DEPARTMENTS
PRODUCT STEWARDSHIP
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Nanomaterial Stewardship
Acknowledgment: This article was drawn mainly from Nanomaterial Stewardship Guidance sponsored by the AIHA Nanotechnology Working Group (NTWG) and represents a compilation of information from NTWG members and others. Major contributors were Renae Goldman, CIH, FAIHA, John Baker, CIH, Charles Geraci, PhD, CIH, FAIHA, Michele Shepard, PhD, CIH, John Lowe, CIH, and Christine Knezevich, CIH. Disclaimer: This article represents the views of the author and not 3M Company, and is not intended as legal advice. Nanomaterial regulation is complex and rapidly evolving. Readers should consult their legal and regulatory subject matter experts.


While nanomaterials hold great promise to enhance technologies and products, managing their potential exposures and health risks is challenging, especially since the science and regulation of nanomaterial health risks continues to evolve. Through product stewardship, industrial hygienists and EHS professionals can ensure that potential environmental, health, safety, and regulatory impacts are addressed and responsibly managed throughout the product life cycle. The skills for assessing and managing occupational risk can complement and support product stewardship, including stewardship for nanomaterials and nanoproducts.

One product stewardship activity with much recent emphasis is sustainable product design and development. A life-cycle approach to sustainability ensures potential EHS and regulatory impacts are considered early in product and process design and development; addressed in product design, raw material selection, manufacture (including distribution operations), use (including maintenance), re-use, recycle, and disposal; and reassessed periodically and when new information becomes available.
This iterative review is especially important for emerging technologies since the science and regulations may still be evolving. To address overall sustainability, relevant ethical, legal, and societal aspects should also be considered. RAW MATERIALS FROM SUPPLIERS It’s important to have a process in place to systematically determine whether nanoscale ingredients are present in materials or products received from suppliers. Request that suppliers disclose nano content in their raw materials—for example, ask whether their materials contain any nanomaterials with a primary particle size from 1 to 100 nanometers. Enlist purchasing and product developers to alert the product steward and other EHS professionals, as appropriate, when there is intentional nanomaterial content in new product formulations. Review specification sheets, certificates of analysis, and other technical information for materials with potential for nano-content. Be aware that labels and safety data sheets (SDSs) often do not accurately reflect nanomaterial content or hazards. SAFER DESIGN It may be possible to design (or select) safer nanoparticles by choosing or altering their properties. It may also be possible to reduce the amount of a hazardous nanomaterial needed to obtain the desired functionality. Understanding characteristics of nanomaterials to reduce toxicity is an active field of research, as is the merging of green chemistry concepts with nanoscience.
A producer of nanoparticles, nanomaterials, or nanoproducts may be able to develop safer synthesis or processing techniques or adopt existing methods to reduce material hazard and potential for worker exposure. Approaches that may reduce risk include bottom-up synthesis methods free of hazardous catalysts and the use of nanoparticles in liquid suspension rather than in dry powder form.
If a nanoparticle product is dispersive, it may be possible to reduce dispersion potential either by fixing the nanoparticles to other “support” ingredients or by modifying other ingredients that affect the dispersive nature. If nanoparticles are fixed in a product, the product design could focus on reducing release of those nanoparticles during the product life cycle—for example, from wear, decomposition or corrosion during use, from abrasion during cleaning, or from grinding or shredding during recycling or disposal. REGULATORY LANDSCAPE Regulations that affect stages of the nanoproduct life cycle influence several product stewardship activities. Many countries have relied upon existing regulations to provide oversight for nanoparticles, nanomaterials, and nanoproducts. Some countries have either incrementally amended certain regulations, as the European Union has done for cosmetics, food and food packaging, and pesticides/biocides, or provided guidance for addressing nanomaterials with existing regulations.
Original nano-specific regulations typically require annual reporting of nanomaterials or nanoproducts into national inventories or registries to enable identification and tracking, and sometimes to prioritize future research or regulation. The country-by-country, and sometimes agency-by-agency, approach to regulation can result in complex compliance challenges. This is particularly true for companies whose nanomaterials or nanoproducts are manufactured, imported, distributed, or processed in multiple countries, and for companies whose nanomaterials are used in a variety of applications, markets, and sectors covered by different agency jurisdictions.
