Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

EC Publishes Inception Impact Assessment Concerning Possible REACH Annex Amendments for Registration of Nanomaterials

Posted in International, Legal/Regulatory Issues

On February 2, 2016, the European Commission (EC) published an inception impact assessment concerning “Possible amendments of Annexes to REACH for registration of nanomaterials.”  According to the inception impact assessment, the EC identified a need for more specific requirements for nanomaterials to ensure further clarity on how nanomaterials are addressed and safety demonstrated in registration dossiers to attain the aims of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  This initiative intends to solve how nanomaterials should be addressed and safety demonstrated in REACH registration dossiers.  The inception impact assessment identifies the following options:

  • Baseline scenario — no European Union (EU) policy change;
    • Option 1: No change;
  • Options of improving implementation and enforcement of existing legislation or doing less/simplifying existing legislation:
    • Option 2: Clarifying the existing information requirements;
    • Option 3: Soft law measures;
    • Option 4: Scientific-technical recommendations tailoring information requirements;
    • Option 5: Reduced information requirements; and
    • Option 6: Exhaustive information requirements.

The chosen option, if different to the baseline scenario, will take the form of a draft EC implementing regulation amending certain REACH Annexes, and the EC will submit it to the REACH Committee for opinion in accordance with REACH Article 133(4) before its adoption by the EC.  The inception impact assessment states that work on the impact assessment was expected to conclude by the end of 2015.

OSTP Seeks Nanotechnology Commercialization Success Stories

Posted in Federal, United States

On February 2, 2016, the Office of Science and Technology Policy (OSTP) published in the Federal Register a request for information (RFI) seeking examples of commercialization success stories stemming from U.S. government-funded nanotechnology research and development (R&D) since the inception of the National Nanotechnology Initiative (NNI) in 2001.  OSTP states that the information gathered in response to this RFI may be used as examples to highlight the NNI’s impact or to inform future activities to promote the commercialization of federally funded nanotechnology R&D.  Depending on the nature of the feedback, OSTP may use responses to shape the agenda for a workshop to share best practices and showcase commercial nanotechnology-enabled products and services.  OSTP also posted a blog item regarding the RFI, which describes “pioneering nanotechnology research by two 2015 National Medal of Science and one National Medal of Technology and Innovation recipients [that] has found its way into multiple commercial products.”  OSTP invites responses from commercial entities, academic institutions, government laboratories, and individuals who have participated in federally funded R&D; collaborated with federal laboratories; used federally funded user facilities for nanoscale fabrication, characterization, and/or simulation; or have otherwise benefited from NNI agency resources.  Responses are due February 29, 2016.

OECD Publishes Reports Concerning Nanomaterials

Posted in International, Legal/Regulatory Issues, OECD, Research

The Organization for Economic Cooperation and Development (OECD) has posted the following reports concerning nanomaterials:

