A​s another year comes to an end, it is time once again to reflect on an important component of the continuous improvement process: our annual review of the health, safety, and environment management system (HSEMS). At a rudimentary level, most HSEMSs can be described as sustainable and systematic approaches for identifying and managing risk. Before risks can be managed, however, they must be identified, profiled, and communicated to the organization’s leadership. Through articles published in the October 2014 and February 2015 issues of The Synergist, members of the AIHA Nanotechnology Working Group provided a synopsis of how emerging technologies such as nanotechnology ar​​​e creating a new class of advanced materials. These articles also discussed the economic promise of utilizing these materials and the potential risks associated with their introduction into the workplace. This article discusses nanomaterials from the end-users’ perspective. Users’ participation in the annual HSEMS review can help determine whether the introduction of advanced materials into the workplace is being managed responsibly. Although the concepts discussed in this article focus on end users, they also apply to any stage of the advanced materials lifecycle. The process most organizations use to evaluate the risk of introducing traditional materials typically includes review of safety data sheets (SDS) and toxicology literature, a reliance on professional judgment, and experience with similar materials. But this process may not be applicable to nanomaterials due to inadequacies in SDS content and a nascent understanding of which physicochemical characteristics may induce potential adverse effects. A primary concern associated with advanced materials is that existing risk assessment processes are inadequate. Historically, when new materials enter into commerce, not enough knowledge exists to ensure responsible management. Risk-averse organizations may delay adoption of advanced materials due to the difficulty of constructing risk profiles from incomplete information on exposures, health hazards, and emergency response. These difficulties are compounded by the interdependency of risk profiles developed to accommodate sequential stages in the lifecycle of advanced materials.
RESOURCES Chemical Health and Safety: “Occupational health categorization handling practice systems – roots, application and future” (July/August 2005). German Social Accident Insurance: “Nanoparticles at the Workplace: Criteria for Assessment of the Effectiveness of Protective Measures” (2009). Good NanoGuide. JOEH: “Nanoparticle emission assessment technique (NEAT) for the identification and measurement of potential inhalation exposure to engineered nanomaterials - Part A” (March 2010). Journal of Nanoparticle Research: “Development of risk-based nanomaterial groups for occupational exposure control” (September 2012). ISPE: ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment, second edition (May 2012). NIOSH: Nanotechnology Web page. OSHA: Nanotechnology Web page. The Synergist: “Industrial Hygiene Practices for Assessing Nanomaterial Exposures” (November 2013).
RISK IDENTIFICATION, PROFILING, AND COMMUNICATION Before introducing advanced materials into the workplace, it is essential to communicate potential risks, and the costs associated with responsibly managing those risks, to the organization’s leadership. Management must have the information necessary to conduct a cost-benefit analysis and determine whether potential or perceived risk exceeds the organization’s threshold for acceptance. If acceptable, management has the responsibility to allocate sufficient resources for managing the risk. The HSEMS review will likely include discussion of whether introducing nanomaterials triggers product review protocol. End-users might want to know whether a process exists for developing risk profiles and communicating this information to the appropriate decision makers. In addition, end-users might ask whether the risk profile is sufficient to answer the following questions:
  • What is the nature and magnitude of potential risks?
  • What is the likelihood of adverse effects occurring and the level of disruption?
  • What costs are associated with managing each type of risk?
  • How effective are the controls that will be implemented to manage these risks? Are the controls sustainable?
HSE MANAGEMENT SYSTEMS HSEMSs take many forms, but most can be traced back to the “Plan, Do, Check, Act” approach. Plan Two important planning actions are formulating a policy that states management expectations concerning the responsible integration of advanced materials and developing a strategic plan to implement management directives. In addition to a general HSE policy statement, organizational leadership should consider developing an HSE policy for advanced materials that states the company’s commitment to implementing best practices and ensuring that these expectations are disseminated throughout the work force. The policy should provide clear direction for introducing advanced materials and facilitating the allocation of resources necessary for responsible management. Strategic planning should be proactive and incorporate a precautionary approach throughout the advanced materials’ lifecycle. This is especially important given that knowledge gaps and health risks might become apparent only after a long period of use. Acknowledge this uncertainty in the planning documents by establishing minimum criteria for building infrastructure and other resources necessary to safely work with advanced materials. Policy and planning should align with the financial constraints of the organization. For instance, budgets should consider all costs associated with managing advanced materials, including facility infrastructure such as local exhaust systems and isolation areas. The temptation is to make do with existing equipment, which may not provide adequate protection.
