NNCO Will Hold Webinar on 2011 EHS Research Strategy Progress Review

On July 31, 2014, the National Nanotechnology Coordination Office (NNCO) will hold a public webinar to provide a forum to answer questions related to the federal government’s “Progress Review on the Coordinated Implementation of the National Nanotechnology Initiative 2011 Environmental, Health, and Safety Research Strategy.” According to the July 22, 2014, Federal Register notice, discussion will focus on the research activities undertaken by the National Nanotechnology Initiative (NNI) agencies to advance the current state of the science as highlighted in the Progress Review. Representative research activities as provided in the Progress Review will be discussed in the context of the 2011 NNI Environmental, Health, and Safety (EHS) Research Strategy’s six core research areas: nanomaterial measurement infrastructure; human exposure assessment; human health; the environment; risk assessment and risk management methods; and informatics and modeling. Questions on the Progress Review document may be submitted beginning July 24, 2014, through the close of the webinar. During the question-and-answer segment of the webinar, submitted questions will be considered in the order received.

EC and SCENIHR Begin Public Consultation on Preliminary Opinion on Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices

The European Commission (EC) and the Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) have begun a public consultation on the preliminary opinion concerning “Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices.” The aim of the opinion is to address the use of nanomaterials in medical devices and to provide information for risk assessors regarding specific aspects that need to be considered in the safety evaluation of nanomaterials. Guidance is provided on physico-chemical characterization of nanomaterials, the determination of hazards associated with the use of nanomaterials, and risk assessment for the use of nanomaterials in medical devices.  The safety evaluation of nanomaterials used in medical devices is discussed in the context of the general framework for biological evaluation of medical devices as described in the International Organization for Standardization (ISO) 10993-30 1:2009 standard.  Therefore, the risk assessment is performed taking into consideration type of device, type of tissue contact, and the duration of contact, thus identifying the specific exposure scenario.  The Guidance is intended to provide information to help with safety evaluation and risk assessment of the use of nanomaterials in medical devices that should be considered in conjunction with the ISO 10993-1:2009 standard.  The Guidance highlights the need for special considerations in relation to the safety evaluation of nanomaterials in view of the possible distinct properties, interactions, and/or effects that may differ from conventional forms of the same materials.  For the risk evaluation of the use of nanomaterials in medical devices, a phased approach is recommended based on potential release and characteristics of the nanomaterials. SCENIHR is seeking comments on the risk assessment related to the Guidance. Comments are due October 3, 2014.

Registration Open for SRA Nano Risk Analysis (II) Workshop

Registration is now open for Nano Risk Analysis (II), a workshop to explore how a multiple models approach can advance risk analysis of nanoscale materials. The workshop, which is being organized by the Emerging Nanoscale Materials Specialty Group (ENMSG) of the Society for Risk Analysis (SRA) and co-sponsored by Bergeson & Campbell, P.C., will be held September 15-16, 2014, in Washington, D.C. The workshop will bring together experts from diverse disciplines to explore ways that Alternative Testing Strategies (ATS) may be combined to create a Weight of Evidence (WOE) or “multiple models” approach to inform context -- specific decisions about risk from exposure to novel nanoscale materials.  The goal is to advance a common understanding of the state of the science, early lessons, current opportunities, and next steps for developing ATS for use in decision making for nanoscale materials. The output of the workshop will be a set of recommendations reported to the Organization for Economic Cooperation and Development (OECD) Working Party on Manufactured Nanomaterials (WPMN) and via peer reviewed publications and web-based portals about ways in which these approaches may be practically applied in the near term to improve environmental decision making by governmental and industrial organizations. Abstracts for posters to be presented at the workshop are due August 1, 2014.

OECD Publishes Report of Expert Meeting on Physical Chemical Properties of Manufactured Nanomaterials and Test Guidelines

On July 15, 2014, the Organization for Economic Cooperation and Development (OECD) posted the July 2014 Report of the OECD Expert Meeting on the Physical Chemical Properties of Manufactured Nanomaterials and Test Guidelines. The Report presents the discussion and recommendations from the February 28-March 1, 2013, workshop on “Physico-chemical Properties of Manufactured Nanomaterials and Test Guidelines.” OECD notes that the workshop was organized “in close collaboration with the International Organization for Standardization Technical Committee on Nanotechnologies (ISO/TC 229),” which “provided an important dimension for the analysis of the physical-chemical properties of manufactured nanomaterials.” The discussion focused on selected endpoints and those existing OECD Test Guidelines and other methods and protocols that are being used to address them. The categories of endpoints selected included:

  1. State of Dispersion, Aggregation and Agglomeration of Nanomaterials;
  2. Size (and Size Distribution) of Nanoparticles;
  3. Surface Area and Porosity; and
  4. Surface Reactivity.

