Nanotechnology in the Workplace

US-EU CONFERENCE

8th US/EU Joint Conference on Occupational Safety and Health
Ft. Worth, TX
September 16-19, 2015

INTRODUCTION

Nanotechnology has demonstrated that it has the potential for great societal benefits. The introduction and use of engineered, manufactured nanomaterials (MNM) has already been seen in many business sectors, and a growing number of proposed applications are being developed. These applications range from light-weighting of structural materials in transportation and construction; cleaner and more efficient energy generation and storage systems; advanced sensing technology; targeted drug delivery systems; highly efficient and lighter thermal insulation; more protective and intelligent surface coating materials; and more effective methods for environmental remediation. Achieving these great benefits for society must be accomplished by safe and responsible development of this technology. Protecting workers involved in the discovery, development, manufacture, and use of MNMs is a mandatory element of responsible development and serves as a foundation for successfully addressing the overall Environmental, Health, and Safety (EHS) challenges of nanotechnology.

Some recent in vivo studies suggest that certain engineered nanomaterials and products may potentially cause adverse health effects. Recently, the International Agency for Research on Cancer (IARC) (Straiff et al., 2014) classified one specific carbon nanotube as category 2B (i.e. possibly carcinogenic to humans). This was one member of a broad class of materials that will continue to be evaluated. NIOSH has recently proposed two RELs for engineered nanomaterials: carbon nanotubes/carbon nanofibers and nano-sized titanium dioxide (NIOSH, 2013), and Dutch authorities have promoted the use of Nano-Reference Values (van Broekhuizen et al., 2012).

While a plethora of reports have indicated that engineered nanomaterials (MNM) may have wide use in consumer applications, workers remain the population most vulnerable to any potential adverse effects since this group has the opportunity for the first and potentially the highest exposures to the pure, free, unbound nonmaterial. Many national and international efforts have concentrated on worker safety issues; including academic and government research efforts and consensus committees developing guidance. At the 7^thUS/EU Joint Conference on Occupational Safety and Health, held in Brussels in 2012, representatives of labor, government, and industry developed 10 overarching principles to guide responsible development of nanotechnology. Work is still needed to more formally and deliberately identify a subset of those high-level principles for addressing occupational safety and health considerations for nanotechnology and MNM that are good candidates for further collaboration between the US and the EU. Acting on an achievable set of high-level principles would facilitate development of consistent global best practices for protecting workers without hindering international development of nanotechnology for societal benefits.

SCOPE

As work in addressing nanotechnology issues in the workplace has progressed sufficiently that it would be a timely and remarkable opportunity to establish a set of high-level common principles. These principles would be based on the current best available science, which can be applied across the globe for developing best practices and guidance for the safe use and handling of MNM in all occupational settings. Furthermore, these principles would build on the large number of research outputs and other efforts that have been presented and discussed at the numerous workshops and conferences recently held to address various elements of risk management for MNM. There is an opportunity to leverage the best available science from academia, government, and the private sector. The past and current efforts include, but are not limited to: 1) international efforts for assessing environmental and occupational release and exposure to ENM using a life-cycle approach; 2) international efforts to design hazard classifications and associated risk management measures; 3) workshops and reports focused on approaches to establish criteria for developing OELs for MNM; and 3) international research efforts on the expanded area of EHS of nanomaterials and the direct links to the workplace.

In fact, as research projects dealing with these issues are ongoing in both the US and EU, opportunities to build on existing and emerging knowledge are improving all the time. For example, organizations in the US and EU are working on measures which could be utilized in health surveys of workers who have been exposed to MNM at the workplace. Other areas of on-going research and candidates for closer collaboration include: harmonization of strategies and methods used to measure worker exposures; methods to measure releases from nanomaterial containing products; and effectiveness of engineering control systems.

Given the complexity of the topic and the rapid pace of change in the development and application of nanotechnology, the US feels it would be most productive to focus on a key number of topics out of the set presented below. The goal is to continue to advance the principles outlined in the 7^th Joint Conference by focusing on: establishing principles for measurements and monitoring; establishing principles for control; and establishing foundational principles for risk management practices would serve to continue productive collaboration opportunities on the key overarching principles developed at the earlier conference.

SUBTOPICS AND KEY QUESTIONS

The opportunity here is to identify material and process characteristics that would lead one to an evaluation, or re-evaluation of control and risk management practices in place.

'Gaps' in the legislative EU and US framework
Knowledge and information gaps continue to exist regarding potential hazards and risks associated with engineered nanomaterials. Within this category are the challenges of classification and labeling. From the EU perspective, there is currently activity under REACH, and there are National initiatives relating to traceability, risk communication, and Safety Data Sheets. From the perspective of current activities within REACH and GHS, the following discussion points should be considered:
A discussion point is to evaluate how Hazard information can be communicated in the US and EU using the GHS process for Safety Data Sheets and following guidance issued by ISO.

