Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

Germany Publishes Review of the Joint Research Strategy of the Higher Federal Authorities

Posted in EU Member State, International, Legal/Regulatory Issues, Research

Germany Publishes Review of the Joint Research Strategy of the Higher Federal Authorities

 

On September 19, 2016, the Federal Institute for Occupational Safety and Health (BAuA) published a report entitled Review of the joint research strategy of the higher federal authorities — Nanomaterials and other advanced materials:  Application safety and environmental compatibility.  The report states that in a long-term research strategy, the higher federal authorities responsible for human and environmental safety — the German Environment Agency (UBA), the Federal Institute for Risk Assessment (BfR), BAuA, the Federal Institute for Materials Research and Testing (BAM), and the National Metrology Institute (PTB) — are accompanying the rapid pace of development of new materials from the points of view of occupational safety and health, consumer protection, and environmental protection.  The report states that the goals of application safety and environmental compatibility for advanced materials and derived products are intended to reduce significantly unacceptable risks to humans and the environment.  According to the report, this can be achieved by:

  1. Using safe materials without hazardous properties for humans and the environment (direct application safety); or
  2. Product design for low emissions and environmental compatibility over the entire product lifecycle (integrated application safety); or
  3. Product stewardship, where producers support users in taking technical, organizational, and personal safety measures for the safe use and disposal of products (supported application safety).

As a comprising part of the federal government’s Nanotechnology Action Plan 2020, the update of the joint research strategy aims to contribute to governmental research in the following main areas:

  • Characterizing and assessing the human and environmental risks of advanced materials;
  • Supporting research institutions and business enterprises;
  • Science-based revision of legal requirements and recommendations; and
  • Public acceptance.

The report states that the research strategy will be implemented in projects and other research-related activities, including governmental research, tendering and extramural research funding, and participation in mostly publicly supported projects with third-party funding.  Agencies will use interdisciplinary and transdisciplinary approaches to connect better risk and safety research with innovation research and material development.  To keep up with the pace of development, the time horizon for the research strategy extends to 2020.  The research objectives in the report address the research approaches likely to be actionable in this period.  The research strategy will be supported by a working group and be evaluated and revised by the end of the Nanotechnology Action Plan 2020.

EPA Researches How Sunscreens Containing Engineered Nanomaterials Might Change When Exposed to Chemicals in Pool Water

Posted in Federal, Research, United States

An August 15, 2016, U.S. Environmental Protection Agency (EPA) blog item describes EPA’s research on sunscreens containing engineered nanomaterials and how they might change when exposed to chemicals in pool water.  According to EPA, many sunscreens contain titanium dioxide engineered nanomaterials, which are often coated with other materials such as aluminum hydroxide to shield skin from reactive oxygen species.  EPA researchers are testing to see whether swimming pool water degrades the aluminum hydroxide coating, and if the extent of the degradation is enough to allow the production of potentially harmful reactive oxygen species.  Results show that after three days, pool water caused the aluminum hydroxide coating to degrade, which can reduce the coating’s protective properties and increase the potential toxicity.  EPA notes that even with degraded coating, the toxicity measured from the coated titanium dioxide was significantly less than the uncoated material, and “these sunscreens still provide life-saving protection against UV radiation.”  According to EPA, the study provides evidence that when released into the environment, nanomaterials undergo physical and/or chemical transformations — “an important consideration when measuring the impact of these materials on public health and the environment.”

NNCO Will Hold Webinar on Nanotechnology and the Insurance Industry

Posted in Federal, United States

On September 22, 2016, the National Nanotechnology Coordination Office (NNCO) will hold a webinar on the insurance industry and the challenges of underwriting nanotechnology and other emerging technologies.  NNCO Director Dr. Michael Meador will moderate the webinar discussion.  Speakers will include:

  • Allen Gelwick, Executive Vice President of the Lockton Companies;
  • Christie Sayes, Associate Professor of Environmental Science and Toxicology at Baylor University;
  • David Swatzell, Managing Partner at Knowtional; and
  • Madhu Nutakki, Digital Chief Technology Officer, Innovation & Mobile Delivery, at AIG.

NNCO encourages representatives of the insurance industry, the nanotechnology business community, and interested members of the general public, media, academia, industry, non-governmental organizations, and federal, state, and local governments to participate.  Questions for the panel can be submitted to webinar@nnco.nano.gov through the end of the webinar at 2:00 p.m. on September 22, 2016.  The webinar is free and open to the public with registration on a first-come, first-served basis.  Registration will be capped at 500.

