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President and Executive Director
It happened quietly: antimicrobial silver is now the first nanomaterial to be governed by irrational and vague fear, with the tragic consequence that new US innovators are shut out of the market by the EPA while previously (to the clampdown) certified foreign suppliers continue to ship without interference. This is a sad time for US innovation, manufacturing and jobs at the hands of an EPA that has chosen not to consider benefits vs. costs. The following is adapted from testimony given to the US International Trade Commission on March 12, 2010.
March 19th, 2010
Precautionary Principle: 1, Innovation Economy: 0
I am concerned that the last ten years of excessive solicitude toward expressed concern (first from *someone who should have known better, then from NGOs including - to be frank - many of the usual technophobic suspects) about the safety of nanotechnology (an issue not even mentioned in the Executive and Technical Summaries of the 1999 International Working Group on Nanotechnologies report) is hampering the commercialization/business development climate for nanotechnology (read: nanostructured materials and devices) companies in the US and Europe. This is not primarily a trade issue, but I believe it will have an important effect on exports and the high-wage manufacturing American jobs they support in one of the most strategic areas of technology and industry in this new century.
The general issue is signs of a trend toward pre-emptive/premature and excessive regulation related to nanotechnology, a category which is much less different from the traditional chemicals/materials industry than many seem to think (in part because of hype generated by nano enthusiasts, to be fair). For a variety of reasons, almost no other technology (e.g. short of nuclear) I can think of has ever been targeted for the level of 'governance' (regulation) that is currently aimed at nanomaterials. This will probably not lead to much of a disadvantage relative to most of Europe (which is just as comfort-addicted and risk-averse as the US), but it certainly will (and already is) relative to Asia and other parts of the world. The burden as always falls hardest on our SMEs, which are also (as the US Trade Representative's recent request for testimony on issues faced by Small and Medium Enterprises states) our most innovative and dynamic companies. And because our large multinational companies frequently benefit by purchasing technologies developed by SMEs or purchasing the SMEs themselves, there can be no denying the importance to the nation of having a vibrant small business sector participating on the frontiers of this important area of innovation.
It is interesting that recent (soon to be published) NSF-funded research on Nanotechnology and Society has shown that, in spite of NGO efforts, the public has NOT been aroused to concern over nanotechnology. So the academic community is ready to 'move on' toward collaboration to exploit its advantages. But damage has already been done at the EPA, which promises to tighten regulation of nanomaterials, and in at least one case has effectively shut down their introduction to the marketplace. A recent article in the New Haven Independent provides a good summary of this trend: http://newhavenindependent.org/index.php/archives/entry/epa_poised_to_crack_down_on_nanotech/
The current specific issue relates to nanosilver (experienced first hand by one of our promising spinout companies with an environmentally superior nanosilver technology held up by a de facto U.S. moratorium on new antimicrobial nanosilver products). A good summary of this situation may be found at http://www.lawbc.com/updates/020810-nano.htm Unfortunately for Oregon and the U.S., Dune Sciences, a small Eugene, OR startup company devoted to green nanotechnology, and which has developed an environmentally and functionally superior nanosilver antimicrobial technology, was told a year ago not to even bother applying for EPA certification pending regulatory clarity which one year later is still nowhere in sight, though knowledgeable experts anticipate very burdensome requirements for pesticide products with 'nano' content.
In the meantime, over 100 previously certified nanosilver products ship, most of which are probably manufactured overseas. Three significant comparable cases are AgActive of Australia (no evidence of required EPA certification), Nanosilver Horizons (US, but we believe product is from South Korea) and Agion of Japan. The situation is patently unfair to new market entrants, which probably have better and safer products. In the case of Dune Sciences, their antimicrobial business is on hold and staff have been let go. With such dramatic loss of time to market, it is not clear that this remains an attractive opportunity any longer. A final irony here is that Dune Sciences, in a show of good citizenship, was one of the few companies that responded to EPA's voluntary Nanomaterials Stewardship Program request for data.
To summarize the SME issue in everyday terms: let's say I want to make a golf club or an article of athletic apparel that incorporates new nano-structured materials in order to achieve breakthrough performance. The prudent thing to do, in light of TSCA (or its regulatory counterparts) and also high uncertainty over how regulation might change (e.g. toward manufacturers having the burden to prove the safety of a new material instead of the federal government having the burden to determine unreasonable risk), is to manufacture this product (imported as an 'article') in China and also source the nanomaterials from China or somewhere else in Asia. This is not for production cost reasons, but for development/regulatory cost and time to market reasons - which are crucial for SMEs and their investors. Considerations such as these may explain at least in part why we are losing so much manufacturing (including advanced/initial manufacturing) in the US, and with it the middle of the job market.
It is all well and good (truly good, and nota bene in Oregon we are doing leadership research in all aspects of green nanotechnology, see http://www.greennano.org for details) to invest in research aimed at understanding the biological effects of nanomaterials - both unintended toxicological effects as well as intended therapeutic or diagnostic effects - but we should not fool ourselves into thinking that this task can be accomplished any time soon, at least not to the satisfaction of those who demand proven safety in all things.
I believe the U.S. and its trading partners would benefit from having practically grounded discussions and aligned policies for trade in advanced materials (including nanomaterials) that emphasize the following principles:
1. The desirability and opportunity for materials innovation to make net positive contributions to human welfare and the environment (this is one of the key points of green nanotechnology).
2. The necessity of good data - which may take quite some time to obtain - in support of regulations.
3. An optimistic and pragmatic view that a permissive approach to small quantities of new materials is likely to do more good (breakthrough innovation) than harm (toxic effects of small amounts). Indeed TSCA as originally written effectively operates this way.
4. Recognition that workplace safety/worker exposure is by far the highest risk scenario at this point, and what should be insisted upon first. Prevention of exposure to materials of unknown effects is a good general practice and not unreasonably difficult to achieve.
A pragmatic approach to consumer and environmental exposure that is informed and calibrated by comparable or near-comparable cases from the past and present is sorely needed. For example, nanosilver has been used in photographic film and paper in large volumes for many years. There has also been significant airborne exposure to ultrafine particulates from vehicle exhaust and other burning.
If you've read this far and are desperate for some common sense, I suggest you read the Silver Nanotechnology Industry Working Group's letter to the EPA: http://nanotech.lawbc.com/uploads/file/Nanosilver-SNWG%20Letter%20to%20SAP%20%20%2800056523%29.PDF
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