Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

NNI Publishes Supplement to President’s 2019 Budget Request

Posted in Federal, Research, United States

The National Nanotechnology Initiative (NNI) has published The National Nanotechnology Initiative Supplement to the President’s 2019 Budget.  The August 2018 document not only supplements the President’s budget request for fiscal year 2019, but also serves as NNI’s annual report and addresses the requirement for Department of Defense (DOD) reporting on its nanotechnology investments.  President Trump requests nearly $1.4 billion for NNI, “a continued investment in basic research, early-stage applied research, and technology transfer efforts that will lead to the breakthroughs of the future.”  According to the document, the actual NNI investments are higher for 2017 than the estimated and requested levels.  For example, the participating agencies reported $1.55 billion in actual NNI investments for 2017, “significantly larger than 2017 estimated investments previously published in the 2018 Budget ($1.47 billion) and 2017 requested investments published in the 2017 Budget ($1.44 billion).”  The President’s 2019 budget, which requests nearly $1.4 billion for NNI, supports nanoscale science, engineering, and technology research and development (R&D) at 12 agencies.  The five federal organizations with the largest investments (representing 95 percent of the total) are:

  • Department of Health and Human Services (HHS)/National Institutes of Health (nanotechnology-based biomedical research at the intersection of life and physical sciences);
  • National Science Foundation (fundamental research and education across all disciplines of science and engineering);
  • Department of Energy (fundamental and applied research providing a basis for new and improved energy technologies);
  • DOD (science and engineering research advancing defense and dual-use capabilities); and
  • Department of Commerce/National Institute of Standards and Technology (fundamental R&D of measurement and fabrication tools, analytical methodologies, metrology, and standards for nanotechnology).

The report states that other agencies and agency components investing in mission-related nanotechnology research are the Consumer Product Safety Commission; HHS/Food and Drug Administration; HHS/National Institute for Occupational Safety and Health; Department of Homeland Security; Department of Justice; Department of Transportation/Federal Highway Administration; U.S. Environmental Protection Agency; National Aeronautics and Space Administration; U.S. Department of Agriculture (USDA)/Agriculture Research Service; USDA/Forest Service; and USDA/National Institute of Food and Agriculture.  Appendix A provides an overview of nanotechnology R&D by agency.  The document also provides highlights illustrating progress toward each of the four NNI goals:

  • Goal 1. Advance a World-Class Nanotechnology R&D Program;
  • Goal 2. Foster the Transfer of New Technologies into Products for Commercial and Public Benefit;
  • Goal 3. Develop and Sustain Educational Resources, a Skilled Workforce, and a Dynamic Infrastructure and Toolset to Advance Nanotechnology; and
  • Goal 4. Support Responsible Development of Nanotechnology.

 

NNCO Will Focus on Public Outreach and Promoting Commercialization of Nanotechnology

Posted in Federal, Legal/Regulatory Issues, United States

According to the Summer 2018 edition of the National Nanotechnology Coordination Office’s (NNCO) quarterly newsletter, in 2018, NNCO will focus on two of its primary responsibilities — providing public outreach and promoting commercialization of nanotechnology.  NNCO states that its activities “will build upon and expand efforts to tell the stories” from the National Nanotechnology Initiative (NNI), and to support the nanotechnology community by facilitating networks, promoting access to resources, and sharing best practices.  For example, based on the positive feedback from the Technology Development Pathways:  Case Studies from the NNI workshop and town hall held in November 2017, NNCO plans to hold another workshop and a series of webinars using this framework.  According to NNCO, these efforts focus on sharing information intended to assist the commercialization of nanotechnologies, aimed in particular at small- and medium-sized enterprises.  NNCO states that additional efforts “will also concentrate on nanotechnology-focused entrepreneurship and the burgeoning community of interest in this area.”

EC JRC Publishes Report on Mapping Nanomedicine Terminology in Regulatory Landscape

Posted in International, Research

The European Commission’s (EC) Joint Research Center has published a Technical Report entitled Mapping Nanomedicine Terminology in the Regulatory Landscape.  According to the abstract, to support a better understanding of terms used in the regulatory domain, the Nanomedicines Working Group of the International Pharmaceutical Regulators Forum (IPRF) prioritized the need to map, compile, and discuss the currently used terminology of regulatory scientists coming from different geographic areas.  JRC took the lead to identify and compile frequently used terms in the field by using web crawling and text mining tools, as well as the manual extraction of terms.  The abstract states that the compilation and analysis of extracted terms demonstrated sectorial and geographical differences in the frequency and type of nanomedicine related terms used in a regulatory context.  JRC compiled, discussed, and analyzed the 31 relevant and most frequently used terms derived from various agencies for their similarities and differences.  The descriptions are intended to support the development of harmonized use of terminology in the future.  The report “provides necessary background information to advance the discussion among stakeholders.  It will strengthen activities aiming to develop harmonised standards in the field of nanomedicine, which is an essential factor to stimulate innovation and industrial competitiveness.”

