Timing and standardssetting

With the rapidly emerging field of nanotechnology, it is important to balance the need for free inquiry with the need to protect society through the development of standards. Standards are needed for basic research laboratories, product development laboratories, and manufacturing facilities. Environmental standards and consumer health and safety standards are needed.

When should discussion and identification of standards for new technologies begin? This is a critical point of debate between scientists, governments, NGOs, industry, and the general public. Discussion centered on three interrelated themes: (1) beginning the standards-setting process for nanotechnologies early in the knowledge development process, or later as such knowledge is applied to the development of new products and processes; (2) developing a timeline that is acceptable to all interested parties; and (3) addressing these issues appropriately and strategically with respect to global economic competition. The following is a synthesis of ideas surrounding these themes. Standards will need to be developed for such aspects of the new nanotechnologies as research, production, products, and waste disposal. At the same time, it is likely that standards will vary by material and product.

Research

Research standards should initially entail the use of Good Laboratory Practice (e.g. special gloves, respirators, and hoods). Many gloves used today in conventional lab work are ineffective for preventing penetration by nanoparticles. Some companies and universities already employ standards for Good Laboratory Practice. However, fully eliminating exposure might have the effect of creating a de facto ban on nanomaterials. Since university-based research is often conducted further upstream from industrial research, it may require standards that are different from those for industrial research. At the same time, virtually all universities are faced with declining resources for facilities. We need to ensure that researchers, post-docs, and students are adequately protected from what remain largely undefined or poorly defined hazards. Given the scarcity of information about risks associated with nanotechnologies, initial information and insight should be collected based on experiences in the laboratory. This suggests that there is already a need for standards for reporting incidents of concern, for providing guidance on what kinds of incidents should be recorded as "potential negatives," for reporting certain incidents should be reported to pertinent agencies.

Production

Standards are needed to protect workers from exposure. The highest exposure risks are likely to occur during the production phase, not in the final products. There are means for reducing risk during the production phase. If risk is a function of exposure and hazard, and we do not know what the hazard is, then we should at least reduce the exposure. The National Institute for Occupational and Health has a good track record in working with industry in similar situations. Its expertise should be welcomed.

Products

Indeed, one problem posed by the new nanotechnologies is that every new product seems like a special case. Moreover, different products will fall under the jurisdiction of different regulatory agencies. For example, a product which is overtly therapeutic will fall under the FDA approval process and require clinical trials. Food and drug products will likely need standards as soon as products are developed. In contrast, there is less urgency for non-consumable products, although environmental issues still need to be addressed. Even the determination as to whether a new food or drug product is substantially different requires a standard. Furthermore, there are naturally occurring nanoparticles in our food and in other consumer goods now. We will need to differentiate between these naturally occurring nanoparticles and those that are manufactured. One issue of considerable importance with respect to products will be public disclosure. Many, if not most, nano-products will involve Confidential Business Information (CBI); therefore, only the commercial applicant's lawyers' summaries (of risk relevant data, for example) will be available to the public. Currently, no pre-market notifications are required for nano-products. According to the manufacturers, nano-tubes are in tennis rackets now. Labeling may pose yet another set of problems. The insurance industry is likely to have a significant effect on the use of nanotechnologies in consumer products. Currently, insurers are uncertain about their capacity to insure against damages resulting from the production or consumption of products with nanomaterials due to the lack of standards, and their inability to calculate their actuarial exposure to economic risk. One effect of this uncertainty will be pressure on firms using nanotechnologies to self-regulate in order to avoid tort cases.

Waste disposal

Once nanoparticles are brought together in a product such as a tennis racket, do they come out again? These particles pose a unique end-of-product-life concern. Virtually all industries have environmental discharges, and many engage in wastewater treatment. Currently, nanoparticles are not differentiated in industrial processes, so waste streams are not separated. Moreover, the liquids in which nanoparticles are stored may be demonstrably more toxic than the particles themselves. Furthermore, because filtering processes were intended to catch much larger particles, it is likely that current waste treatment procedures and processes are not sufficient to filter out nanoparticles. Given the differences in the behavior of chemicals at the nano level, it is conceivable that the Environmental Protection Agency (EPA) will need to re-review every chemical in its database. The task will be daunting, and one for which funds are currently lacking. This suggests that standards need to be developed now to prioritize according to toxicity and likelihood of use.

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