Integration of operational standards

Nanotechnologies pose new challenges for operational standards. They must ensure that the health and safety of workers and consumers are protected and that environmental protections are developed and enforced as needed. In the past, these issues were the subject of separate regulations and regulatory agencies (e.g. in the US, OSHA, EPA, FDA, and USDA), with each holding responsibility for different aspects of the regulation of agriculture and food products. Integration of diverse standards regarding nanotechnologies is likely to pose new challenges for governmental regulation and nongovernmental standards. Discussion centered on three interrelated themes, including whether: (1) both private and governmental standards-setting agencies that have not historically worked in cooperation will begin to do so, (2) procedures can/should be established to ensure adequate integration among different standards agencies, and (3) unique challenges will be raised by this issue, and if so, how to identify the best strategies for addressing them.

Integration among agencies

In some circles there is an assumption that agencies will just start to work together as the need arises, but this is not likely to happen on its own. Instead, mechanisms must be established for interagency cooperation where it has not occurred before. Success in this endeavor is key, so we need to look for examples where different agencies have worked together cooperatively on standards and regulation in the past. Currently, in the US there is very little or no interagency talk on emerging nanotechnology standards and regulatory needs. For example, the EPA recognizes that there will be nano-waste to regulate, but they do not know much more than that. They do not know what the waste will be or how much of it there will be. There needs to be integration with other agencies that can help them understand this, and the integration needs to go beyond other regulatory agencies. Another good example is nanosensors and RFID tags, where there may be a need for the USDA to integrate their standards with those of the Federal Communications Commission. This probably has never happened before. Still, other agencies probably are not thinking about nanotechnology at all. For example, we doubt that Grain Inspection, Packers, and Stockyards Administration have considered the importance of nanotechnology regulation. Likely, they will need to do so. Therefore, mechanisms will need to be established to help them begin to see their role in this regulation. Compounding this, is a history of non-communication among regulatory offices. We need to foster better communication methods to overcome this history. A good place to start might be with integrated computer systems. A big challenge is information sharing, so the easier and more efficient information sharing between the agencies can be made, the better. Designing a central database appears to be a useful first step. There is, however, some tension between agencies when it comes to information sharing (e.g. who gets the credit?, etc.). There needs to be a focus on overcoming this. Oftentimes, barriers occur at a specific point. If communication can be facilitated at those points, the entire interagency process can be enhanced. Furthermore, each individual agency may have insufficient funds to accomplish this on its own. Additional funding will be extremely important to success. Ultimately, two things are needed: someone with the authority to integrate and an agency to catalyze the process. In the US, some entity other than the NNI should play this role, although its NNCO does have a similar function within the NNI. However, creating a completely new agency could conceivably generate more confusion. The bigger question remains which agency would take the lead and act under what mandate?

In this discussion, there was a conflict between top-down and bottom-up approaches to integration. However, it is difficult to provide an example of a top-down approach that has worked well. The Department of Homeland Security has a top-down model with enormous power and vast resources, yet its success is questionable. Therefore, bottom-up models of integration are needed. Moreover, the Coordinated Framework for Biotechnology (OSTP, 1986) should be examined to determine if a similar approach would work with a larger number of agencies.

Integration with private sector

Five of the top 10 food companies are major nanotechnology investors. These and other private/corporate investors have a great deal of information that is likely to be useful to the standards-setting process. Integration among agencies and also among all supply chain actors is also important. Wal-Mart is now a de facto standards-setting body for quality standards. Standards and regulations have historically ignored the complexity of the supply chain. Yet, integration with private sector players could help establish new approaches similar to hazard analysis and critical control points, commonly used in the food industry, along the supply chain. Instead of waiting until a product is complete, one can test it along the way. At the same time, we should be wary of the role that people/companies with a financial stake in nanotechnology play. Various US government agencies are collaborating with ANSI and ISO in standards development. ASTM's E-56 committee is also involved in nanotechnology standards development, and has recently released its standard "E-2456, Terminology for Nanotechnology" (ASTM Committee E-56, 2006). There is considerable overlap in membership among these and other standards organizations, and they may serve as a fruitful place to begin the discussion of standards integration. Finally, global integration will require cooperation among competing institutions. Typically, the tension that results from competition limits cooperation on regulation. Additionally, who integrates with whom becomes a point of contention.

Challenges: old and new

The greatest challenges are not so much unique, as they are persistent and unsolved. Such is often the case with new technologies. If we can solve the problems presented here, we will have taken a large step towards solving the regulatory challenges associated with all emerging technologies. These challenges lie largely in the complex social dimensions of technology. The proposed national animal identification system is a good example. Regulatory agencies thought this would be a simple matter of organizing a database and implanting tracking devices. However, it quickly became a larger social issue involving government knowledge of herd size, location, transport, etc. Also, with such a database a disease outbreak beyond a farmer's control can be traced back to the farmer. This poses potential issues of liability and social stigma. Yet another challenge to nanotechnology is that there are already products on the market that need to be reviewed for safety and efficacy by regulators, but it is not obvious who should do this. With nanotechnologies it will be important to set standards in parallel with product development so as to avoid this in the future. Also, nano-waste that has not been evaluated for health, safety and environmental risks already exists. Companies are unlikely to use their R&D funds for this type of research; a governmental body needs to do it, and sooner rather than later. In addition, the hazards associated with nanotechnology are largely unknown. This makes it difficult to assess how to proceed. Standards are needed for working in situations of uncertainty. Some form of the precautionary principle might be appropriate, at least until the hazards are more well-defined. Another challenge is the difference in money available to fund product R&D and money available to fund worker, consumer, and environmental risk research. A final challenge is commercialization of university research projects (spin-offs, private research parks, etc.). Nanotechnology research projects often involve an intensification of this trend. Historically, university research has been regulated differently than commercial research. However, as the boundary between universities and commercial firms blurs, the regulation of university research needs to be rethought.

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