Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

NIOSH Publishes PPOP on Nanotechnology Research Center

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

On June 15, 2016, the National Institute for Occupational Safety and Health (NIOSH) posted a number of Program Performance One-Pagers (PPOP), including a May 2016 PPOP on the NIOSH Nanotechnology Research Center (NTRC).  The PPOP states that the NTRC focuses on increasing understanding of hazards and related health risks to workers who make and use nanomaterials and preventing occupational exposures to nanomaterials.  The PPOP includes the following future NIOSH actions:

  • Analyze biomarkers from research studies of nanomaterial workers;
  • Publish the first in a series of nanomaterial handling guidance, “Workplace Design Solutions: Protecting Workers during the Handling/Weighing of Nanomaterials”;
  • Use data on high volume nanomaterials to characterize the size and location of the nanomaterial workforce; and
  • Complete the draft “Current Intelligence Bulletin: Approaches to Developing Occupational Exposure Limits or Bands for Engineered Nanomaterials.”

NIOSH Explores Workplace Exposure to Multi-Walled Carbon Nanotubes

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

The May 2016 issue of NIOSH Research Rounds includes an item entitled “Research Explores Workplace Exposure to Carbon Nanotubes.”  The National Institute for Occupational Safety and Health (NIOSH) summarizes the following two published papers by NIOSH investigators with partners at Kazan State Medical University, in Kazan, Russia, that explore whether workplace exposure to multi-walled carbon nanotubes could pose a risk for lung disease.  For both studies, participants from the same facility in Kazan volunteered to participate.

  • Integrated Analysis of Dysregulated ncRNA and mRNA Expression Profiles in Humans Exposed to Carbon Nanotubes: NIOSH states that workers exposed to multi-walled carbon nanotubes were significantly more likely than unexposed workers to have abnormal changes related to various cell functions including cell growth and cell death.  This study, published in the peer-reviewed journal PLOS ONE, is the first to look at these cellular changes in blood samples from workers exposed to multi-walled carbon nanotubes.  According to NIOSH, since this study had only a small number of participants, large-scale studies are needed to determine whether the observed ribonucleic acid (RNA) changes are useful markers of exposure in workers.  Additional work also is needed to determine if the effects observed are specific to the multi-walled carbon nanotubes and if this information can assist in developing good risk management practices.  The investigators recommended that these findings be considered when comparing the results from similar studies in the U.S., such as an ongoing study at NIOSH; and
  • Fibrosis Biomarkers in Workers Exposed to MWCNTs: Workers exposed to multi-walled carbon nanotubes were significantly more likely than non-exposed workers to have cellular changes that correlated with lung inflammation and scarring.  NIOSH states that these findings, published in the peer-reviewed journal Toxicology and Applied Pharmacology, underscore the importance of implementing strict control measures as a reasonable precaution to prevent exposure to workers handling multi-walled carbon nanotubes.  The findings indicate that future studies should consider using the observed biomarkers to assess the health effects of workplace exposure to multi-walled carbon nanotubes.  In addition, according to investigators, a repository of biological samples would be a valuable tool for future studies.

nanoIndEx Publishes Guidance Document on Assessment of Personal Exposure to Airborne Nanomaterials

Posted in International, Legal/Regulatory Issues, Occupational Health and Safety Issues

In June 2016, the “Assessment of Individual Exposure to manufactured nanomaterials by means of personal monitors and samples” (nanoIndEx) project published a guidance document entitled Assessment of Personal Exposure to Airborne Nanomaterials.  The three-year project was funded under the Safe Implementation of Innovative Nanoscience and Nanotechnology (SIINN) European Research Area Network (ERA-NET).  Its aim was to determine the field readiness and usability of the instrumentation available for personal exposure assessment; use this information to generate reliable data on personal exposure in real workplaces; and distribute the findings to stakeholders.  The guidance document summarizes the key findings of the project, and is intended to present the state of the art in personal exposure assessment for nanomaterials.  The conclusions section states:  “Unfortunately, many nanotoxicological studies have used excessive, unrealistically high doses of [manufactured nanomaterials] and it is therefore debatable what their findings mean for the lower real-world exposures of humans.  Moreover, it is not clear how to establish realistic exposure dose testing in toxicological studies, as available data on occupational exposure levels are still sparse.”  According to the guidance document, future studies should focus on the potentially adverse effects of low-level and realistic exposure to manufactured nanomaterials, especially through the use of exposure doses similar to those identified in environmental sampling.

