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Home > Nanotechnology Columns > Alan Shalleck-NanoClarity > Distinguishing Fact from Story in Nanotechnology Safety

Alan Shalleck
President
NanoClarity LLC

Abstract:
This week is the most important week in the Nanotechnology in three years. The Food and Drug Administration (FDA) has held its first full public meeting on nanotechnology safety and environmental risk, and the Environmental Protection Agency (EPA) has placed a Notice of Rule making re. Nanotech product commercial release requirements in the Congressional Record. These two agencies have the potential to shut down the evolving nanotechnology industry before it begins to grow … an unacceptable prospect.

October 11th, 2006

Distinguishing Fact from Story in Nanotechnology Safety

Distinguishing Fact from Story in Nanotechnology Safety
By
Alan B. Shalleck
October 2006


This week is the most important week in the Nanotechnology in three years. The Food and Drug Administration (FDA) has held its first full public meeting on nanotechnology safety and environmental risk, and the Environmental Protection Agency (EPA) has placed a Notice of Rule making re. Nanotech product commercial release requirements in the Congressional Record. These two agencies have the potential to shut down the evolving nanotechnology industry before it begins to grow … an unacceptable prospect.

Let us hope that the FDA and the EPA leadership understand the positive potential of nanotechnology, will be able to separate fact from story, will not be swayed by the emotional scare mongers and rumor spreaders, and will chose a safe, responsible path of growth-oriented, permissive regulation for nanotechnology in the world. The US nanotech industry needs such a justly designed, but loosely regulated, environment to reach the potential the nano-pundits proclaim. Society stands only to lose from any other approach to nanosafety and to nanotech environmental regulation.

I am not an apologist the nanotech industry. I want this world safe for my kids and their children as much anyone. However, as an MIT trained professional, I have always let analysis of the facts, and of the scientific data, determine my views. Since the potential for safety and environmental damage may, worst case, exist in selected nanotechnology applications, I have immersed myself in the literature and in the multi-issue studies. I have had extensive discussions with those who are rightly concerned that nanotech follow the precept, "first do no harm!" At the conferences this fall, safety and environmental concerns have been primary discussion topics and I have participated in those sessions. I have even reviewed nanotech futures with some of those well meaning but emotional, mutant projecting, publicity seeking, non-profits (like the Woodrow Wilson group, NRDC, ETC Group, Friend of the Earth, etc.) to extract their arguments and data. I have followed a carefully designed informational gathering path to learn all positions and to accumulate all data to date to be fair in my positioning.

The primary FACT about nanotechnology safety today is that safety is not an immediate issue. Everything else is STORY … and regulatory actions are not built around story! At a recent MIT conference on nanotech safety and environmental effects, the scientists on the various panels unanimously concluded that no … I repeat … no short term or long-term harmful effects have been found. "No-current-harmful-effects" was also the conclusion of the speakers at this week's FDA nanotechnology open session. Abroad, the German BFR (government risk assessment agency), the Australian Department of Health and Aging, and other international governmental and NGO groups have argued similarly. There is no immediate emergency. There is no evidence for over regulation. No massive deaths, human disfigurations or extensive harm to the environment are imminent. Despite asking perceptive questions and raising excellent issues for further investigation, the nanotechnology alarmists and panickers are fundamentally wrong to ask for the shut down of the nanotechnology industry. No data anywhere supports their argument.

A strong case exists for continuing the current regulatory approach to safety and environmental impact … with little immediate need for a change to or a toughening of the regulations. There is sufficient time to perform the science and testing necessary to support or change the current regulations. Additional investigatory resources are required to do the required testing and science. The nanotech industry has recommended that the US Government allocate an additional $100 million to further studies and I join those in support. In sum, the experts have argued for a carefully considered, minimally restrictive regulatory environment until it is proven that an alternative is required. It is a well-reasoned approach … mainly because of what the nanotechnology industry itself is doing. Let me explain.

The nanotech industry, for those unaware, is an amazingly responsible self-regulating industry. Nanotech companies are lead by socially conscious scientists, managers and investors. Nanotechnology employs many of the most environmentally and safety oriented professionals in the business and scientific world. They all have wives, children and grandchildren. That alone makes them fundamentally committed to creating and manufacturing safe and environmentally sound nanoproducts. Industry scientists quickly solve any issue relating to any possible safety risks in weeks. (E.g. CNT insolubility two years ago) In addition, nanotechnology supports an industry association, the Nanobusiness Alliance, led by Sean Murdock, with a platform of responsible safety and environmental conservation. Sean, on behalf of the industry, has testified before congress on safety and environmental issues. In sum, nanotechnology worldwide involves many of the most concerned citizens on this planet. Self-regulation of nanosafety and of the nanotech effects on the environment is inherent in their nature and, therefore,, extant throughout the nanotechnological world. That should comfort those who may have been worried.

What most also do not understand is that within the nanotechnology industry there is no, repeat, no economic, or other incentive, to act marginally or irresponsibly. Acting conservatively and responsibly in nanoproducts development is in everyone's self interest. There is no stock market bubble for nanotech companies so little "get rich quick" financial incentive exists for promoters and shysters to do "nanotech" companies or IPO's similar to the dot com era sham fiascos. The missing market bubble removes a major portion of the risk from the industry.

Risk is minimized by source. The majority of the current commercial effort in nanotech is emerging from very large companies such as Dupont, Motorola, Samsung, Toshiba, General Motors, GE, PP&G, L'Oreal, Lancôme, P&G, etc. These are major companies with deep pockets. Large companies follow risk avoidance corporate strategies. Putting untested, unsafe or environmentally risky nanotech products on the market is just not in the cards. Large companies test and retest new nanoproducts for long periods prior to launch. They force proposed finished nanoproducts through rigorous product safety and regulatory internal review committees that have veto power over the marketing of the products, and retain obligations to continue testing approved new nanoproducts for safety long after product launch. In sum, large companies using nanotech in products today have built in protections for the consumer and for society.

The remaining nanotech new products emerge from the small startups or medium sized manufacturers and marketers. Smaller firms have equivalent built in incentives for caution and responsibility. Their risks are financial - because these companies have little economic staying power. A single bad or dangerous product can bankrupt the company or drive its stock into the doldrums. Entrepreneurs and investors live with such financial risks and prudently act to minimize bad product risk. Small company product offerings, in addition, are subject to FDA and EPA regulation and testing requirements. Since scientists and experts can't find any current risk in any of today's nanoproducts, the current regulatory controls must be working. I find that comforting.

In a decade, when we arrive at true nanotechnology and new nanotech molecular creations and nano molecular self-assembly are characteristic of the nanotech industry, additional regulations may be required. I'll address those in a subsequent article. Right now, we have enough open non-molecular manufacturing items to keep investigators busy.

In conclusion, the nanotechnology industry is today under self-regulating control with sufficient Government regulations to keep it moving forward safely and friendly to the environment. Will these be sufficient for the far future? Maybe yes, maybe no. but we have sufficient time properly to research, understand and create controls for future nanotech products. What we need now are not new regulations but additional resources to continue the planned additional studies (amid the visibility open hearings provide) to remove the mythology and fear from nanotechnology's public image. Let's let the regulatory bodies continue along their current paths while the other questions are systematically, factually and calmly answered.


Alan B. Shalleck
President
NanoClarity LLC
www.nanoclarity.com


©2006 NanoClarity LLC all rights reserved

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