  • During HSEMS review, end-users of advanced materials may want to ask the following questions:
  • Has management determined how advanced materials will be managed?
  • Has management adequately allocated resources to safely work with these materials?
  • Has this determination been issued as a written policy?
  • Are employees aware of the new policy on advanced materials?
  • Has a strategic plan for responsibly managing advanced materials been developed and implemented?
  • Does the strategic plan address fire and other emergencies?
  • Is an effective system in place for monitoring the performance of risk management activities associated with advanced material use?
  • Are employees aware of their roles and responsibilities?
Do Planning is critical to comprehensive risk management, but identifying activities and responsibilities necessary to minimize hazards is equally important. In particular, as the work begins to develop, resources are distributed and responsibilities are assigned. In most cases, we approach this step with the belief that we’ll have the flexibility to change if necessary. But in practice, change during implementation is often arduous. Because of the unique physicochemical characteristics of advanced materials, the industrial hygienist is tasked with acquiring a host of new resources. A unique approach to exposure and risk management may be required, particularly where historical methods for aerosol sampling have proven inadequate. Similarly, traditional systems for containment and control may no longer be appropriate. A precautionary approach could therefore require major changes. One means of limiting change is to conduct the initial assessment via a qualified multidisciplinary team. By consolidating resources, we can often avoid making unnecessary changes or—more importantly—overlooking conditions that could increase exposure risk. No single approach can ensure total effectiveness; a unique determination on how best to manage risks will be necessary for each new facility and advanced material. The team approach is one way to meet this goal. A few approaches provide flexibility and allow for de-escalation of controls where appropriate. The first and easiest method is to model the process using a non-hazardous surrogate. Through modeling, traditional industrial hygiene methods can be utilized to determine likely exposures with extreme accuracy (picogram/cubic meter). There are also a number of categorization systems capable of estimating the level of exposure that results in minimal risk. Incorporating such flexibility into the typical HSEMS review helps determine the appropriate level of exposure control and ultimately reduces costs. While surrogate testing and health hazard banding (categorization) aren’t new, their application to industrial processes is somewhat unique. In the world of advanced materials and undefined toxicology, these sophisticated tools may be the only options for adequately determining the appropriate level of controls. By assessing the Lowest Observable Effect Level (LOEL), regardless of impact, we can incorporate a bit of the precautionary approach and place most new materials into one of a few simple health bands. Next we can determine the applicable OEL, ranging from nuisance dust levels to those within our limits of detection. This approach may seem simplistic, but it has proven effective in determining controls for radioisotopes and biopharmaceuticals. Once we’ve defined a health banding level, we can use the OEL to determine the appropriate level of engineering control. If health banding reveals a biological effect level (LOEL) under 10 µg/kg or an OEL less than 50 ng/m3, stringent containment levels will be required. But measuring these low levels is challenging. We could use particle counters to compare release against background or attempt to measure the airborne contaminants themselves. Ideally, however, we would validate the containment system well in advance of introducing materials into it. One established means of validation in advance of real work is to apply practices developed by the International Society of Pharmaceutical Engineers. Selecting an appropriate surrogate poses its own unique challenge, but we can choose from a wide range of compounds, some of which have detection limits well into the low picogram range. By combining existing techniques for health banding and surrogate testing, we can select and validate the necessary engineering controls and avoid what could be an excessively precautionary approach.