Draft 2016 NNI Strategic Plan Available for Public Comment

Posted in Federal, Legal/Regulatory Issues, United States

On September 13, 2016, the National Nanotechnology Initiative (NNI) announced in the Federal Register the availability of the draft 2016 NNI Strategic Plan for public comment.  The NNI Strategic Plan represents a consensus among NNI agencies on the high-level goals and priorities of the NNI, and on specific objectives to be pursued over at least the next three years.  The NNI Strategic Plan provides the framework under which individual NNI agencies conduct their own nanotechnology programs, coordinate activities with those of other NNI agencies, and collaborate.  The draft 2016 NNI Strategic Plan states that over the life of the NNI, its focus has broadened from investments in foundational research in nanomaterials and nanotechnology-enabled devices to include activities concerning how these nanomaterials and devices can be incorporated into nanotechnology-enabled systems.  This update of the Strategic Plan “reflects that evolution and addresses how the NNI agencies will collaborate with each other and the broader nanotechnology community to expand the ecosystem that supports fundamental discovery, fosters innovation, and promotes the transfer of nanotechnology discoveries from lab to market.”  It includes the following goals:

  1. Advance a world-class nanotechnology research and development program;
  2. Foster the transfer of new technologies into products for commercial and public benefit;
  3. Develop and sustain educational resources, a skilled workforce, and a dynamic infrastructure and toolset to advance nanotechnology; and
  4. Support responsible development of nanotechnology.

Comments are due September 23, 2016.

National Academies Publishes Prepublication Version of Triennial Review of the NNI

Posted in Federal, Legal/Regulatory Issues, United States

In early September 2016, the National Academies published a prepublication version of the Triennial Review of the National Nanotechnology Initiative.  The National Nanotechnology Coordination Office (NNCO) asked the National Research Council (NRC) to conduct a triennial review of the National Nanotechnology Initiative (NNI).  In particular, the NRC was asked to assess:  (1) mechanisms to advance focused areas of nanotechnology toward advanced development and commercialization; and (2) the physical and human infrastructure needs for successful realization in the U.S. of the benefits of nanotechnology development.  According to the report, the NNI “not only needs to invest in research and discovery, it needs to focus on translating research results into commercial products.”  The report assesses NNI mechanisms to advance focused areas of nanotechnology towards advanced development and commercialization, with particular attention to advancing nanomanufacturing (Chapters 2 and 3) and the adequacy of the physical and human infrastructure (Chapters 4 and 5) to support research as well as private sector innovation.  The report concludes that the NNI, including the interagency bodies and the NNCO, “continues to add value to the portfolio of activities across participating agencies.”  Looking ahead, the report recommends that the NNI can significantly increase that value by focusing on research that will enable progress and success in other advanced technology areas of priority, especially advanced manufacturing.  At the same time, the report states, the NNI agencies “are called on to sustain investment in and facilitate access to physical infrastructure and to take steps to realize the full value of educational materials and programs.”  In the course of identifying targeted areas in which to focus, NNI agencies have the opportunity to consider the NNI’s goals and the criteria for continuing to invest resources in its coordination and management.

EC Requests Scientific Opinion on Styrene/Acrylates Copolymer (Nano) and Sodium Styrene/Acrylates Copolymer (Nano)

Posted in International, Legal/Regulatory Issues

The European Commission (EC) requested a scientific opinion from the Scientific Committee on Consumer Safety (SCCS) on styrene/acrylates copolymer and sodium styrene/acrylates copolymer in nano forms.  Under the Cosmetics Regulation, any cosmetic product containing a nanomaterial must be notified to the EC six months prior to being placed on the market.  If the EC has concerns about the safety of the nanomaterial, it will refer it to the SCCS for a full risk assessment.  According to the EC, it has received eight notifications of cosmetic products containing styrene/acrylates copolymer and sodium styrene/acrylates copolymer in nano forms.  The EC states that, according to the applicants, the ingredients are used in nano coated form in leave-on cosmetic products with a maximum reported concentration limit of 0.06 percent and specifications as reported in the list appended to the EC’s request.  The EC states that it has concerns on the use of sodium styrene/acrylates copolymer (nano) and styrene/acrylates copolymer (nano) because of the potential for nanoparticles to be absorbed and enter into the cells.  The EC’s request to the SCCS lists the following questions:

  • In view of the above, and taking into account the scientific data provided, the SCCS is requested to give its opinion on the safety of the nanomaterial styrene/acrylates copolymer and sodium styrene/acrylates copolymer when used in leave-on cosmetics products with a maximum concentration limit of 0.06 percent, taking into account the reasonably foreseeable exposure conditions; and
  • The SCCS is requested to address any further scientific concerns with regard to the use of styrene/acrylates copolymer and sodium styrene/acrylates copolymer in nano form in cosmetic products.

