What are “Advanced Materials”? what might be considered by some in the automotive industry as an advanced material might not be considered “advanced” in the aerospace industry. Is there an international standard definition for Advanced Materials?
In August ANSI (The American National Standards Institute) organized a Workshop on “Advanced Materials”. Following this workshop, AMPT formed a Sub Working Group to develop a consensus-based definition for advanced materials as it pertains to the interests of the AMPT stakeholders.
Kazi Tasneem a member of the Applied Public Health and EHS and the Terminology working group at AMPT attended the ANSI workshop.
Below are her notes from the meeting. These notes are not reflective of the AMPT or Kazi’s personal position but rather indicative of the diversity of opinion and stakeholders from regulatory agencies, internationals standard bodies, material producers and member organizations such as AMPT. Since the workshop more dialogue sessions have been held to navigate some of the concerns and issues noted below.
- Advanced materials are complicated to define unambiguously, as they are transient in nature and seem to have no characteristic that is common to all of them; this is a challenge for developing specific legislation.
- Confusion with the terminologies – Nano, bio, micro, smart materials. New terminology, metrology, toxicity, matrix for material on how to use those for application, compatible with the system.
- Since advanced material can be defined as materials with novel or enhanced properties that are not size-dependent (for example quantum materials such as bulk topological insulators), then nanomaterials are overlapping with advanced material on a Venn diagram rather than being a subset of advanced materials, ore precise by stating that "engineering nanomaterials are a subset of advanced materials".
- Hazard and risk-related approaches: Focus on materials with unique, novel and emergent properties rather than an arbitrary size scale by expanding scopes to include advanced/emerging materials
- Data sharing can reduce the risk associated with nanomaterial use by knowledge sharing among partnership institution. The use of language is also important to describe the fate and transport of nanomaterials before dissemination of the information.
- Do newly emerging materials have new material properties that need to be considered for toxicity assessment? Internal structures (composition, structure) that might be “nano” even if the end product does not fit the official nano designation. In the past, “nano” was based almost entirely on size as the dominant factor controlling the materials properties at the small length scale. And it is considered that the small length scale brings unique health and safety impact.
- Emerging industrial materials are more frequently using complex chemical composition/structuring along with physical nano-structuring. There is a gap in understanding materials in which the chemical and physical structures together lead to emergent new properties – as such, amorphous materials properties, emergent compositions, computational prediction of properties of non-crystalline/complex materials. Heterogeneity in the compositions, including materials beyond >100 nm with potential risks not solely determined by chemical composition, but may be additionally strengthened by physical and morphological properties.
- The key challenge here is that the degree of chemical complexity increases, the feasibility of testing individual materials rapidly becomes intractable. So, one needs to move beyond testing of specific materials to a paradigm based on mechanistic understanding of the biological responses and looking for how these responses are similar/different for broader classes of materials. So that means the molecular biology community need to be involved.
- Understanding the materials properties and toxicity is the critical goal but it needs to be treated with care not to constrain trade
- We need clear definition of what constitute advanced materials
- In vitro and in vivo approaches to Hazard identification of new materials (more human based safety studies)
- Hazard and risk-related approaches: Focus on materials with unique, novel and emergent properties rather than an arbitrary size scale by expanding scopes to include advanced/emerging materials
- Need to limit the scope – exclude bulk materials, incidental nanoparticles, biomacromolecules, traditional materials
- Need to attract additional expert.
Some existing regulatory framework
ISO/TC 229 Nanotechnologies, E56 standards
Most E56 standards and work items are not extensible to other types of advanced materials.
- Test method are mostly material specific
- Specific sample preparation
- Size limited measurement method
ISO TC229: Typically, but not exclusively below 100 nanometers, Size dependent phenomena
Ongoing activities:
- Standardization of the characteristics and test methods
o Porous alumina or silica
- Performance based standards
o Biomedical applications: biosensor
International perspective from Europe and OCED
- Advanced materials are covered by EU legislations on chemicals, but are not explicitly mentioned or defined in the chemical legislation. The legislation is supported by risk/safety assessment tools for assessing issues for one substance at a time, and rarely deal with mixtures and synergistic/antagonistic issues or the dynamic nature of some materials, such as, smart nanomaterials.
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Since September 2020, the AMPT Terminology Sub-WG has developed the following definition and is now soliciting input and review from other stakeholders.
If you'd like to get share your opinion and position, you can visit the Sub-WG page: Click Here
Kazi obtained her doctorate in Chemical and Biomolecular Engineering from Vanderbilt University in 2021. She has extensive experience in chemical/environmental toxicity studies as well as modelling in vitro drug delivery and transport in organ-on-chip systems. She is now working as a scientist at Genentech.