Registration Opens for NNI Webinar on NanoEHS and Nanomedicine

Posted in Federal, Occupational Health and Safety Issues, Research, United States

Registration has opened for an August 20, 2018, webinar on “NanoEHS and Nanomedicine:  Similarities and Synergisms.”  The National Nanotechnology Initiative (NNI) notes that there are many synergies between nanomedicine research, which addresses (among other topics) issues of efficacy and safety, and studies on the environmental, health, and safety effects of nanomaterials (nanoEHS), which include the exploration of potential toxicity and exposures.  Research in these complementary fields continues to grow, and this webinar will explore ways that these disciplines can support and augment each other.  Panelists will provide a comparative overview of these two disciplines and discuss how each field’s tools and approaches have developed and how they can inform each other.  The panel will offer perspectives on the opportunities for practitioners and researchers in both areas to tackle common challenges.  Dr. Mark Hoover, Senior Research Scientist, National Institute for Occupational Safety and Health, and Dr. Christina Liu, Program Director, Nanodelivery Systems and Devices Branch, Cancer Imaging Program, National Cancer Institute, National Institutes of Health, will moderate the panel, which will include:

  • Hamid Ghandehari, Professor of Bioengineering, University of Utah;
  • Christine Payne, Associate Professor, Duke University; and
  • Monika Mortimer, Project Scientist, Bren School of Environmental Science and Management, University of California, Santa Barbara.

Webinar viewers will be able to submit questions for the panelists to answer during the question and answer period.  Submitted questions will be considered in the order received and may be posted on the NNI website.

German Environment Agency Publishes Fact Sheet on Use of Nanomaterials in Plastic Packaging

Posted in EU Member State, International

The German Environment Agency (UBA) has published an August 2018 fact sheet, in German, regarding the use of nanomaterials in plastic packaging.  The fact sheet addresses nanomaterials that promise new, technical, or improved packaging properties.  According to UBA, the nanomaterials used for labeling and surface coating of packaging are partly the same as those used in (printing) paints and varnishes.  Because most of the potential use of nanomaterials in packaging lies in the field of plastics and plastic packaging, the fact sheet focuses on the use of nanomaterials in these materials.

EFSA Panel Concludes New Titanium Dioxide Studies Do Not Merit Reopening Opinion

Posted in International, Legal/Regulatory Issues, Research

The July 2018 issue of the EFSA Journal includes an article entitled “Evaluation of four new studies on the potential toxicity of titanium dioxide used as a food additive (E 171).”  The European Commission (EC) asked the European Food Safety Authority (EFSA) to carry out a scientific evaluation on four studies on the potential toxicity of titanium dioxide used as a food additive (E 171) and to indicate whether they would merit re-opening EFSA’s 2016 opinion on the safety of titanium dioxide (E 171) as a food additive.  The article states that overall, three of the studies assessed reported that titanium dioxide was able to induce various effects in in vitro and in vivo models.  According to the EFSA Panel, these studies may be useful for hazard identification of titanium dioxide.  The article notes that the Panel considered that the limited relevance of the protocols of these studies to the use of E 171 under realistic conditions in food hampered the use of the data in the risk assessment of the food additive E 171.  In the fourth study, Heringa et al. (2016), numerous assumptions were made, which resulted in large uncertainty in their conclusion.  The article states that more research exploring the possible effects observed in three of the four studies could address their applicability to the risk assessment of the food additive E 171 under realistic conditions of use.  Altogether, the Panel concluded that the outcome of the four studies did not merit re-opening the existing opinion of EFSA related to the safety of titanium dioxide (E 171) as a food additive.

NNCO Announces Reappointment of Director and Appointment of New Deputy Director

Posted in Federal, Legal/Regulatory Issues, United States

On July 30, 2018, the National Nanotechnology Coordination Office (NNCO) announced the reappointment of Dr. Lisa Friedersdorf as its Director and the appointment of Dr. Stacey Standridge as its Deputy Director.  NNCO is a federal interagency coordinating office that serves as a central point of contact for the National Nanotechnology Initiative (NNI) and supports the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the National Science and Technology Council.  NNCO states that Dr. Friedersdorf joined NNCO in December 2011 and served as Senior Scientist and Program Manager for the Nanotechnology Signature Initiatives (NSI).  She became NNCO’s Deputy Director in May 2014 and NNCO’s Director in October 2016.  Dr. Friedersdorf has been involved in nanotechnology for more than 25 years, with a particular interest in advancing technology commercialization through university-industry-government collaboration.  According to NNCO, she is also a strong advocate for science, technology, engineering, and mathematics (STEM) education and has over two decades of experience teaching at both the university and high school levels.  NNCO states that Dr. Standridge joined NNCO in June 2011 and has been NNCO’s Acting Chief of Staff since October 2017.  In that role, Dr. Standridge actively engaged with stakeholders in support of focused, high-priority interagency nanotechnology activities (NSIs).  Dr. Standridge also has played a critical role in creating and sustaining a long-term collaboration with the European Commission and European scientists on the development of shared knowledge and best practices related to research on the safety of nanomaterials.  She will also serve as the NNI Coordinator for Global Issues.

