EU-US Priorities in Nanosafety

The Policy

What it does

Creates a list of priorities for EU-US researchers in the field of nanotechnology and a means for cooperation between EU and US researchers towards fulfillment of such priorities.

Synopsis

The BILAT USA 4.0 project is an initiative funded by the European Union with a focus on fostering cooperation and facilitating innovation between researchers in the European Union and the United States of America.  The project works towards these goals through a series of workshops, one of which is titled “Fostering EU-US Cooperation in Nanosafety.”  The Fostering EU-US Cooperation in Nanosafety workshop specifically sought to enhance science, technology, and innovation (STI) partnerships by encouraging discussions relating to nanotechnology research and the safety considerations that should accompany such research.  Moreover, because of nanotechnology’s immense potential for innovation, coupled with increasing investments for its use in each of Bilat 4.0 USA’s priority areas–health, marine and arctic, nanotechnology manufacturing and processing (NMPs), and transport–there is a growing concern about the risks and hazards that accompany its use. 

As such, the nanosafety workshop had “more than 30 participants from academia, industry and policy” provide recommendations for the following two questions:

1. What should be the future research priorities in nanosafety and other advanced materials?

2. What are the opportunities for EU-US cooperation priorities in nanosafety?

The responses were then compiled for the purpose of informing both the European Commission and relevant US funding agencies about the general consensus relating to nanotechnology and nanosafety concerns and recommendations for moving forward in this area of study.  These recommendations were also meant to inform the relevant European and US agencies in preparation of Horizon 2020, which is a program focused on bridging the gap between the European Union’s public and private sectors in various areas of innovation.  Horizon 2020 will have a series of projects, one of which will focus on nanotechnologies

The Fostering EU-US Cooperation in Nanosafety workshop took place over a span of two multi-session days where participants shared information, discussed possibilities for future cooperation, and identified a list of top priorities.  The discussion also resulted in the identification of the following potential tools for advancing EU-US cooperation:

  • Twinning of existing projects
  • Exchange of young scientists and mobility of researchers
  • Participation of US in H2020 and future Horizon Europe. EPA, NIEHS, NSF and other federal agencies could fund the US participation in EU initiated nanosafety programs.
  • Establishment of joint EU-US research programs
  • Promotion of the Malta initiative (group of EU states and institutions dedicated to amending guidance to ensure nano-specific regulatory requirements are addressed) and opening such initiatives to the US
  • Future potential COST-like projects (“funding organization for the creation of research networks”)
  • Inducement prizes

A brief summary of the recommendations provided under each research priority can be found below:

Environment and human hazards

Participants agreed upon five factors that would lead to more focused and realistic assessments of environmental and human hazards posed by nanotechnology.  They indicated a need for:

  • Better screening assays;
  • Relevant endpoints;
  • Mechanistic knowledge;
  • Risk assessment categorization for nano-particles being studied or in use; and
  • Integrated approaches to toxicity assessment for human and environmental systems.

Emerging Materials

Under this priority workshop participants identified three tasks that should be carried out in order to better understand emerging materials used by nanotechnologies.  These tasks are: identifying, characterizating, and modelling of emerging (nano)materials (ENMs).  ENMs refer to nanomaterials that “present novel properties that are not exhibited in their bulk or more conventional nanoscaled counterparts.”

Social and Natural Science Research to Support Balanced Risk Governance of Emerging Materials

Participants recognize that the use of emerging materials and technologies in the field of nanotechnology is paving the way for rapid innovation, but there is a gap between the current pace of innovation and the understanding of risk posed by the use of such materials and related technology.  Thus, to better inform decision making, participants proposed an interdisciplinary approach for research related to nanotechnology.  Specifically, such an approach would involve considering “multiple metrics of risk, benefits, societal importance, manufacturing priorities and cost” in deciding how to study and utilize emerging materials.  Additionally, participants advocated for the implementation of formal decision-analytics tools to obtain broader understandings of what policies and regulations should be implemented to better understand “stakeholder needs and societal concerns . . . . [which can feasibly be] implementable on a global scale.”