The SCCS’s scientific opinion is due six months from receipt of the EC’s request.

Synopsis Available for 2016 U.S.-EU: Bridging NanoEHS Research Efforts Joint Workshop

Posted in International, Research, United States

The synopsis is available for the June 6-7, 2016, U.S.-European Union (EU) Nano Environmental and Health Safety (NanoEHS) Research Efforts joint workshop.  According to the synopsis, the first day of the workshop was devoted to an interactive nanoEHS scrimmage in which the groups collectively responded to a spill of a hypothetical nanotechnology-enabled product.  U.S.-EU Communities of Research (COR) representatives planned the scrimmage, and the highlights and findings from the scrimmage are expected to be reported in the scientific literature.  The synopsis states that the rest of the workshop included plenary presentations and discussions, as well as breakout sessions in which each of the seven CORs met to discuss accomplishments and set priorities and plans for the coming year.  The final plenary session was an open discussion where the need to assess the current state of nanoEHS knowledge emerged as a significant priority for the entire community.  According to the synopsis, several participants noted that “this is a substantial and complex task to undertake, but that the CORs are uniquely positioned to contribute to such an activity.”  The synopsis includes summaries of the COR breakout sessions:

  • Characterization COR: Discussions during the Characterization COR breakout session highlighted how issues of poor data quality and reproducibility can negatively impact research and translation in areas as diverse as nanoEHS and biomedicine.
  • Databases and Computational Modeling for NanoEHS COR: The conversations in the Databases and Computational Modeling for NanoEHS COR breakout session touched on key findings from the nanoEHS scrimmage, including the utility of the mock safety data sheets (SDS).  According to the synopsis, the SDSs were generally regarded as helpful, but “[n]otably, the scrimmage participants assumed that the SDSs were valid, and the data supporting the SDS were not examined.”
  • Human Toxicity COR: The following improvements for future scrimmages were suggested:  documenting the wide range of opinions in response to the scrimmage scenario; giving each COR different starting information; and focusing more on the nanotechnology-specific aspects of the materials.  As an idea for the next scrimmage, participants suggested looking at common consumer products (g., sunscreen, antimicrobial textiles, carbon nanotubes in electronics) to determine if there is agreement among the CORs on exposure implications, as well as on potential impacts on human health or the environment.
  • Ecotoxicity COR: The two main topics discussed during the Ecotoxicity COR breakout session were quantification of nanomaterials in organism tissues after ecotoxicology testing and more environmentally relevant ecotoxicity testing.
  • Exposure through Product Life COR: Breakout session attendees brainstormed possible focus areas for the COR to address, with the following high-level needs emerging:  (1) data on chronic exposures to engineered nanomaterials; (2) information on scenarios in which engineered nanomaterials may be released from consumer products; and (3) methods to detect and quantify rapidly engineered nanomaterials in products at levels of potential exposure concern.
  • Risk Assessment COR: Participants discussed the lessons learned from the nanoEHS scrimmage, with the primary conclusions that:  (1) differences exist between risk assessment reference documents, governance, and communication across the U.S. and Europe; and (2) differences exist between the scientific assessment of risk carried out within this research community and the short-term evaluation and management processes required for successful management and communication of emergency situations.
  • Risk Management and Control COR: Ulla Vogel, EU Co-Chair, described the potential routes of worker exposure as inhalation, ingestion, and dermal and noted that inhalation is considered the major route of occupational concern for nanomaterials.  U.S. Co-Chair Dr. Vince Castranova gave a presentation on “Proposed Amendments to [Organization for Economic Cooperation and Development (OECD)] Subacute and Subchronic Inhalation Test Guidelines.”  According to Castranova, two changes appear likely:  (1) the current limit for mass median aerodynamic diameter (MMAD) may change from the current 1-4 micrometers (μm) limit to less than 2 μm; and (2) the current biological analysis of pulmonary response may change from histopathology alone to histopathology plus analysis of damage and inflammatory markers in bronchoalveolar lavage samples.  Further, it appears that measurement of lung burden and clearance of pulmonary nanoparticles will be recommended as optional.