What are “Advanced Materials”? what might be considered by some in the automotive industry as an advanced material might not be considered “advanced” in the aerospace industry. Is there an international standard definition for Advanced Materials?
In August ANSI (The American National Standards Institute) organized a Workshop on “Advanced Materials”. Following this workshop, AMPT formed a Sub Working Group to develop a consensus-based definition for advanced materials as it pertains to the interests of the AMPT stakeholders.
Kazi Tasneem a member of the Applied Public Health and EHS and the Terminology working group at AMPT attended the ANSI workshop.
Below are her notes from the meeting. These notes are not reflective of the AMPT or Kazi’s personal position but rather indicative of the diversity of opinion and stakeholders from regulatory agencies, internationals standard bodies, material producers and member organizations such as AMPT. Since the workshop more dialogue sessions have been held to navigate some of the concerns and issues noted below.
- Advanced materials are complicated to define unambiguously, as they are transient in nature and seem to have no characteristic that is common to all of them; this is a challenge for developing specific legislation.
- Confusion with the terminologies – Nano, bio, micro, smart materials. New terminology, metrology, toxicity, matrix for material on how to use those for application, compatible with the system.
- Since advanced material can be defined as materials with novel or enhanced properties that are not size-dependent (for example quantum materials such as bulk topological insulators), then nanomaterials are overlapping with advanced material on a Venn diagram rather than being a subset of advanced materials, ore precise by stating that "engineering nanomaterials are a subset of advanced materials".
- Hazard and risk-related approaches: Focus on materials with unique, novel and emergent properties rather than an arbitrary size scale by expanding scopes to include advanced/emerging materials
- Data sharing can reduce the risk associated with nanomaterial use by knowledge sharing among partnership institution. The use of language is also important to describe the fate and transport of nanomaterials before dissemination of the information.
- Do newly emerging materials have new material properties that need to be considered for toxicity assessment? Internal structures (composition, structure) that might be “nano” even if the end product does not fit the official nano designation. In the past, “nano” was based almost entirely on size as the dominant factor controlling the materials properties at the small length scale. And it is considered that the small length scale brings unique health and safety impact.
- Emerging industrial materials are more frequently using complex chemical composition/structuring along with physical nano-structuring. There is a gap in understanding materials in which the chemical and physical structures together lead to emergent new properties – as such, amorphous materials properties, emergent compositions, computational prediction of properties of non-crystalline/complex materials. Heterogeneity in the compositions, including materials beyond >100 nm with potential risks not solely determined by chemical composition, but may be additionally strengthened by physical and morphological properties.
- The key challenge here is that the degree of chemical complexity increases, the feasibility of testing individual materials rapidly becomes intractable. So, one needs to move beyond testing of specific materials to a paradigm based on mechanistic understanding of the biological responses and looking for how these responses are similar/different for broader classes of materials. So that means the molecular biology community need to be involved.
- Understanding the materials properties and toxicity is the critical goal but it needs to be treated with care not to constrain trade
- We need clear definition of what constitute advanced materials
- In vitro and in vivo approaches to Hazard identification of new materials (more human based safety studies)
- Hazard and risk-related approaches: Focus on materials with unique, novel and emergent properties rather than an arbitrary size scale by expanding scopes to include advanced/emerging materials
- Need to limit the scope – exclude bulk materials, incidental nanoparticles, biomacromolecules, traditional materials
- Need to attract additional expert.
Some existing regulatory framework
ISO/TC 229 Nanotechnologies, E56 standards
Most E56 standards and work items are not extensible to other types of advanced materials.
- Test method are mostly material specific
- Specific sample preparation
- Size limited measurement method
ISO TC229: Typically, but not exclusively below 100 nanometers, Size dependent phenomena
Ongoing activities:
- Standardization of the characteristics and test methods
o Porous alumina or silica
- Performance based standards
o Biomedical applications: biosensor
International perspective from Europe and OCED
- Advanced materials are covered by EU legislations on chemicals, but are not explicitly mentioned or defined in the chemical legislation. The legislation is supported by risk/safety assessment tools for assessing issues for one substance at a time, and rarely deal with mixtures and synergistic/antagonistic issues or the dynamic nature of some materials, such as, smart nanomaterials.
-----------------------------------------------------------------------
Since September 2020, the AMPT Terminology Sub-WG has developed the following definition and is now soliciting input and review from other stakeholders.
If you'd like to get share your opinion and position, you can visit the Sub-WG page: Click Here
Kazi obtained her doctorate in Chemical and Biomolecular Engineering from Vanderbilt University in 2021. She has extensive experience in chemical/environmental toxicity studies as well as modelling in vitro drug delivery and transport in organ-on-chip systems. She is now working as a scientist at Genentech.