In light of National Nanotechnology Day on October 9, the American National Standards Institute (ANSI), spoke with two experts who have first-hand knowledge of nanotechnology-specific standards that are making a difference, from supporting terminology and measurement, to assessing toxicity and risk, to the safe handling of nanomaterials in the workplace. As nanotechnology transitions from emerging to mainstream technology, standardization work is crucial to support numerous sectors, including aerospace, homeland security, healthcare, textiles, and electronics —to name just a few.
ANSI recently heard from Vladimir Murashov, Ph.D., of the U.S. National Institute for Occupational Safety and Health (NIOSH) and chair of International Organization for Standardization (ISO) Technical Committee (TC) 229, Nanotechnologies, who gave his perspective on future areas and needs that nanotechnology standards can address. Joanne Shatkin Ph.D., president, Vireo Advisors and author of Nanotechnology Health and Environmental Risks, Second Edition, shared insights on how standardization is helping to advance industry, and identified key opportunities for future collaboration.
Interviews have been edited for clarity and length.*
ANSI: How have nanotechnology-specific standards impacted or benefited the advancement and commercialization and acceptance of nanotechnology applications and materials?
Dr. Murashov: ISO Technical Committee 229, Nanotechnologies, was one of the first horizontal ISO committees aiming to develop standards for emerging technology proactively rather than reactively. As such, it focused on—and has been quite effective at —setting broadly applicable and foundational standards on terminology, metrology, safety and health, material and performance specifications. The committee established a series of foundational definitions including “nanoscale” and “nanomaterial,” which are widely adopted and used globally.
Standard measurement techniques for specific nanomaterials play critical role in scaling up manufacturing processes to produce materials with consistent and well characterized properties. Early attention to the safety of new materials and globally accepted voluntary standards for their safe handling were instrumental in avoiding adverse health effects among workers and the general population, in addition to easing public concerns about products containing nanomaterials. These successes of global efforts in developing voluntary standards for nanotechnology assisted in transitioning nanotechnology from emerging to mainstream technology, which we are observing today.
Dr. Shatkin: Certainly, the terminology and measurement standards have greatly benefited commercialization by allowing specifications for materials and their properties, e.g., the ability to characterize and quantify nanomaterials and nano-enabled technologies forms the basis for R&D and commercial product development to allow consistent manufacturing and product performance.
2、ANSI: Can you identify standards which have made a significant impact on your area of expertise?
Dr. Murashov: In the safety and health area, in my view, two of the most impactful standards are ISO/TR 12885 – Nanotechnologies – Health and safety practices in occupational settings, and ISO/TR 13014 - Nanotechnologies - Guidance on physicochemical characterization of engineered nanoscale materials for toxicologic assessment.
The first document was also the first to be published by ISO TC 229 Working Group 3, which addresses environmental, safety, and health implications of nanomaterials. It was also the first to provide globally accepted voluntary guidance for safe handling of nanomaterials in the workplace. It was based on U.S. National Institute for Occupational Safety and Health guidance and has become a foundation for the development of national safety and health guidance in a number of other countries such as Korea, Thailand, and Canada. This document remains one of the most requested nanotechnology-related documents on the ISO platform.
ISO/TR 13014 addresses an urgent need to ensure that experimental toxicity data could be used in risk assessments of nanomaterials. Since toxicity of nanomaterials depends on their physicochemical properties unlike traditional chemicals, only experiments with properly characterized nanomaterials could provide scientific basis for making decisions about hazard and exposure to nanomaterials. This document provides a globally accepted list of nanomaterial parameters that should be measured prior to toxicological screening. It was instrumental in raising the quality of toxicity data generated in research laboratories around the world and in improving public confidence in risk assessment decisions for nanomaterials.
Dr. Shatkin: In the area of safety and environmental, health and safety (EHS), where I work, standards have greatly improved the ability to assess toxicity and risk of nanomaterials and nano-enabled technologies. A significant portion of the earlier studies on nanotoxicity were not reliable or repeatable because they were performed differently, with unspecified sample preparation methods, [with] no or poor physical and chemical property characterization, evaluated with non-standardized testing methods and with limited reporting.
The development of standards for sample preparation, physical, and chemical property measurement and reporting, test methods and risk characterization by standards organizations and others has meant significant improvements in the reliability of the outcomes of studies that built a solid foundational knowledge and has led to the development of frameworks for risk assessment, risk management, and regulatory decision making.