Global Summit on Regulatory Science Will Focus on Nanotechnology Standards and Applications

Posted in Federal, International, Legal/Regulatory Issues, United States

The 2016 Global Summit on Regulatory Science (GSRS) will be held September 7-9, 2016, in Bethesda, Maryland.  Each GSRS meeting focuses on an area of regulatory science that would benefit from discussions aimed at identifying future research directions, and this GSRS meeting will focus on nanotechnology standards and applications, building on an October 11, 2015, GSRS workshop.  The 2015 workshop focused on physico-chemical measurements and standards relevant to nanomaterials in the “pristine state” and in complex matrices.  This meeting will expand on that focus to include both physico-chemical and biological measurements and standards for specific applications, namely nanomaterial-containing drugs, medical devices, food and food contact materials, and personal care products.  The goals of the meeting are to:

  • Educate a broad group of stakeholders on the state of the art in nanotechnology science, measurement methods, and standards for regulatory applications;
  • Identify the most immediate needs in nanotechnology science, measurement methods, and standards relevant to regulatory applications; and
  • Facilitate greater coordination between stakeholders in the development of standards.

The desired outcomes of the meeting include:

  • Publication of a meeting report: Information generated by the brainstorming panel sessions will be summarized to capture and prioritize needs for new consensus-based documentary standards, guidance documents, and reference materials specifically targeted for regulatory applications of nanotechnology products.  Similarly, state-of-the-art and existing gaps in nanotechnology regulatory science will be addressed across a broad spectrum of applications.  This information will be incorporated in a publicly available report; and
  • Global consensus for a centralized website: There are a number of websites that contain information on standards, for example, the Nanotechnology Standards Database hosted by the American National Standards Institute.  A new, centralized website containing links to existing lists of international standards is needed to consolidate the information in a single location.  It could be examined whether this website can be part of the European Union’s Nanomaterials Observatory to be established and hosted by the European Chemicals Agency.

The read-ahead material is a 26-page document listing U.S. and international regulatory agency guidance documents, documents from other organizations, documentary standards, publicly available protocols, and nanoscale reference materials.

EC Requests Scientific Opinion on Colloidal Silver (Nano)

Posted in International, Legal/Regulatory Issues

The European Commission (EC) has requested a scientific opinion from the Scientific Committee on Consumer Safety (SCCS) on colloidal silver (nano). Under the Cosmetics Regulation, any cosmetic product containing a nanomaterial must be notified to the EC six months prior to being placed on the market.  If the EC has concerns about the safety of the nanomaterial, it will refer it to the SCCS for a full risk assessment.  According to the EC, it has received 63 notifications of cosmetic products containing colloidal silver in nano form.  The EC states that, according to the applicants, colloidal silver is used in nano uncoated form both in leave-on and rinse-off oral cosmetics products, including toothpastes and skin care products with a maximum reported concentration limit of one percent and specifications as reported in the EC’s request.  The EC states that it has concerns on the use of colloidal silver in nano form because of the potential for nanoparticles to be absorbed and enter into the cells.  The EC requests the SCCS conduct a safety assessment of the nano form of colloidal silver covered in the notifications listed in the annex to its request, in the above-mentioned categories of products, taking into account the reasonably foreseeable exposure conditions.

  1. In view of above, and taken into account the scientific data provided, the SCCS is requested to give its opinion on the safety of the nanomaterial colloidal silver when used in cosmetics, including toothpastes and skin care products with a maximum concentration limit of one percent, taking into account the reasonably foreseeable exposure conditions; and
  2. The SCCS is requested to address any further scientific concerns with regard to the use of colloidal silver in nano form in cosmetic products.

The SCCS’s scientific opinion is due six months from receipt of the EC’s request.

NIEHS-Funded Center Will Assess Safety of Engineered Nanomaterials

Posted in Federal, Research, United States

The National Institute of Environmental Health Sciences (NIEHS) is funding a new interdisciplinary Nanosafety Research Center at the T.H. Chan Harvard School of Public Health (HSPH).  The main focus of the new HSPH-NIEHS Center is to bring together scientists from across disciplines — material science, chemistry, exposure assessment, risk assessment, nanotoxicology, and nanobiology — to assess the potential environmental health and safety implications of engineered nanomaterials.  According to an August 16, 2016, news article, the Center will focus on building a fundamental understanding of why some engineered nanomaterials are potentially more harmful than others.  The Center will also establish a “reference library” of engineered nanomaterials, each with slightly varied properties, which will be used in nanotoxicology research to assess safety.  This will allow researchers to pinpoint exactly what aspect of an engineered nanomaterials’ properties may impact health.  The researchers will also work to develop standardized methods for nanotoxicology studies evaluating the safety of nanomaterials.