The world of Occupational Health and Safety (OSH) is changing rapidly.  The global socioeconomic environment for OSH is shifting as a result of increased trade.  The boundaries and limits of risk analysis are shifting as national and sectoral differences become more apparent and legal frameworks are modified.  Similarly, the tools and techniques of risk analysis are not themselves static but are in flux.  In addition, the technologies of governance are changing as much of the world moves from direct government regulation to certification and accreditation with government oversight.  Furthermore, the new nanotechnologies pose a number of critical issues for OSH in that they (1) are largely novel and as yet ill-defined, (2) demand the creation of new or modified measurements and measuring devices, and (3) are peculiarly reflexive in the sense that they may be used to enhance measurement of and testing for OSH, and perhaps to improve OSH even as they pose OSH issues.  Finally, these technologies raise important issues of control over testing:  As nanotechnologies shrink the size and reduce the cost and time involved in testing – as agencies can be put on a chip – who will control which tests will likely be highly contested.  An informed policy would be based in part on the expectation that the current tools, organization, and division of labor for OSH is likely to change, perhaps in some unpredictable ways.

Nanomaterials are opening up opportunities that seem as limitless as the nanometre is minuscule. Enthusiasm has spread beyond the small group of nano-experts to growing numbers in the business and scientific communities who claim that a real industrial revolution is under way, embracing one sector after another.

Some of this is hype; much is not – and great opportunity is always accompanied by risk. Insurers, as risk-carriers, must be able to recognize and understand emerging risks; only in that way will they be in a position to safeguard their clients over the long term against the financial consequences of adverse events, and so enable economy and society to take the risks that allow them to move forward.

There are two fears about the interrelation between nano-technology and occupational health and safety. The first is that some currently unforseen risk will surface and cost worker health and huge expenses to firms, per asbestos.  Imagine the impact of a headline "sperm count down because of reproductive toxicity of metal oxide nanoparticles. The second is that unfounded fear of the technology will reduce its spread and investments of firms.  Five decision-making groups will determine social response to these fears:  firms, and insurers; workers and union organizations representing them; regulators and administrators; consumers; and scientists and engineers. Economic analysis applies benefit-cost calculations to these issues. In addition to the basic knowledge/estimates of benefits and costs of health, the analysis highlights the potential that nano-particles can affect social behavior, per the contribution of lead to crime.  It  depends critically on the discount rate applied to benefits and costs (per debates over the economics of global warming) and of risk aversion that depends on the whole distribution. The big problem is that most distributions of risk have fat tails. I propose that analyses focus on worst case scenarios and that betting markets be used to combine the disparate information of various experts for risk assesment.  

Nanotechnology currently occupies a position with more than a little resemblance to a status that nuclear technologies once enjoyed.  This may seem surprising, given that nuclear power may offer the 20th Century’s clearest illustration of the loss of scientific credibility, but for decades after the splitting of the atom, nuclear technologies enjoyed widespread and even enthusiastic support, being endorsed  not just by the scientific elite, but also by many of the leading environmental activists of the day, including the Sierra Club.  Nuclear technology was also supported by a “public education” budget that present-day proponents of nanotechnology can only envy —- all duing the pre-Watergate years when the government enjoyed considerably more credibility than it does today.

The high levels of public support continued for roughly forty years.  The support, however, quickly became a matter of history after less favorable kinds of “education” were produced by what Slovic has called “signal” events —- those sending “signals” that nuclear technologies were not being managed with the degree of vigilance that the public saw as being necessary.

As the nuclear experience illustrates, trust is easy to lose, but difficult to build —- even for a field of technology that initially appears to have a nearly boundless future.  Given that a small number of unfortunate incidents can create a major problem of credibility, it stands to reason that the persons with the strongest incentives for preventing even “minor” lapses in the protection of human health and the environment would be precisely those who care the most about the long-term future of nanotechnology.

Science, government, and industry are all concerned about the possibilities for social amplification of nanotech risk perception among the US public. Congressional aims for nano societal implications research “to avoid public misunderstanding” and mandated public participation in nanotech R&D reflect such concerns, and the CNS-UCSB is engaged in the study of nanotechnologies’ potential for such amplification.