Labels and safety data sheets (SDSs) often do not accurately reflect nanomaterial content or hazards.
RENAE GOLDMAN, MS, CIH, FAIHA, is corporate industrial hygiene specialist at 3M Company in Saint Paul, Minn. She can be reached at (651) 737-3496 or via email.
Product stewards and other EHS professionals should identify which regulations apply to nanomaterials and nanoproducts they are responsible for (consider state and local as well as national regulations); understand the requirements in detail; and closely monitor the regulatory landscape for changes and new requirements potentially affecting commercialization.
EPA’s “Reporting and Recordkeeping Rule for Nanoscale Materials” in Section 8(a) of the Toxic Substances Control Act (TSCA) applies to manufacturers and processors of nanoscale materials. Requirements include electronic reporting of chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing data on environmental and health effects for existing nanomaterials and for new discrete nanoscale materials before they are manufactured or processed. The rule's effective date is to be determined.
Among EU member states, France, Belgium, Denmark, and Norway have enacted nano reporting regulations, and Sweden is developing requirements. Some of these regulations cover only nanoparticle form, while others also cover mixtures or articles. Some exempt pigments, while another has a long list of exemptions. A table illustrating the main features of these regulations is available on the website of the European Union Observatory for Nanomaterials.
Hazard communication regulations in many countries require manufacturers and importers to provide information about hazards and safe use for hazardous materials (typically at or above a designated percentage of composition) to downstream employers via SDSs. Neither the OSHA Hazard Communication Standard nor the European Union REACH and CLP regulations contain provisions specific to hazardous nanomaterials, but the definition of a chemical substance covers nanomaterials even if they are not specifically mentioned in the regulations.
Ensuring compliance with regulations is necessary for good product stewardship, but regulations for emerging technologies may not exist or keep up with the pace of innovation. Authoritative agencies, industry associations, and other stakeholders have developed various consensus standards and voluntary guidelines that may help inform nano-product stewardship activities. PRODUCT EXPOSURE AND RISK MANAGEMENT Many guidance documents and tools have been developed to help assess and control worker exposure to nanoparticles, which in some cases may have a hazard profile different from that of larger particles of similar composition. Some of this guidance is also relevant for producers of nanomaterials and nanoproducts that are striving to understand potential risk to downstream users and determine appropriate risk management measures prior to commercialization.
IH and OHS professionals are familiar with the challenges of conducting exposure and risk assessment of nanomaterials in the workplace. These include insufficient characterization of nanoparticle content, insufficient toxicity data to assess health hazards, and uncertainty regarding an appropriate exposure metric. Some of these challenges will also affect upstream suppliers of nanoparticles, nanomaterials, and nanoproducts who assess hazard and potential for exposures during other phases of the product life cycle.
Given these challenges, studies of nanoproduct exposures and risk assessment often focus on the apparently simpler question of whether nanoparticles may be released during use, maintenance, recycling, or disposal. But even this approach can be quite complex. AIHA’s nanomaterial stewardship guidance (PDF) addresses additional considerations for understanding nanoproduct risk.
Standards and best practices are often the basis for regulation, and this has certainly been true for protection of workers handling nanomaterials. The challenges described in this article can serve IHs as starting points for discussion with other partners. IHs have, or can develop, the skills and experience needed to support product stewardship for nanomaterials at all stages of a nanoproduct’s life cycle.

RESOURCES Visit the AIHA NTWG web page for additional resources.

AIHA: Nanomaterial Stewardship (PDF, March 2017).
European Commission Joint Research Centre Science and Policy: Considerations on Information Needs for Nanomaterials in Consumer Products (PDF, April 2014).

European Union Observatory for Nanomaterials: “Nanomaterials.”
Journal of Nanoparticle Research: “Perspectives on the Design of Safer Nanomaterials and Manufacturing Processes” (PDF, September 2015).
NIOSH: Building a Safety Program to Protect the Nanotechnology Workforce: A Guide for Small to Medium-Sized Enterprises (PDF, March 2016).
The Synergist: “Soft Law and Nanotechnology” (April 2016).