FSANZ Publishes Reports on the Use of Nanotechnology in Food Additives and Packaging

Posted in International, Research

In June 2016, Food Standards Australia New Zealand (FSANZ) announced the availability of two reports on the potential use of nanotechnologies in existing food additives and food packaging.  FSANZ retained an expert toxicologist to review publicly available scientific literature on whether there is reasonable evidence of health risks associated with oral ingestion of titanium dioxide, silicon dioxide, and silver in food.  These food additives may contain a proportion of material with at least one dimension in the nanoscale range.  As an extension of this work, the consultant also investigated evidence of risks to health from nanomaterials used in food packaging.  FSANZ states that the key findings include:

  • The consultant reviewed the evidence on nanoscale silicon dioxide, titanium dioxide, and silver in food and found the weight of evidence does not support claims of significant health risks for food grade materials;
  • Titanium dioxide and silicon dioxide are used internationally in a range of food products and have been used safely for decades. They are approved food additives in Australia and New Zealand.  Silver is also an approved additive in Australia and New Zealand but is permitted in very few foods;
  • Overall, the findings of the report are consistent with recently published information in the Organization for Economic Cooperation and Development’s Working Party on Manufactured Nanomaterials Sponsorship Program for the Testing of Manufactured Nanomaterials toxicological dossiers on silicon dioxide, titanium dioxide, and silver;
  • There is no direct evidence to suggest novel nanomaterials are currently being used in food packaging applications in Australia or New Zealand, with most patents found from the U.S.;
  • From the case studies on the use of nano-clay and nanosilver in packaging, the report concludes that there is no evidence from the literature of migration of nano-clay from packaging into food. The nanoscale nature of nanosilver (whether used in packaging or food) is also not likely to be dangerous to consumers’ health; and
  • An independent peer review agreed with the overall analysis and conclusions of both reports stating that they were appropriately balanced in their reporting and that none of the nanotechnologies described are of health concern.

Presentations Available from International Symposium on Asbestos-Like Fibers from Nanomaterials and Other Advanced Materials

Posted in International, Legal/Regulatory Issues, Occupational Health and Safety Issues

On June 14, 2016, Germany’s Federal Institute for Occupational Safety and Health (BAuA) posted the presentations from the April 20, 2016, symposium, “WHO fibres from nanomaterials and other advanced materials:  Do we have to tackle a new asbestos problem in OSH?”  The goal was to initiate a transdisciplinary debate among representatives from academia, regulatory agencies, industry, and other interested parties in the governance landscape on advanced materials.  It was also addressed to the members of the World Health Organization (WHO) Guideline Development Group, “WHO Guidelines on Nanomaterials and Workers’ Health,” which held a face-to-face meeting on April 18-19, 2016.  Presentations include:

ECHA Consults PEGs on Nanomaterial Guidance Documents

Posted in International, Legal/Regulatory Issues

The European Chemicals Agency (ECHA) recently submitted several draft guidance documents concerning nanomaterials to Partner Expert Groups (PEG) for consultation.  Following consultation with PEGs, ECHA will consult its committees and/or Forum, where relevant.  The final consultation will be with the European Commission (EC) and the relevant Competent Authorities.  To ensure that the guidance updating process is transparent and open to participation by relevant partners, ECHA will publish drafts of the texts and feedback from the different consultation steps on its website.  According to the website, feedback on ECHA guidance can be provided by any party by using the guidance feedback form.

ECHA submitted the following draft information requirements and chemical safety assessment (IR&CSA) appendices on recommendations for nanomaterials for environmental endpoints to a PEG for consultation:

  • Appendix R7-1 Recommendations for nanomaterials applicable to Chapter R7a Endpoint specific guidance. This document was prepared by the ECHA Secretariat for the purpose of this consultation and includes only the parts open for the current consultation, i.e.:
    • Update of section 2.1.1 on sample preparation to provide specific indications on the parameters for characterization, pre-requisites, and preparation as monitoring awaited for any nanomaterial;
    • Update of section 2.2.1 on water solubility to include alternative guidelines that could be used for this endpoint and to flag the non-applicability for insolubility as a waiver for other endpoints;
    • Update of section 2.2.2 on partition coefficient n-octanol/water to strengthen the message that guidelines recommended for this endpoint for non-nanomaterials are not applicable for nanomaterials and recommend other parameters that could be considered instead; and
    • Update of section 2.2.4 on adsorption/desorption to clarify that the methods recommended in the parent guidance for this endpoint are not applicable for nanomaterials and recommend other parameters that could be considered instead.
  • Appendix R7-1 Recommendations for nanomaterials applicable to Chapter R7b Endpoint specific guidance. The draft notes that the numbering of the sections has changed.  It includes the following changes, and the following section numbers refer to the updated numbering of the guidance:
    • New advisory note (section 1.1) on testing for ecotoxicity and fate to provide overall advice for conducting ecotoxicity and environmental fate testing for nanomaterials;
    • Update of section 1.2.1 on aquatic pelagic toxicity to clarify that high insolubility cannot be used as a waiver and to include further recommendations on the text to be performed for this endpoint;
    • Update of section 1.2.2. on toxicity for sediment organisms to provide advice on spiking methods and include applicability of available Organization for Economic Cooperation and Development (OECD) guidelines; and
    • Update of section 1.2.3 on degradation/biodegradation to clarify that waivers for hydrolysis and degradation simulation testing are not applicable as sole evidence, and provide advice on photocatalytic degradation and general advice on performing the tests.
  • Appendix R7-2 Recommendations for nanomaterials applicable to Chapter R7c Endpoint specific guidance. This document was prepared by the ECHA Secretariat for the purpose of this consultation and includes only the parts open for the current consultation, i.e.:
    • Update of section 2.1.1. on aquatic bioaccumulation to explain the general limitations of the octanol-water partitioning coefficient (Kow) as the basis for a waiver for nanomaterials and provide advice on the applicability of the available OECD guidelines; and
    • Update of section 2.1.2 on effects on terrestrial organisms to provide advice on spiking methods and use of different metrics.