Nanoinformatics

With the increasing amount of interest in nanotechnology research, the study of nanoinformatics seeks to help scientists determine which data is important and what methods and instruments are most appropriate for the collection and dissemination of data collected from such studies.  In the context of the Bilat USA 4.0 nanotechnology workshop, the focus on nanoinformatics was related to the determination of ways in which information between the EU and US could be shared and standardized.

Exposure Assessment

This priority requires those engaged in nanotechnological research to study the effects of exposure to various nanomaterials and technology and discuss how such exposures would occur in everyday settings.  Specifically, what is being sought is a better understanding of how ENMs interact with both the environment and humans over time.  By understanding how ENM life cycles affect their human and environmental interactions, scientists hope to obtain more reliable exposure characterization data which can in turn lead to more realistic hazard assessments for ENMs in various contexts.   

Standard Methods, Methodologies, Reference Material and Harmonization

The standardization goals under this priority are twofold: documentary standards and reference material.  Under documentary standards, the main goal is that data be preserved in such a way as to make the science and technology reproducible.  Under reference material the main goal is to enable labs to “have access to benchmark materials to compare results among laboratories or to use these as positive or negative controls” during research studies.

Life Cycle/Transformation/Value Chain/Stewardship

“The focus of this priority is to gain a more complete understanding of life cycle of ENM (see “Emerging Materials” heading above for definition) to support effective risk governance.”  Specifically, the concern here is that researchers are still underinformed regarding the potential environmental and human health impacts that may result from the release of nanomaterials into the environment at any time during the manufacturing, research/consumer use, or the end-of-life/disposal stage. 

 

Context

The first BILAT USA project was funded by the European Commission and developed as a means to establish strategic science and technology collaboration efforts between the EU and US across multiple disciplines.  Due to the immense interest and participation among academics, industry players, and policy experts, the BILAT USA project has since been repeated, with the BILAT USA 4.0 project representing its third iteration.  The latest project, BILAT USA 4.0, included a nanotechnology/nanosafety workshop whose two main goals were to identify future research priorities in nanosafety and opportunities for EU-US cooperation on addressing such priorities.  A principle concern among participants was the lack of “focused and more realistic hazard assessment” studies on emerging nanomaterials and nanotechnology.  After the workshop, the 30 participants from academia, industry, and policy drafted recommendations for both the European Commission and relevant US funding agencies in preparation of the upcoming Horizon Europe, a conference focused on developing problem-solving approaches to innovation-led growth within the European Union.

The recommendations that came out of the BILAT USA 4.0 project’s nanotechnology/nanosafety workshop identified 7 priority areas, which all generally related to a lack of uniformity within nanotechnology research, as well as a lack of information related to the risks posed by different nanotechnologies or nanoparticles in diverse settings.  This concern, coupled with increasing interest in the diverse potential applications of nanotechnology in various sectors, prompted the participants to focus on ways in which EU and US researchers could assess the risks posed by such technologies in more standardized and collaborative ways moving forward.  Some ideas included the use of standardized methods and reference materials to speed up nanotechnology development, while ensuring quality control.  With greater standardization and collaboration, the hope is that researchers will be better able to understand the toxicological effects and risks posed by novel uses of nanotechnology in the future.

The Science

Science Synopsis

Nanotechnology refers to “science, engineering, and technology conducted at the nanoscale, which is about 1 to 100 nanometers.”  Interest in nanotechnology has grown over the past years given its potential to make materials “stronger, lighter, more durable, more reactive, more sieve-like, or better electrical conductors, among many other traits.”   Nanotechnology has the potential to improve and revolutionize a wide variety of industry sectors, including but not limited to, medicine, transportation, energy, food safety, and environmental science.  But with growing interest in Nanotechnology from the private sector, there are growing concerns about the potential human health and environmental risks posed by the proliferation of such technology.  Nanoparticles have increased mobility and reactivity due to their increased surface area  to volume ratio, allowing them to perform “almost magical feats of conductivity, reactivity, and optical sensitivity, among others.”  However, the toxicity of such materials cannot be based off the known toxicity of the corresponding macro-sized or “normal-sized” materials, because the nanoparticle versions do not interact in the same way with their environments as do their macro-sized counterparts.  