  • Considerations for Using Dissolution as a Function of Surface Chemistry to Evaluate Environmental Behaviour Of Nanomaterials in Risk Assessments:  A Preliminary Case Study Using Silver Nanoparticles — The December 18, 2015, report discusses preliminary findings on dissolution by media type, provides recommendations, compares silver nanoparticles to other nanomaterials, and summarizes additional needs.
  • Physical-Chemical Parameters:  Measurements and Methods Relevant for the Regulation of Nanomaterials — The January 21, 2016, OECD workshop report summarizes the June 18-19, 2014, OECD Working Party on Manufactured Nanomaterials (WPMN) meeting on Nanomaterials Physical-Chemical Parameters.  The main objectives of the meeting were to identify the appropriate test methods for physical-chemical parameters for manufactured nanomaterials, building on the experience from the OECD Testing Program, the knowledge acquired through the research done by physical-chemical and metrology experts, and if possible, to determine which test methods are appropriate for both a particular parameter and particular types of nanomaterials.  The report includes the following recommendations:  a decision tree needs to be developed for particle size; technical guidance is needed on the application of electron microscopy for determining the size and size distribution and shape of particulate materials; and guidance needs to be developed in tandem to the decision tree on dispersion protocols, while considering defining smallest dispersible size.  For all the physical-chemical properties discussed, the group saw the need to identify the appropriateness of techniques/methodologies for specific measurands for different nanomaterial chemical/structural-based categories; to develop a guidance document based on the chemical identification descriptors/behaviors needed leading to selection of techniques/methodologies; to develop guidance on available methods for chemical composition, giving consideration to functional tests when appropriate; and to develop guidance on how to determine crystallinity, where results for the bulk are not sufficient, focusing on which methods to use when, including how to deal with surface crystallinity.
  • Approaches on Nano Grouping/Equivalence/Read-Across Concepts Based on Physical-Chemical Properties (GERA-PC) for Regulatory Regimes — The January 22, 2016, document presents responses to, and findings from, a 2013 questionnaire survey on approaches to develop or use concepts of grouping, equivalence, and read-across based on physical-chemical properties (GERA-PC) of nanomaterials for their human health and ecosystem hazard assessment in regulatory regimes.  The survey was proposed following the results of the WPMN work on risk assessment approaches to strengthen and enhance regulatory risk assessment capacity.  Thirteen responses were received from eight OECD member countries (Australia, Canada, Denmark, Germany, Japan, Switzerland, the United Kingdom, and the U.S.), one regional organization (the European Union), and one OECD partner (the Business and Industry Advisory Committee to the OECD (BIAC)).

OSTP Posts Blog Item on Educating and Inspiring Students through Nanotechnology

Posted in Federal, United States

The Office of Science and Technology Policy (OSTP) posted a blog item on January 25, 2016, on “Educating and Inspiring Students through Nanotechnology.”  The blog item states that to reap the benefits of nanotechnology, “we must train our Nation’s students for these high-tech jobs of the future.”  The blog item announces that a new six-part video series, “Nanotechnology:  Super Small Science,” shows how to educate and inspire students though nanotechnology.  The blog lists the other following examples of the National Nanotechnology Initiative’s (NNI) efforts “to educate and inspire our Nation’s students”:

  • The Generation Nano: Small Science, Superheroes contest, hosted by the National Science Foundation (NSF) and NNI, challenges high school students to design nanotechnology-enabled gear for an original superhero.  Submissions are due February 2, 2016.
  • The National Nanotechnology Coordination Office (NNCO) and the National Institute of Standards and Technology collaborated with Fairfax County Public Schools in Virginia to develop the middle school video series Innovation Workshop: Nanotechnology, which was recently distributed nationwide. Students at Western Carolina University, with guidance from the NNCO, have created educational animations about nanotechnology that are featured on Science Matters, Community Idea Stations. These videos and animations are also available through nano.gov.
  • NNCO is expanding the teacher resources on nano.gov and working with nanoHUB to develop a searchable database for nanoeducation. The blog notes that this portal “addresses a critical challenge identified at the NSF Nanoscale Science and Engineering Education (NSEE) Workshop:  the difficulty educators face in finding appropriate lesson plans, laboratories, and other resources for teaching nanoscience and engineering in their classrooms.”
  • NNCO is coordinating a growing, national Nano & Emerging Technologies Student Network. The network consists of student-run clubs at colleges and that are focused on raising awareness of current and potential applications of emerging technologies, as well as promoting opportunities for student research and internships.  The network will convene for the first time in summer 2016 at the TechConnect World Innovation Conference and Expo at the National Harbor in Maryland.

