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On February 27, 2007, DuPont and Environmental Defense released a draft framework of a nanotechnology materials risk assessment procedure for comment. DuPont and Environmental Defense should be commended for a most comprehensive effort, but at the same time recognize that although many of the tests included are of universal necessity, the rest will stratify the industry into those that can afford to follow the guidelines and the smaller companies that will find commercializing their inventions inhibited by imposing the draft. Potentially, this draft can be the nanotech version of Sarbanes-Oxley - the accounting law that is so burdensome for small companies. An alternative is needed.
March 16th, 2007
A Nanotech Environmental and Safety Proposal
A Nanotech Environmental and Safety Proposal
Alan B. Shalleck
March 11, 2007
On February 27, 2007, DuPont and Environmental Defense released to the general public a draft framework of a nanotechnology materials risk assessment procedure for comment prior to recommending that it be adopted by the entire nanotechnology industry and its regulatory authorities. This draft framework has been worked on for over two years and is designed pro actively to head off possibly restrictive pre-clearance regulation by the U.S Government sometime in the future. DuPont and Environmental Defense should be commended for a splendid and most comprehensive effort, but at the same time recognize that although many of the tests and evaluations included in the draft are obviously of universal necessity, the rest will tend to stratify the industry into those that can afford to follow the guidelines and those smaller companies that will find their progress in commercializing their inventions inhibited and sometimes prevented by imposing the requirements suggested in this draft (despite the word "flexibility" scattered throughout the draft). Potentially, this draft, if adopted, can be the nanotech version of Sarbanes-Oxley - the accounting law that is so burdensome for small companies.
The draft says: "Environmental Defense and DuPont worked to develop a comprehensive, practical and flexible system, or "framework," for evaluating and addressing the potential environmental, health, and safety risks of nanoscale materials. Further, the Framework is designed to be a tool for documenting and communicating the steps a user has taken - along with the basis for them - to address those risks. We believe that the adoption of the Framework can promote responsible development of nanotechnology products, facilitate public acceptance and support the formulation of a practical model for reasonable government policy on nanotechnology safety."
This is a serious effort to develop guidelines and structure for the industry. The draft defines six sequential processes (with feedback) and calls for the designation of a responsible (legally?) executive in each institution who is charged with following the framework. The six processes are: 1. Material Description and Application; 2. Profiling of Life Cycles - properties, hazards, and exposures; 3. Risk Evaluation; 4. Risk Management Assessment; 5.Decisions, Documentation and Actions; 6. Review and Adaptation. Then, in its appendix it offers the "killer" … a 15-page worksheet of detailed distinctions and procedures to follow. The worksheet is a burdensome load, if followed exactly … even for a large corporation. If required for a smaller to medium sized nanotech venture or company the procedure, as described, will be a death sentence for that corporation … a financial and labor intensive time consuming procedure that will serve solely to inhibit the commercialization of nanotechnology for the good of mankind and possibly drive that company to merge or dissolve. Without major modification, the draft framework is a non-starter for many of our best nanotech companies.
There is a mitigating possible alternative. Everyone agrees that it is better for the nanotech industry to impose it's own standards and criteria in congress with the environmental, safety and eco groups than to have the government impose pre-marketing regulations and standards that are restrictive and keep good nanoproducts and benefits off the market. Some compromises practically have to be made. The industry can't be choked to death by the fear and scare tactics employed by some of the ‘green" lobbying groups. Nor can it be cavalier and not accept that there may be elements of nanotech that are environmentally unfriendly and need restriction.
What hasn't been considered is how to keep the smaller nanotech companies in business while assuring the general public that the commercial products these small, highly innovative companies are creating and introducing to the market won't harm those who use them or do damage to other environmental elements (or life) on disposal and/or recycling.
Why doesn't the nanotechnology industry create a quasi-independent entity like the Underwriters Laboratory? A UL listing on an electrical device is a stamp of approval for the safe use of the product under most condition. If the industry created a Nanotech Laboratory that was fully funded by the industry, received a major annual grant from the Government, and was designed to have all relevant instrumentation and provide testing procedures agreed by interested parties to test and rate new nanotech product offerings, most in the world could feel comfortable that similar standards and tests are being applied to any product with a NL listing. A small nanotech company then would not then have to add to its staff many environmental and safety testing people or to incur huge expense by outsourcing all testing to meet the requirements of a framework like the DuPont framework just to introduce its developments commercially. It could simply send the product with preliminary analyses (along with a fee in dollars to be determined by the scope of testing required) to the Nanotech Lab for testing and listing. By centralizing and standardizing environmental and safety evaluation and rating in its own certifying laboratory, the industry could go a long way toward making the general public accepting of new nanotech developments coming from all those small innovative nanotech ventures.
An advantage of a centralized and authorized independent testing company is that testing results and knowledge would be cumulative in the laboratory, and soon the NL would be a repository of most wisdom regarding nanotech safety materials and effects. The industry could draw on this centralized growing body of knowledge in product development and could also benefit from speedier "listing" as those working at the NL recognize similar prior tests and analogies that could characterize "new" presented products and quickly approve them.
Nanotechnology has been strangled during the past year by the regulatory and safety phobias. It is time to create practical solutions, and get on with bringing the benefits of nanotech rapidly and safely to civilization.
Alan B. Shalleck
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