However, lessons from other worker risk perception research point to a far less frequently discussed problem in hazards research—that of the attenuation of risk. California farmworkers exposed to agricultural chemicals in the workplace display forms of attenuated risk perception (optimistic bias) about their exposures and likelihood of sustaining harm. California’s pesticide regulation system is widely regarded as the best in the country, yet worker exposures are frequent and many go undocumented. Consistent with the privatization of risk in many other spheres of society, strong emphasis has been placed on worker self protection as the preferred method to reduce workplace exposures. However, workers displaying optimistic bias about risks are not going to take self protective measures. Similarly, attenuation of perceived risk is a widespread finding among many kinds of experts. If neither experts nor workers in the nanotech context are likely to engage in adequate self and other protection from workplace exposure risks, then such protection should be a matter for policy makers.

The external environment constitutes an important destination for engineered nanomaterials with many and diverse implications for human society.  Benefits of nanomaterials and nanotechnology broadly to the environment are in environmental quality and pollution monitoring, pollution cleanup or remediation, clean energy production, energy conservation, and efficient water purification.  Such beneficial applications involve deployment of nanomaterials into air, water or soil either as nano-sized particulates or embedded within matrices.  As with any manufactured material either deployed or released into the environment, additional considerations regard the spatial extent of either controlled or uncontrolled transmission, physical or chemical modifications, longevity, effects on organisms by either native or modified forms, and society’s ability to manage outcomes when needed.  In this presentation, environmental benefits and concerns of engineered nanomaterials are reviewed.  Primary data in support of relevant potential biological interactions in the environment are used to exemplify specific nanomaterials fates.  Additional environmental considerations, beyond those commonly delineated in the nano-safety and risk literature, are discussed.  Needs for new information are suggested against the backdrop of how society already manages analogous concerns with existing, particulate and non-particulate, industrial materials.

As nanotechnology moves from development to commercialization, there has been growing interest in understanding production costs and occupational health risks associated with various nano-manufacturing processes.  Recent papers (EPA 2007; Maynard 2006) indicate that engineered nanomaterials may present potential risks to human health. Nanomaterials that are most likely to present health risks include nanoparticles, agglomerates of nanoparticles, and particles of nanostructured material.

Commercialization of nanotechnology continues to progress, however, with limited guidelines on safe work practices (NIOSH 2006). Because it may take several years to generate information and consensus, Monte Carlo (MC) simulation risk models may help explore the potential consequences of and tradeoffs between manufacturing costs and health risks, given the uncertainty about occupational exposure and EHS regulations. 

Using classical risk analysis and Bayesian uncertainty approaches, we have developed a preliminary Monte Carlo simulation model to explore the potential range of production costs and health effects associated with various levels of occupational safety requirements (engineered controls, personal protective equipment, etc.). Production costs for alternate manufacturing processes (HiPco, arc ablation, chemical vapor deposition) of single wall carbon nanotubes (SWNTs) were calculated for four alternatives in industrial hygiene practice. Uncertainties in the extent and the timing of possible requirements and the occupational health dose-exposure relationship are represented by probability distributions and chance events. Since the risks for commercializing SWNTs are likely to remain unclear for the foreseeable future, these models allow analysis of various scenarios and economic-safety-health tradeoffs.  Preliminary results suggest that in some cases, voluntary adoption of standards higher than initially required can lead to the lowest expected cost with the least uncertainty.

The public response to risks introduced by emerging technologies is historically shaped by the novelty of that risk, the perceived benefits associated with that research or manufacturing, and the extent to which that sector is seen as a good-faith participant in efforts to establish reasonable public accountability and assurance in three areas: occupational and public health risk, environmental risk, and consumer risk.  The agencies responsible for product and drug safety (federal) or for environmental compliance and management (mostly state and federal) are struggling to address the challenging uncertainties posed by nanomaterials and the products or therapies that utilize these materials.  It is widely accepted that there must be a framework for understanding and managing risk and uncertainty from these processes , materials and products that is capable of  working around the extensive absence of data for evaluating these risks.  Strategic plans for filling in the most critic gaps in toxicological information and occupational exposure dynamics are being plotted as we meet.  This is not an easy task and there is a great risk posed by the hydra-headed nature of this enterprise.
 
Protection of workers and residents from local hazards, unlike consumer protection or environmental enforcement, has been commonly recognized as a responsibility that is shared between state, federal and local officials with public health responsibilities.  These agencies include OSHA, NIOSH, EPA, and many state-level enforcement offices.  When there is an enterprise that is perceived to have insufficient or absent oversight at the state or federal level some communities have a history of local regulation of these hazards or practices.  The decision to take on a vanguard policy to address perceived public risk in an emerging technology sector is familiar to the city of Cambridge, Massachusetts.
 