EFSA Publishes Nano Network 2015 Annual Report

Posted in International, Legal/Regulatory Issues, Research

The European Food Safety Authority (EFSA) published on January 11, 2016, the Scientific Network for Risk Assessment of Nanotechnologies in Food and Feed (Nano Network) annual report for 2015.  The report states that, during 2015, the Nano Network followed-up on its four priority topics:  (1) the need for an inventory of nanomaterials in products on the market; (2) the analysis and monitoring of products under development and on the market; (3) the need for suitable measuring methods, e.g., for physico-chemical properties; and (4) the need for validated test methods in vitro and in vivo.  Topics recommended for the 2016 program include:

  • Discussing implementation of the novel food regulation;
  • Making more materials available for research through cooperation from industries and/or through reference material development while expanding the Joint Research Center’s (JRC) repository;
  • Discussing the idea of pooling ongoing safety research to extract the data in a harmonized way; and
  • Receiving an update on the implementation of the risk assessment approach as applied by the Netherlands, and debating its wider application.

Danish EPA Assesses Administrative Burdens of Nano Product Register

Posted in International, Legal/Regulatory Issues

On January 12, 2016, the Danish Environmental Protection Agency (Danish EPA) posted a report entitled Assessment of the administrative burdens on businesses with a reporting obligation to the Danish Nanoproductregister.  Danish EPA estimated the administrative burden of businesses reporting to the Danish nano product register using the standard cost method.  According to Danish EPA, interviews with companies and industry associations contributed to estimates for the measurement of administrative burdens, and provided input to the evaluation of corporate barriers experienced by the first submitters to the register.  Danish EPA states that the interviews also contributed “to the experience and learning inputs relative to improvement opportunities and other models for mapping and provision of knowledge about nanomaterials in products.”

NIOSH Publishes Draft CIB on Health Effects of Occupational Exposure to Silver Nanomaterials, Will Hold Public Meeting

Posted in Federal, Legal/Regulatory Issues, Occupational Health and Safety Issues, United States

On January 21, 2016, the National Institute for Occupational Safety and Health (NIOSH) announced the availability of a draft NIOSH Current Intelligence Bulletin:  Health Effects of Occupational Exposure to Silver Nanomaterials.  The draft Current Intelligence Bulletin (CIB) includes a review and assessment of the currently available scientific literature on the toxicological effects of exposure to silver nanoparticles in experimental animal and cellular systems, and on the occupational exposures to silver dust and fume and the associated health effects.  According to the draft CIB, “[a]lthough the experimental animal and cellular studies are useful for showing potential risks from exposure to silver nanomaterials, NIOSH considers the currently available data to be too limited to develop a REL for silver that is specific to particle size.” Instead, NIOSH recommends that effective risk management control practices be implemented so that worker exposures to silver nanomaterials do not exceed the NIOSH recommended exposure limit (REL) of ten micrograms per cubic meter (μg/m3) (eight-hour time-weighted average) for silver metal dust, fume, and soluble compounds, measured as a total airborne mass concentration.  NIOSH “recommends additional prudent measures including conducting workplace exposure and hazard assessments and medical surveillance of workers potentially exposed to silver nanomaterials.”  The draft CIB provides recommendations for the safe handling of silver nanoparticles, and proposes research needs to fill important data gaps in the current scientific literature on the potential adverse health effects of occupational exposure to silver nanoparticles.  NIOSH seeks public comments on the draft CIB, and will hold a public meeting to discuss the CIB on March 23, 2016.  Comments are due March 21, 2016.

The Federal Register notice states that special emphasis will be placed on discussion of the following:

  • Whether the health hazard identification, risk estimation, and discussion of health effects of silver and silver nanomaterials are a reasonable reflection of the current understanding of the scientific literature;
  • Workplaces and occupations where exposure to silver and silver nanomaterials may occur; and studies on health effects associated with occupational exposure to silver dust and fume;
  • Current strategies for controlling or preventing exposure to silver and silver nanomaterials (g., engineering controls, work practices, personal protective equipment);
  • Current exposure measurement methods and challenges in measuring workplace exposures to silver nanomaterials; and
  • Areas for future collaborative efforts (g., research, communication, development of exposure measurement and control strategies).