A few examples include the updated OECD Test Guidelines for nanomaterials; an OECD Physical Chemical Decision Framework for regulators; the recently finalized exposure assessment ISO standard, ISO/TR 22293:2021 - Evaluation of methods for assessing the release of nanomaterials from commercial, nanomaterial-containing polymer composites; and the many occupational exposure and risk management standards that have allowed research and commercial organizations to create safe work environments while manufacturing nanomaterials and nano-enabled products. Our work on carbon-based nanomaterials has benefited from several ISO technical standards and technical reports, i.e.:
ISO/29701:2010, Nanotechnologies - Endotoxin Test On Nanomaterial Samples For In Vitro Systems - Limulus Amebocyte Lysate (LAL) Test;
ISO/TR 13329:2012, Nanomaterials - Preparation Of Material Safety Data Sheet (MSDS);
ISO/TR 19716:2016, Nanotechnologies - Characterization Of Cellulose Nanocrystals;
ISO/TS 20477:2017, Nanotechnologies - Standard Terms And Their Definition For Cellulose Nanomaterial;
ISO/TS 22082:2020, Nanotechnologies - Assessment Of Nanomaterial Toxicity Using Dechorionated Zebrafish Embryo; and
ISO/TS 21346:2021, Nanotechnologies - Characterization Of Individualized Cellulose Nanofibril Samples, in addition to the related methods such as the NIOSH method for measuring carbon nanotubes in occupational environments (NIOSH method 5040).
For specific EHS questions where there are no standard methods, we have worked with the research community to develop test methods, and these can be less accepted because they are not standard approaches.
ANSI: What are some of the leading opportunities for nanotech developments to support consumer products right now?
Dr. Shatkin: There are many potential priorities for nanotechnology in consumer products, from lower energy electronic devices and wearables, to safer and more sustainable materials for personal care, cleaning, packaging, transportation, and buildings, as well as energy generation and storage. While these might not all seem like consumer products, people interact with these technologies every day.
Here are a few examples: Smartphones now connect to nano-enabled health and environmental monitoring devices to report on real-time wearer status. It’s not uncommon to find nano ingredients in hair care and skin products, for example, where liposomes deliver high performance ingredients. Self-cleaning coatings reduce water and cleaning chemical usage. Nanomaterials such as cellulose are improving oxygen barrier properties that can lightweight recyclable packaging, extend shelf-life, and displace carbon intensive single use plastics. Our transportation vehicles are safer and more efficient with strong and lightweight nanocomposite parts and panels.
ANSI: How does nano support existing and future sustainability opportunities in the consumer market?
Dr. Shatkin: As we now look to shift the economy to have a lower carbon and less resource intensive footprint, more efficient energy generation and consumption is a critical component, where our homes and cars may become generators as well as consumers of electricity, heating and cooling. Nano-enabled solar charging stations, light weighted vehicles, smarter, longer lasting, more energy efficient and reusable building products, furnishings and lighting are all developments entering the consumer products market.
How to characterize the nano-enabled components in composite materials for this diversity of technologies brings new challenges to the standards communities. In particular, the need for standards for two-dimensional materials, already widely adopted for applications in thermal management and antimicrobial surfaces, as well as advanced manufacturing approaches such as additive manufacturing of nano-enabled technologies are needed to ensure the next generation of consumer facing products are safe for consumers and for the environment.
What are some of the future areas and needs that nanotechnology standards should address?
Dr. Murashov: New standards for nanomaterials are needed in metrology, safety and health, and material specification.
In metrology, standards to adequately characterize specific commercial nanomaterials such as lipid nanoparticles and cellulosic nanomaterials and standards for specific measurement techniques such as those for characterizing particle size and shape distributions are an on-going need.
In safety and health, standards for exposure measurements and mitigation for specific nanomaterials in different environmental media and exposure scenarios are necessary for reducing risks of nanomaterials and for developing predictive model used in risk assessments.
In material specification, market continues to push for the development of material specification standards for specific nanomaterials such as graphene and carbon nanotubes. Another area of interest is to continue exploring how experience with developing standards for nanomaterials could be translated to developing standards for other advanced materials and how standards for nanomaterials could be applied to other advanced materials.
ANSI: Are these needs something that SDOs can work on now?
Dr. Murashov: The work in these areas can and should start now in order to eliminate remaining hindrances for the safe commercialization of nanotechnology advances, which is playing a crucial role in addressing the most pressing challenges that humankind is facing.
The only way to move forward with developing standards proactively is through iterative process while constantly improving and updating standards as new data are generated. This is the process that ISO TC229 has adopted and has successfully implemented. It should continue to do so for horizontal standards utilized by a broad range of commercial activities and for application-specific standards in collaboration with other standards developing organizations.
How You Can Get Involved with Nanotechnology Standards Development
As the United States National Nanotechnology Initiative's Nanotechnology Day is an annual event that features nationwide community-led events and activities to help raise nanotechnology awareness, ANSI encourages involvement in standards development that supports nanotechnology.
Read more about how ANSI’s Nanotechnology Standards Panel (ANSI-NSP) has supported the standards development that enable the safety and efficiency of nanotechnology-driven materials, products, and processes around the globe. Participation on the ANSI-NSP is open to all interested parties. Interested stakeholders can find out more via www.ansi.org/nsp.
As the U.S. member body to ISO, ANSI encourages stakeholder participation in ISO TC 229, Nanotechnologies.
Access more content about additional nanotechnology activities in a previous article.
To find out more about nanotechnology standardization participation, contact Heather Benko, senior manager, ANSI nanotechnology standardization activities, firstname.lastname@example.org.