ACGIH® Will Not Proceed with TLV® for Carbon Nanotubes in 2019

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

As reported in our January 31, 2018, blog item, the American Conference of Governmental Industrial Hygienists (ACGIH®) Threshold Limit Values for Chemical Substances (TLV®-CS) Committee included carbon nanotubes on its 2018 list of chemical substances and other issues under study.  Being placed on the under study list indicated that the TLV®-CS Committee had selected carbon nanotubes for development of a threshold limit value (TLV®).  On July 26, 2018, ACGIH® announced the release of its two-tier under study list.  Tier 1 lists the chemical substances and physical agents that may move forward as a notice of intended change (NIC) or notice of intent to establish (NIE) in the upcoming year, based on their status in the development process.  Tier 2 consists of those chemical substances and physical agents that will not move forward, but will either remain on or be removed from the under study list for the next year.  Carbon nanotubes are included in Tier 2.  If carbon nanotubes are included on the 2019 under study list, stakeholders will have an opportunity to submit substantive data and comments.

NIOSH Draft CIB on Occupational Risk Assessment Discusses Emerging Practices, Including Nanomaterials Risk Assessment

Posted in Federal, Occupational Health and Safety Issues, United States

On July 26, 2018, the National Institute for Occupational Safety and Health (NIOSH) announced the availability of a draft Current Intelligence Bulletin:  NIOSH Practices in Occupational Risk Assessment.  The draft Current Intelligence Bulletin (CIB) describes the underlying science and general approach used by NIOSH researchers when conducting high quality, scientifically sound assessments of the health risk associated with workplace hazards.  The draft CIB focuses on chemical risk assessment practices.  The information provided by the draft CIB is intended for NIOSH risk assessors, other scientists, stakeholders, and the public to improve their understanding of the NIOSH risk assessment process.  NIOSH states that the purpose of the public review is to obtain comments on whether the draft CIB:  (1) adequately, clearly, and concisely explains NIOSH practices in risk assessment; and (2) demonstrates that its practices are consistent with the current scientific knowledge.  Appendix C addresses emerging practices and includes a section on nanomaterials risk assessment.  The draft CIB states:  “Given the large and growing number of engineered nanomaterials (ENMs) with limited data, as for other emerging and existing substances produced or used in the workplace, alternative test strategies (i.e., a toxicological approach other than primary animal testing), such as high throughput screening and in vitro exposures, may help to fill the gaps by providing data that could be used in validated hazard and risk assessment models.”  According to the draft CIB, a “promising use of alternative test strategies data is comparative potency analyses between nanomaterials and benchmark materials” for use in the development of occupational exposure bands.  The draft CIB states that possible benchmark materials to evaluate inhalation hazards “may include fine crystalline silica, asbestos, and ultrafine titanium dioxide and/or carbon black.”

NIOSH will hold an online meeting on September 13, 2018, from 1 p.m. – 4 p.m. (ET).  The public online meeting will be a web-based event available only by remote access.  NIOSH states that special emphasis will be placed on discussion of the following questions for reviewers:

(1)  Are the methods presented in the draft CIB consistent with the current scientific knowledge of toxicology, epidemiology, industrial hygiene, and risk assessment;

(2)  Is there additional scientific information related to the issues of the draft CIB that should be considered for inclusion or any discussion that should be omitted; and

(3)  Is information explained in a clear and transparent manner.

Written comments must be submitted to the docket by October 15, 2018.

Helsinki Chemicals Forum Includes Debate on Nanomaterials

Posted in International, Legal/Regulatory Issues

The tenth Helsinki Chemicals Forum was held on June 14-15, 2018, in Helsinki, Finland.  According to the Conference Report, prepared by Chemical Watch, 168 delegates from 37 countries attended.  The final debate at the Forum used nanomaterials as a case study to argue whether product stewardship can replace regulation.  Roger Drew, ToxConsult, moderated the debate between David Azoulay, Center for International Environmental Law (CIEL) and David Warheit, Ph.D., The Chemours Company.  The Conference Report lists a number of open questions, and provides the following “bottom line” bullet points:

  • While regulation and product stewardship both play a part, the latter is not necessarily sufficient to guarantee the safety of the material;
  • The role of product stewardship is not always clear and must be better defined and communicated;
  • One weakness of product stewardship is that companies do not sufficiently communicate what they do;
  • Instead of stating or suggesting that everything on the market is safe, industry and regulators should be forthcoming about the complexity of the issue and acknowledge that there are still some unknowns; and
  • “There is no such thing as a safe nanomaterial — only safe ways of using nanomaterials. Some knowledge of nanomaterial hazards as directed by regulations is needed.”  Responsible and safe manufacture and use of nanomaterials is possible, however, even in the presence of uncertainty and without complete hazard knowledge.

The Conference Report is “not a formal report,” but rather “aims to be a balanced and accessible reflection of two days of debate as a means to further understanding.”  It provides an “unedited selection of comments and questions raised on the message wall,” including a number of comments regarding the debate.