In 1977, after a tumultuous debate that resulted in a moratorium on recombinant DNA experimentation or gene-splicing, Cambridge established the first local biological safety regulation in the world.  The form of this oversight has evolved from a setting in which this work was rarified and found only in a select number of academic laboratories to the present time, with a large biopharmaceutical sector  in the community (over 60 firms or institutions holding permits).
 
As we are now evaluating local oversight options to address uncertainties around nanomaterials exposures I look back on the lessons learned from the evolution and enforcement of the Cambridge Recombinant DNA Technology Ordinance.  I will discuss the mistakes and great successes that accrued to Cambridge by enacting local rules to  address risk from the emerging biotech sector and consider the parallels and incongruities with the nanotechnology sector. 

This presentation will explore cases from the twentieth century where new technologies or substances have been adopted and how public health and industry representatives have struggled over the potential harms and benefits of such changes. It will explore the historical antecedents of the modern arguments over the precautionary principle and specifically, the tension between public health principles and the interests of corporations who have extolled the benefits of new technologies and argued that their economic interested should not be undermined until science has proven that their new product or technology is dangerous.  

This presentation will discuss two collaborative efforts, including i) the development of a versatile and flexible Nanorisk Framework for evaluating and addressing the potential risks of nanoscale materials and ii) the findings from a multi-stakeholder consortium that focuses research on occupational safety and health associated with aerosol nanoparticles and workplace exposure protocols. 

Environmental Defense, an environmental advocacy organization, and DuPont, a science-based products and services company, have developed a comprehensive, practical, and flexible framework for evaluating and addressing the potential risks of nanoscale materials. The intent of this framework is to define a systematic and disciplined process for identifying, managing, and reducing any environmental, health, and safety risks of engineered nanomaterials across all stages of a product’s lifecycle. Our framework offers guidance on the key questions an organization should consider in developing applications of such materials, and on the key information needed to make sound risk-evaluation and risk-management decisions. The framework allows users to move ahead despite areas of incomplete or uncertain information, by using reasonable assumptions and by compensating for knowledge gaps with appropriate risk-management practices. Further, the framework describes a system to guide information generation and update assumptions, decisions, and practices with new information as it becomes available.  The framework also offers guidance on how to communicate information and decisions to key stakeholders.  The framework is intended to be relevant to a broad range of materials and applications, so that it can be accepted, endorsed, and adopted or adapted for use internationally by a wide range of stakeholders, including other companies, other public interest groups, academia and government agencies.

The Nanoparticle Occupational Safety and Health (NOSH) Consortium of international industrial, government and non-governmental organizations has focused research during the last two years upon generating science-derived knowledge on occupational safety and health questions associated with aerosol nanoparticles and workplace exposure monitoring and protocols. The technical goals of the NOSH Consortium include 1) generating well-characterized aerosols of solid nanoparticles and measuring aerosol behavior as a function of time; 2) developing an air sampling method that can be used to conduct worker exposure assessments in workplace settings; and 3) measuring barrier efficiency of filter media to specific engineered aerosol nanoparticles.  With the completion of the main phase deliverables, several technical advances have contributed significant understanding of the synthesis and behavior or aerosol nanoparticles, the monitoring of aerosol nanoparticles in the workplace, and the performance of specific filter media upon exposure to aerosol nanoparticles.

While the spotlight on nanotech’s impact on the end user and the environment continues to wax and wane, the discussion around its impact on the workforce is just starting in earnest. Despite growing interest, however, limited progress has been made. Uncoordinated research hasn’t clarified the picture on real risks significantly, while interest groups are driving perceptual risks in contrary directions. Regulatory agencies are reaching out to the nanotechnology community for data, but the process of formulation regulations will take years to draw to a conclusion. In the interim, nanotechnology firms should escalate efforts to understand real risks of the nanomaterials they produce and use – and aim to be free with their findings to both the public and regulators. The resulting data can contribute to shaping a balanced regulatory environment, and enable a more informed public dialogue which balances benefits of nanotechnology with the risks.

The talk will establish a framework whereby nanotech EHS and OSH issues can be studied, review the global nanotechnology-related safety and health initiatives surrounding different nanomaterial classes, delve into the key outstanding issues and propose a path forward.