Rae Hintlian

Associate Editor

Loyola University Chicago School of Law, J.D. Candidate 2019

The Department of Health and Human Services, along with National Institute for Occupational Health and Safety and the Center for Disease Control have begun a concerted effort to fill the knowledge gaps in defining the hazards, exposures, and risks involved with handling nanomaterials. Investigators are working to provide guidance for those working in the field of nanotechnology to address the risks associated with working with animals exposed to various engineered nanomaterials, epidemiologic research, and exposure limits.  The National Institute for Occupational Safety and Health has summarized its progress and recommended risk management strategies for those in the field.

Background

Nanotechnology is the manipulation of matter on a near-atomic scale, producing new structures, materials and devices. This technology has many applications in the advancement of medicine, consumer products, energy, and materials.  Given the size of nanotechnology (between 1 and 100 nanometers), the material exhibits unique properties which affect its physical, chemical, and biological behavior.  The heart of the technology is the research, development, and utilization of each of these unique properties.  Workers within this industry are thus exposed to unique materials, engineered at novel sizes, shapes, and with new physical, chemical and biological properties.  There is minimal information available on the exposure risks, levels, and toxicity of many of the nanomaterials currently used and under development in research. In 2003, the National Institute for Occupational Safety and Health began a health and safety initiative for nanotechnology.

Nanotechnology and the commercialization of products and devices developed by nanomaterials have been used to address global problems concerning energy, transportation, pollution, and health. While the potential benefits of the technological uses is immense, the scientists behind this technology face many potentially adverse health effects.  Until recently the hazards, exposures, and risks have gone unquantified, placing those working in the field unprotected.  While the National Institute for Occupational Safety and Health (NIOSH) has taken the lead on developing a set of regulations and guidelines to protect researchers, there are still many unanswered questions.  Many nanomaterials use advanced synthesis techniques which may be used to create a limitless combination of physicochemical traits, each with its own unique toxicology and exposure risk.  Such that, nanomaterials currently under development and those which may be developed in the future present a unique problem to creating a comprehensive guidance on working with advanced nanomaterial which are continually growing in number with additional potentially hazardous characteristics which will need to be addressed in the future.

The Proposed Guidelines

Earlier this year NIOSH presented a research plan for the protection of the nanotechnology workforce. The NIOSH research plan for 2018-2025 updates the previous December 2013 plan by implementing knowledge gained from ongoing research on the safety and health implications of engineered nanomaterials.  The NIOSH Nanotechnology Research Center (NTRC) coordinated with the NIOSH nanotechnology research program to develop a comprehensive, institute-wide plan supporting multiple sectors of the National Occupational Research Agenda (NORA).  The plan creates a roadmap for advancing the understanding of nanotechnology toxicology and workplace exposures and implements risk management practices for the discovery, development, and commercialization of engineered nanomaterials during their lifecycle.

The research plan seeks to continue to collect the knowledge from current research by using the information gained from researchers who continue to explore and characterize potential hazards and risks associated with nanomaterials.  The goal is to develop a foundation for anticipatory and proactive approaches to introducing nanomaterials to advanced manufacturing.  The NTRC coordinates nanotechnology research across the institute, focusing on ten critical areas of research.  Toxicity and internal doses, measurement methods, exposure assessment, epidemiology and surveillance, risk assessment, engineering controls and personal protective equipment (PPE), fire and explosion safety, recommendations and guidance, global collaborations, and applications and informatics are just a few of the areas being look at to develop a compliance program.  Each topic has a minimum of one key scientist who serves as a coordinator. The coordinator is responsible for developing and guiding NIOSH scientific and organizational plans.

Nanotechnology must be developed responsibly in order to ensure it is able to continue to provide great benefits to society. This involves caring for the workers developing the technology.  The new strategic plan seeks to address the nanomaterial worker safety and health, responsibly develop technology, and continue to provide benefits to society. A continual challenge to the program is determining a method of conducting timely research which addresses the elements of hazard identification through risk management. The process for managing potential exposures to engineered nanomaterials (ENMs) and assessing the appropriate the risk management strategy for their synthesis, manufacture, and incorporation into new materials or devices has been devised into five steps: (1) identification and characterization of the health and safety hazard; (2) dose-response risk assessment; (3) extent of exposure assessment; (4) risk characterization based on exposure; and control and management procedure development. For processes which involve the refinement of nanomaterials for use in high-volume commercial manufacturing scientists are seeking to develop methods or recognizing characteristics for anticipatory and proactive guidelines. The high-volume, emerging ENM’s are prioritized for toxicology testing and field evaluations of work-place exposures.

Conclusion

The main focus of the plan is to generate data, information and knowledge to protect the workforce, while developing effective risk management procedures and minimizing elemental exposures. The research will catalog, share data and information using resources, devices, and methods required for optimizing acquisition, storage, retrieval, and use of information.  To fill the knowledge gaps the research plan focuses on specific research needs while prioritizing the needs of the National Nanotechnology Institute. This will build upon the initial data and information collected, further increasing the understanding of the initial hazard findings of engineered nanomaterials. The compiled findings will provide the baseline guidance for developing a regulatory and compliance standard for nanotechnology research.  NIOSH has continual plans to develop a comprehensive guide for working with these materials, with a projected revision to the current 2018-2025 plan set to be released in early 2025, building upon the knowledge gained under the current strategic plan.