Four breakout groups were formed with the task to address the following questions:

  • Identify the relevance of these endpoints as additions to conventional physical-chemical characterization; and if relevant, outline possible methods (i.e., new OECD Test Guidelines) based on the outcomes of the OECD Testing Program and other sources of information;
  • Identify whether there is a need for specific guidance documents for testing and assessment of the physical-chemical properties of nanomaterials or adaptation of existing OECD Guidance Documents;
  • Discuss whether specific sections should be developed for the “Guidance on Sample Preparation and Dosimetry” (GSPD) on the basis of the experiences obtained in the Testing Program and other new developments in the area of testing and assessment of physical-chemical properties; and
  • Identify whether specific endpoints and/or OECD Test Guidelines are relevant to different categories of nanomaterials.
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EC Posts Meeting Materials from Validation Workshop on Transparency Measures for Nanomaterials

The European Commission (EC) has posted materials from its June 30, 2014, validation workshop to discuss the preliminary results of the study supporting the impact assessment on transparency measures for nanomaterials. The EC is conducting a study to evaluate existing notification systems for nanomaterials and to collect data in support of the assessment of different policy options.  The EC discussed the preliminary results with stakeholders at the validation workshop and invited their input on the study and the related impact assessment. The validation workshop materials include:

  • Agenda;
  • Introduction to the European Union (EU) legislative framework for nanomaterials and the study on transparency measures for nanomaterials;
  • Evaluation of existing nanomaterial notification systems;
  • Hazards and risks of nanomaterials and potential benefits of transparency measures;
  • Nanomaterials markets (value chain characterization, growth, and innovation) and potential impacts of the transparency measures; and
  • Outlook to the assessment of policy options.

Canada Endorses OECD Recommendation on Nanomaterials

The Summer 2014 issue of Canada’s Chemicals Management Plan Progress Report includes an item concerning nanomaterials. According to the article entitled “Canada Working on Nanomaterials at Home and Abroad,” Canada has endorsed a recommendation from the Organization for Economic Cooperation and Development (OECD) that its Member Countries apply existing regulatory frameworks to manage risks associated with manufactured nanomaterials. The article also states that the Canada-U.S. Regulatory Cooperation Council (RCC) Nanotechnology Initiative is complete and that the final reports will be published this summer.  According to the article, the reports will include recommendations on how Canada and the U.S. can align their nanomaterial regulatory work, including the application of consistent risk assessment approaches and methodologies and identifying categories of nanomaterials.

EPA Promulgates SNURs for Two CNT Substances

On July 8, 2014, the U.S. Environmental Protection Agency (EPA) promulgated significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that were the subject of premanufacture notices (PMN). The rule includes two PMN substances, P-10-5 and P-11-339, that were the subject of TSCA Section 5(e) consent orders and whose reported chemical names include the term “carbon nanotube” (CNT) or “CNT.” EPA states that, because of a lack of established nomenclature for CNTs, the TSCA Inventory names for CNTs are currently in generic form, e.g., CNT, multi-walled carbon nanotube (MWCNT), double-walled carbon nanotube (DWCNT), or single-walled carbon nanotube (SWCNT).

PMN Number P-10-5

Chemical Name:  Single-walled carbon nanotubes (generic)

CAS Number:  Claimed confidential

The PMN states that the uses of the substance will be as a component for a conductive coating using the PMN substance in a dispersion or ink, and as an additive in resins/thermoplastics/elastomers for mechanical reinforcement.  The consent order requires:

  1. Use of personal protective equipment (PPE);
  2. Use of the substance only as a component for a conductive coating using the PMN substance in a dispersion or ink or as an additive in resins/thermoplastics/elastomers for mechanical reinforcement;
  3. Manufacture of the substance at a volume not to exceed a confidential volume specified in the consent order unless the company has submitted the results of certain health studies and physical/chemical properties data; and
  4. No surface water releases of the PMN substance, except for limited water releases resulting in no more than one part per billion (ppb) waste water effluent concentration determined by monitoring.  The company shall analyze the concentration of the PMN substance in waste water discharged to the city sewer from the facility every year and adhere to the monitoring procedure referenced in the consent order.

The SNUR designates as a “significant new use” the absence of these protective measures.