While there may be no legally enforceable exposure limits (PEL in the US), recommended limits (RELs from NIOSH) can serve as a starting point for developing guidance and ultimately adoption into a legislative framework.
- Which knowledge and information gaps are considered to be significant and how can these shortcomings be solved?
- What is the actual state of the art at this moment concerning these gaps on the national level, as well as on the US/EU-level?
  1. At present, there are no OELs to be implemented at the workplace level anywhere at a national level in the EU. However, several previous, as well as ongoing EU projects have developed draft proposals for OEL values to be considered for different industry sectors (e.g., the SCAFFOLD project for the construction sector), and also means for health surveys of workers in the same sector.
  2. In the US, NIOSH has issued two OELs for nanomaterials, TiO2 and Carbon Nanotubes and Nanofibers; and is leading the OECD project to develop guidance for deriving OELs for nanomaterials.
Establish criteria for identifying work-place hazards/risks
It is recognized that knowledge gaps still exist regarding the toxicological hazard associated with manufactured engineered nanomaterials (MNM). Knowledge of the mechanisms of these particle related hazards (CMRS, oxidative stress, overload) in relation to growing concern over exposure to process-generated nanoparticles (PGNP) is an area to be explored as noted. Interference and challenges with environmental background concentrations add to the complexity of this issue. Development of OELs, RELs and/or generic Provisional Nano-Reference Limit Values for MNM will assist greatly in addressing this area of investigation.
- Given the fact that there are knowledge gaps (unknown properties of MNMs, incomplete information about their hazards, etc.), what approaches are at hand to guarantee a safe workplace?
  1. At present, in the absence of nano-specific bioindicators, the most effective means to prevent MNM-induced health hazards may be at the maintenance levels of exposure below levels where health harm can take place.
  2. Promoting the continued development of hazard categories for MNM will accelerate establishment of criteria for hazard and risk determinations.
  3. Research on MNM will benefit greatly from the history of work already being done on ambient ultrafine particles and what is already known or being developed for PGNP.
Establish principles for measurements and monitoring
An area of productive collaboration continues to be research to develop methods and instruments for the measurement and characterization of engineered nanomaterials. This would include the development of equipment and methodologies, identifying limitations of methods and instruments, and developing and using standardized approaches and materials. The influence of agglomeration and aggregation phenomena should be investigated as a part of this area of research.
- What principles can be defined for measurement of MNM and monitoring of workers? What are the minimal requirements for exposure and risk assessment? Is a full health based assessment needed?
  1. At present, there are no nano-specific health indicators available, but currently used ones may be applied, as concluded by the SCAFFOLD project for construction workers.
  2. Strategies used by NIOSH and those published by ISO should be evaluated and compared with others, such as SCAFFOLD.
Establish principles for control
Engineering control and risk management strategies focused on mitigating worker exposure should continue to be evaluated. While control and risk assessment and evaluation strategies are being evaluated, areas to consider developing include, workers registration, periodic health surveillance, and identification of health-based early warning systems.
- Collaborative efforts should continue to address the question of traditional control measures being sufficient for nanomaterials as manufactured and/or used in the workplace.
  1. As suggested by some ongoing and recently completed research projects, "traditional" control measures can be helpful, but in some specific instances additional or modified control measures may be highly desirable
Establish foundation for risk management practices
Establishing a foundation for risk management practices is considered critical for the safe and responsible development of nanotechnology. This element should identify where there have been successes in managing new or emerging technologies. As discussed in previous conferences on the topic of nanomaterials in the workplace, in the situation where exposure limits are not available for specific nanomaterials, a precautionary approach should be applied. Principles and practices to explore and apply include the Precautionary principle, ALARA, Control banding, and Nano Reference Values.
- What precautionary and prevention practices concerning the use of nanomaterials can be developed? (linked with #2)
  1. Where major knowledge gaps on the association of levels of exposure to MNM and the occurrence of subsequent health effects exist, the most effective means to date might be controlling of exposure, or in some cases, limiting the production of certain MNM.
  2. An area of opportunity is to develop a base of experience with the various control banding tools that have been published and are in use.
Establishing principles for developing positive S&H work cultures where workers are included in decision-making process
Workers have the right to participate in the development of risk management practices involving nanomaterials in the workplace. Activities that have been identified include: worker training, health and safety knowledge and capacity building, identifying and developing approaches to ethical issues, increasing workers participation, including this topic in works' council affairs, and developing knowledgeable safety representatives.
- What is needed to increase awareness among employers and workers as to the potential hazards and risks and the need to work safely in this field?
  1. One approach to be considered as a part of sustainable nanotechnology would be the continued promotion of the safe-by-design principle in the designing of novel MNM. More emphasis needs to be placed on the growing research on design of safer nanomaterials.
- How to realize a mutual consensus on precautionary control policy amongst the social partners and governmental institutions.
  1. One potential approach would be promoting the engagement of key stakeholders in transparent nano-dialogue to enable a mutual understanding of approaches among stakeholders.

POTENTIAL OUTCOME

Develop a white paper that clearly establishes how future guidance and best practices for nanotechnology. This paper would clearly articulate the key areas of concern and develop basic high-level principles needed to identify and evaluate practices and strategies used to achieve safe and responsible development of nanotechnology. The ultimate goal being a process that establishes agreed upon occupational best practices for nanotechnology in any workplace setting utilizing the best available science and state-of-the-art approaches.