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 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.
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.
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.
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.
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.
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.
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.
The July 19, 2018, issue of the European Commission’s (EC) Health-EU Newsletter includes an editorial entitled “The only concern to have about sunscreen is … did you remember to put it on?” written by Qasim Chaudhry, Chair of the Scientific Committee on Consumer Safety (SCCS) and Ulrike Bernauer, Chair of the SCCS Working Group on Nanomaterials in Cosmetic Products. According to the editorial, nanomaterials as cosmetic ingredients serve various functions, including as ultraviolet (UV)-filters (such as titanium dioxide or zinc oxide), as pigments (e.g., carbon black), or as an antimicrobial agent. SCCS published an opinion in 2013 stating that the use of nano-titanium dioxide up to a concentration of 25 percent as a UV-filter in dermally applied sunscreen products was safe to use on healthy, intact, or sunburned skin (SCCS/1516/13). The editorial notes that when a nanomaterial surface is modified with other ingredients, however, it can lead to a change in the material characteristics and as a result numerous variants of a nanomaterial may be formed. In the case of nano-titanium dioxide used in sunscreens, SCCS concluded that such variants resulting from surface modification can also be considered safe. SCCS recently published another opinion (SCCS/1580/16) that assesses whether nano-titanium dioxide coated with other materials could be considered safe for the use as a UV-filter in dermally-applied cosmetic products. SCCS concluded that the use of titanium dioxide nanomaterials coated with specified amounts of three other coating materials could also be considered safe for use in cosmetic products intended for application on healthy, intact, or sunburned skin. The editorial states that this conclusion “is mainly based on dermal penetration studies that showed that these nanomaterials did not permeate the skin and enter the body.” According to the editorial, SCCS keeps opinions “under constant review as new scientific evidence becomes available.” SCCS “is currently revising, in fact, the Guidance on the Safety Assessment of Nanomaterials in cosmetics (SCCS/1484/12) to take account of the scientific progress in the field of nanotechnology and new available testing methods.” The editorial concludes that consumers can “rest assured” that any nanomaterials in cosmetics in Europe have already gone through “the most stringent safety assessment in the world.”
On July 17, 2018, the European Union (EU) Observatory for Nanomaterials (EUON) announced the availability of a study that it commissioned, Critical review of the relevance and reliability of data sources, methods, parameters and determining factors to produce market studies on manufactured nanomaterials on the EU market. The study presents the results of a critical review of the relevance and reliability of data sources, methods, parameters, and determining factors to produce market studies on manufactured nanomaterials on the EU market. According to EUON, based on a review of a number of existing market studies and further data sources, the study identified a set of basic parameters for producing reliable market studies on nanomaterials. The study also determined additional parameters for comprehensive studies that take into account more variables and interactions. EUON states that the parameters identified as providing a reliable basis for future market studies include:
- Market analysis by segmentation, such as by geographical region, application, end use, or nanomaterial type;
- Market forecasts and compound annual growth rate;
- Market share by region, country, or company;
- Market trends, such as consumption and demand; and
- Competitive scenarios and product portfolios of key vendors.
The researchers searched for data sources from 2011 to the present using publicly available online search tools, as well as the websites of relevant public authorities such as the European Chemicals Agency (ECHA), the European Commission (EC), and EU Member States. The report provides a list of the most relevant market studies and data sources. Researchers did not consider market studies conducted before 2011, as they preceded the EC’s recommendation on the definition of nanomaterials and their scope may not correspond to the current EU definition of a nanomaterial.