Thus, despite the potential upside of nanotechnologies, two of the main concerns related to the use of nanotechnology deal with potential health and environmental hazards that may result from their use.  In terms of health risks, nanoparticles may enter the body via four routes: inhalation, digestion, absorption, or injection.  Once inside the body, nanoparticles are highly mobile and have the ability to cross the blood-brain barrier.  As such, there is a concern that nanoparticles may trigger overwhelming immune reactions or accumulate in the body and affect the regulatory mechanisms of enzymes and proteins in unforeseen ways.

As for environmental risks, experts worry about the potential air, water, and soil pollution that may result from the widespread use of engineered nanoparticles.  Moreover, the ability of nanoparticles to aggregate and change behavior upon aggregation has caused many, including the Environmental Protection Agency (EPA), to be concerned about the potential negative effects on the environment and different ecosystems.  Thus, the scientific community has indicated a need to continue understanding the real risks, if any, that are posed to human health and the environment by increasing nanotechnology use.

 The absolute surface area isn’t increased, just the surface area to volume ratio. 

Scientific Assumptions

The most basic overarching scientific assumption in the EU-US Priorities in Nanosafety Report is that environmental or human hazards can result from the use of nanotechnologies.  This assumption has been supported by specific studies on certain nanomaterials, for example  nanosilver studies that have linked nanosilver particle exposure to toxic effects on both human health and the environment.  However, some more specific assumptions within a couple of the identified priority areas include:

  • Environment and Human Hazards
    • Assumptions that high throughput, predictive screening assays and functional assays can accurately predict risk. This assumption has been supported  through studies conducted on ENMs that have documented the effects of specific nanomaterials on certain biological or ecological systems.
    • Assumptions that mechanistic-based hazard assessments focused on classic toxicity endpoints are insufficient.  This assumption has been supported through studies emphasizing the need for better mechanistic insights into toxicity pathways, in light of the current shortcomings in mechanistic based methodologies.
    • Assumptions that there are linkages between nanomaterial properties and toxicological outcomes.  This assumption has also been supported by studies linking nanomaterial properties to toxicological outcomes, as shown in the case of nanosilver studies.

 


The Debate

Scientific Controversies / Uncertainties

Much of the controversy surrounding nanotechnology/nanosafety deals with how this field of study should be handled and what researchers should be focused on.  For example, one basic concern is whether current laws applicable to other scientific industries may be relied upon in the context of nanotechnology, or whether existing regulatory frameworks are ill-equipped to handle specific concerns unique to nanotechnology research.  If they are ill-equipped then there is a debate about what the regulatory framework should look like.  This is in part, a motivation behind the BILAT USA 4.0 conference which sought to establish an interdisciplinary and international approach to solving this inquiry. 

More specifically, there is also controversy relating to the possible negative health effects of nanoparticles on both individuals and the environment.  Some researchers feel that the perceived risks of nanotechnology have been overblown and worry that continuing to proceed in this fashion will only hamper the trajectory of current nanotechnology research and potential future applications.    However, the BILAT USA 4.0 conference represents an approach that wants to understand the risks associated with nanotechnology use to better inform future applications.

 

 

Potential Impacts

The EU-US Priorities in Nanosafety Report will likely be utilized as a tool to help inform researchers in both the EU and US about what information should be researched moving forward in the field of nanotechnology.  Researchers may shift their focus towards the risks associated with various nanomaterials in diverse settings.  However, because this is not a binding document, researchers may reference the document and give it some consideration but will likely not shift their research priorities based on this report without clear government intervention.

Because this report is meant to inform the upcoming Horizon Europe programme, there is likely a greater chance that the findings of this report will influence policy change in the EU before the US.  However, it remains to be seen what the full extent of the effect of the EU-US Priorities in Nanosafety Report will be and whether a future BILAT USA project workshop on nanotechnology/nanosafety will identify any changes that resulted from its dissemination.