During the public meeting, NIOSH will allow commenters to provide oral comments on the draft CIB, to inform NIOSH about additional relevant data or information, and to ask questions on the draft CIB and NIOSH recommendations.  The Federal Register notice states that the forum will include scientists and representatives from various government agencies, industry, labor, and other stakeholders, and is open to the public.  The meeting will be open to a limited number of participants through a conference call phone number and will be webcast live on the Internet.  Due to the limited spaces, notification of intent to attend the meeting must be made no later than March 9, 2016.  NIOSH states that it will give priority for attendance to those providing oral comments.  Other requests to attend the meeting will then be accommodated on a first-come, first-served basis.

Society for the Study of New and Emerging Technologies Launches New Website and Twitter Account, Will Hold Annual Meeting in October

Posted in Uncategorized

The Society for the Study of New and Emerging Technologies (S.NET), an international association promoting intellectual exchange and critical inquiry about the advancement of new and emerging technologies in society, has launched a new website and twitter account. S.NET represents diverse communities, disciplines, viewpoints, and methodologies in the social sciences and humanities. It also welcomes contributions from scientists and engineers that advance the critical reflection of nanoscience and other emerging technologies. Its eighth annual meeting, “The Co-Production of Emerging Bodies, Politics and Technologies,” will be held October 12-14, 2016, in Bergen, Norway. The meeting will examine questions such as how emerging technologies such as nanotechnology or synthetic biology shape institutions, citizen organizations, and other political agencies, and how these emerging technologies are shaped by politics. The conference organizers invite proposals for papers, panels, film viewings, art exhibits, installations, and other creative formats.

Proceedings Available on 2015 U.S.-EU Joint Workshop on Bridging NanoEHS Research Efforts

Posted in Federal, International, Research, United States

In December 2015, the proceedings from the March 12-13, 2015, U.S.-European Union (EU) joint workshop on “Bridging NanoEHS Research Efforts” were posted online.  The workshop was sponsored by the European Commission (EC) and the National Nanotechnology Initiative (NNI).  It brought together European and American scientists engaged in nanotechnology environmental, health, and safety (nanoEHS) research to identify areas of shared nanoEHS interest and mechanisms for collaboration to advance the science.  The report includes information on the following:

  • NanoEHS Scrimmage:
    • Purpose and Goals;
    • Scrimmage Steps;
    • Results of the nanoEHS Scrimmage; and
    • Discussion of the Results and Recommendations.
  • Community of Research (COR) Breakout Sessions and Plenary Reports:
    • EcoToxicity COR;
    • Human Toxicity COR;
    • Databases and Computational Modelling for nanoEHS COR;
    • Exposure through Product Life COR;
    • Risk Assessment COR;
    • Risk Management and Control COR; and
    • Characterization COR.
  • Research Strategies:
    • Quality Assurance for the Characterization of Nanomaterials and Implementation of Labelling Requirements for Food and Consumer Products;
    • S. Progress Review on the Coordinated Implementation of the NNI 2011 EHS Research Strategy;
    • Research Needs and Data Gaps;
    • Regulatory Research Roadmap; and
    • EU Closer to the Market Roadmap.
  • Collaborations and Funding Opportunities —
    • S. Funding Opportunities;
    • NANoREG Progress Report, ProSafe, and NANoREG II; and
    • EU Funding Opportunities.

The Netherlands Publishes Report on Nanotechnologies in Medical Devices

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

The Netherlands National Institute for Public Health and the Environment (RIVM) posted on December 17, 2015, a report entitled Nanotechnologies in medical devices.  RIVM conducted an investigation to provide insights into and an overview of the field of medical devices using nanotechnologies for products already on the market and for those expected within five years.  According to the report, knowledge is evolving on the safety evaluation of nanomaterials in general, and thus also when used in medical devices.  The report states that current state-of-the-art guidance provides a “suitable base” for assessing the risk of nanomedical devices.  The report states:  “Nanomaterials exhibit specific characteristics that may or may not lead to toxic effects.  As for all medical products, risk assessment of nanomedical products needs to be performed on a case-by-case basis.  The potential for release, leading to a higher or lower exposure to nanomaterials, is considered the most important feature driving the extent of the risk assessment to be performed.”