About the AIHA Nanotechnology Working Group The Nanotechnology Working Group (NTWG) comprises volunteers and representatives from AIHA’s technical committees. The NTWG’s goal is to identify, organize, and conduct information sharing, educational activities, and community outreach in nanotechnology safety and health, and provide members with networking and collaboration opportunities. NTWG volunteers help shape policy, standards, and regulations. To learn more or get involved, visit the NTWG Web page.
Risk-averse organizations may delay adoption of advanced materials due to the difficulty of constructing risk profiles from incomplete information on exposures, health hazards, and emergency response.
Check This portion of the HSEMS defines the acceptable endpoints and how they will be measured. In other words, are the risks associated with advanced materials effectively managed? A good practice when introducing new HSEMS policies and processes for managing advanced materials is to include performance measurements such as: audits to ensure compliance of established processesreal-time particle measurements to ensure efficacy of process containment or other engineering controlsperiodic use of surrogates to measure efficacy of process containment periodic review of the toxicology literature to confirm appropriate control bands were selectedarea and wipe samples to compare to internal performance endpoints personal air samples to compare to NIOSH recommended exposure limits (RELs) for nanomaterials or other internally established OELsDefining acceptable performance poses a unique challenge due to the limitations in equipment and information, uncertainty in risk assessment processes, and lack of size-specific OELs. The resources listed below include a number of publications and websites that can help industrial hygienists define acceptable endpoints and methods for measurement. Monitoring risk management activities involves identifying the causes of inadequate performance and the changes needed to improve performance. But we shouldn’t overlook successes: understanding the activities that led to success will help us allocate resources to make them sustainable. Act Available safety information and processes can frequently change, so it’s crucial to revisit plans, policies, and risk assessments. When dealing with new technologies, it may be necessary to review such areas more than once a year, depending on the project. An HSEMS should promote flexibility since the system must adapt to new risk information, anticipation of new hazards, sampling, process changes, and so on. HSEMSs are based on iterative design methodologies and can be refined based on new information. Each review of the system is an opportunity to refine and improve, which is ideal considering the evolving nature of advanced materials. It’s important not to overlook feedback loops. Is there an effective process for informing key decision makers of monitoring results and proposed corrective actions? Unless management commits in advance, it may be difficult to obtain the resources necessary to act on monitoring results and improve HSE processes. EFFECTIVE MANAGEMENT An HSEMS provides a framework through which an organization can effectively and safely manage its use of advanced materials. While a high degree of uncertainty is associated with these materials, their risks can be effectively managed. A Plan-Do-Check-Act approach helps stakeholders within the organization better communicate, identify, and prioritize risks, define controls and measure their effectiveness, and ultimately reduce the risk of harm and liability. MICHELE SHEPARD, PhD, CIH, is NTWG chair and a senior consultant with Colden Corporation. She can be reached at (518) 490-2261 or shepard@colden.com. PAUL WEBB, CIH, CSP, is NTWG vice-chair and a senior consultant at Colden ​Corporation. He can be reached at (508) 733-2405 or webb@colden.com. JOHN BAKER, CIH, is NTWG secretary and a senior project manager at Bureau Veritas. He can be reached at (281) 832-2894 or john.baker@us.bureauveritas.com. AMANDA ARCHER, CIH, CSP, is NTWG secretary-elect and industrial hygiene, chemical and radiation senior manager at MedImmune. She can be reached at (240) 343-0257 or archeram@medimmune.com.
 
Acknowledgements: This article incorporates knowledge and insight from the AIHA Nanotechnology Working Group. Special thanks to the NTWG executive leadership, including Jennifer Dimitri, Donald Ewert, Bruce Stockmeier, Charles Geraci, Kevin J. Sheffield, Lawrence Gibbs, Mark Hoover, Tom Peters, Michael Rosenow, Rebecca Lally, and Candace Tsai. More information about NTWG is available online.
Responsible Management
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Nanotechnology ​and HSE Management Systems
BY MICHELE SHEPARD, PAUL WEBB, JOHN BAKER, AND AMANDA ARCHER