PMN Number P-11-339

Chemical Name:  Multi-walled carbon nanotubes (generic)

CAS Number:  Claimed confidential

The PMN states that the use of the substance will be as an additive in resins, thermoplastics, and elastomers for mechanical reinforcement and enhanced electrical performance, as a coating on metallic foils for battery applications, or in the manufacture of fabric composites.  The consent order requires:

  1. Use of PPE;
  2. Use of the substance only as an additive in resins, thermoplastics, and elastomers for mechanical reinforcement and enhanced electrical performance, as a coating on metallic foils for battery applications, or in the manufacture of fabric composites;
  3. Manufacture of the substance at a volume not to exceed a confidential volume specified in the consent order unless the company has submitted the results of certain health studies and physical/chemical properties data; and
  4. No surface water releases of the PMN substance, except for limited water releases resulting in no more than one ppb waste water effluent concentration determined by monitoring.  The company shall analyze the concentration of the PMN substance in waste water discharged to the city sewer from the facility every year and adhere to the monitoring procedure referenced in the consent order.

The SNUR designates as a “significant new use” the absence of these protective measures.

The SNURs are effective on September 8, 2014. Written adverse or critical comments or notice of intent to submit adverse or critical comments, on one or more of these SNURs is due August 7, 2014. If EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs, EPA will withdraw the relevant sections of the direct final rule before its effective date.

Silver Nanotechnology Working Group Welcomes New Members

The Silver Nanotechnology Working Group (SNWG) was founded in 2009 as an industry-wide effort to advance the science and public understanding of the beneficial uses of silver nanoparticles in a wide-range of consumer and industrial products. It does this by fostering the collection of environmental, occupational and health, and consumer product data on silver nanotechnology. Since its founding, the focus of the SNWG has been to encourage the U.S. Environmental Protection Agency (EPA) and other global regulators towards a clear, responsible, and reasonable regulatory path for nanoscale silver additives in a wide variety of products. The SNWG with the help of its members, consultants, and the Silver Institute will continue to do everything possible to reach this goal as soon as possible. Membership in the SNWG is open to any entity with nanosilver interests that wishes to be updated frequently on nanosilver policy issues and be involved with influencing nanosilver regulatory policy. More information is available on the SNWG website and by contacting Rosalind Volpe, D.PH for membership details.

EC Posts Draft Reports for Impact Assessment on Transparency Measures for Nanomaterials

On June 30, 2014, the European Commission (EC) held a validation workshop to discuss the preliminary results of the study supporting the impact assessment on transparency measures for nanomaterials. As part of the workshop, the EC released the following reports:

The EC released a working document in May 2014 as part of its public consultation on transparency measures for nanomaterials in the market, which will end on August 5, 2014.

NNI Publishes Progress Review of 2011 EHS Research Strategy

On June 25, 2014, the National Nanotechnology Initiative (NNI) posted Progress Review on the Coordinated Implementation of the National Nanotechnology Initiative 2011 Environmental, Health, and Safety Research Strategy, which provides an overview of progress on the implementation and coordination of the 2011 NNI Environmental, Health, and Safety (EHS) Research Strategy that was developed by the Nanoscale Science, Engineering, and Technology Subcommittee’s Nanotechnology Environmental and Health Implications (NEHI) Working Group. According to the NNI, consistent with the adaptive management process described in the Research Strategy, “the NEHI Working Group has made significant progress through the use of various evaluation tools to understand the current status of nanotechnology-related EHS (nanoEHS) research and the Federal nanoEHS research investment.” NNI states: “Most notably, the participating agencies reported to the NEHI Working Group examples of ongoing, completed, and anticipated EHS research (from FY 2009 through FY 2012) relevant to implementation of the 2011 NNI EHS Research Strategy.” Overall, according to NNI, coordination and implementation of the 2011 NNI EHS Strategy across the NEHI agencies has enabled:

  • Development of comprehensive measurement tools that consider the full life cycles of engineered nanomaterials (ENM) in various media;
  • Collection of exposure assessment data and resources to inform workplace exposure control strategies for key classes of ENMs;
  • Enhanced understanding of the modes of interaction between ENMs and physiological systems relevant to human biology;
  • Improved assessment of transport and transformations of ENMs in various environmental media, biological systems, and over full life cycles;
  • Development of principles for establishing robust risk assessment and risk management practices for ENMs and nanotechnology-enabled products that incorporate ENMs, as well as approaches for identifying, characterizing, and communicating risks to all stakeholders; and
  • Coordination of efforts to enhance data quality, modeling, and simulation capabilities for nanotechnology, towards building a collaborative nanoinformatics infrastructure.