that different countries take toward acquiring information, the challenges we face are the same in terms of what you ask people to provide,” Morris said. “We want to make sure whether data reaches us via REACH or via TSCA that it’s data that’s useful.”
That means making sure the companies and researchers generating the data are following the same testing methods, and coming up with results that can be reproduced in other labs, he said.
As many others have noted, even measuring the level of nanomaterials in a larger substance, let alone figuring out what happens when it goes into water, soil or the air, is a big challenge, Morris said. New tools are in development, and some regulatory agencies, such as California’s Department of Toxic Substances Control, are specifically asking nano producers for their analytical methods.
They key issue, Morris said — again, echoing many in the nano field — is that even within the spectrum that is the nanoscale, size makes a difference. An additional challenge, he said, is that some materials are so small, and therefore are made in such small quantities, that traditional testing and regulatory methods won’t work.
“We have seen some materials where the maximum production threshold is 100 milligrams per year, but they’re high value,” Morris said. “You cannot, obviously, require something with low production volume to do studies that require kilograms to produce … we’re going to have to make sure that the testing regime accommodates the realities of these materials.”
Making those accommodations might mean moving away from animal studies — which often require large amounts of a material — to test-tube experiments that use a tiny bit of the substance.
It’s tough to work in a field with so many unanswered questions, particularly when there are the dual pressures of nurturing scientific and technological development while protecting public safety as much as possible.
But that’s why scientists around the world are pushing for more data — and advising caution where it’s warranted.
“It’s very difficult to say are we behind the curve, ahead of the curve, or on the curve” in terms of environmental and safety issues, Morris said.
“This is still at the beginning, and we’re learning more all the time,” he said.
The TSCA greatly needs an update. According to it, the toxic mineral asbestos is still legal to use in the United States. Asbestos has been linked to mesothelioma, lung cancer and a litany of other diseases. It is time to ban asbestos – http://www.banasbestosnow.com/ - and to update the TSCA. Regards, TM