A different PEG is reviewing Appendix 4:  Recommendations for nanomaterials applicable to the Guidance on Registration.  ECHA developed the draft Appendix to provide advice to registrants preparing their registration dossiers for nanomaterials.  The aim of the Appendix is to define the term “nanoform,” the minimum criteria for distinguishing between different nanoforms, and the minimum set of parameters that must be reported to characterize a reported nanoform.  According to the draft Appendix, a “nanoform” is a form of a substance that meets the requirements of the EC definition of a nanomaterial and always has a specific shape and a specific surface chemistry as additional parameters.  The three minimum elements for defining a nanoform are:  (1) whether it meets the EC recommendation on the definition of a nanomaterial; (2) its shape; and (3) its surface chemistry.  ECHA notes that these are simply the minimum elements necessary to characterize registered nanoforms in a registration dossier.  Depending on the substance, additional elements and/or additional refinement of these elements (i.e., specific size ranges, specific shapes, etc.) may need to be reported depending on their impact on properties as determined in the data collected/generated to fulfill information requirements.  The draft Appendix states:  “Where nanoforms are not reported transparently in the registration dossier for the substance, it is understood as an explicit statement made by the registrants of that substance that nanoforms are not within the scope of their registered substance.”  The minimum parameters to be reported when nanoforms are registered are:  (1) size; (2) shape; and (3) surface chemistry.

A PEG is consulting on Appendix R.6-1:  Recommendations for nanomaterials applicable to the Guidance on QSARs and Grouping.  ECHA intends the document to provide an approach on how to justify the use of hazard data between nanoforms of the same substance, and it is presented as an Appendix to Chapter R.6 of the Guidance on IR&CSA on quantitative structure-activity relationships (QSAR) and grouping “because general concepts on grouping of chemicals are applicable to [nanomaterials].”

A PEG is consulting on Appendix R7-1 Recommendations for nanomaterials applicable to Chapter R7a Endpoint specific guidance and Appendix R7-2 Recommendations for nanomaterials applicable to Chapter R7c Endpoint specific guidance.  This document is a proposed amendment to specific extracts only of the following guidance documents:  Appendix R7-1 to Chapter R.7a. (section 3 only); and Appendix R7-2 to Chapter R7c (section 2.1.3 only).

UK Nanosafety Group Publishes Updated Guidance to Support Safe Working with Nanomaterials

Posted in International, Legal/Regulatory Issues

In May 2016, the UK Nanosafety Group (UKNSG) published a second edition of its guidance document, Working Safely with Nanomaterials in Research & Development.  The second edition of the guidance provides updates to account for changes in legislation, recent studies in the literature, and best practice since 2012.  In particular, according to the guidance, specific sections have been revised to account for the full implementation of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS), which came into force on June 1, 2015, through the Classification, Labeling, and Packaging (CLP) Regulation.  The document explains the approaches that are presently being used to select effective control measures for the management of nanomaterials, more specifically control banding tools presently in use.  Significant changes were made in the sections “Hazard Banding,” “Exposure Control,” “Toxicology,” and “Monitoring.”  The document draws attention to the possible health hazards that could result from exposure to particulate nanomaterials and provides advice on the precautions that may be needed to prevent or control adequately exposure as required by the Control of Substances Hazardous to Health Regulations (COSHH) 2002 (as amended).  The aim of the document is to offer guidance on factors relating to establishing a safe workplace and good safety practice when working with particulate nanomaterials, which are defined as “nanomaterials that consist of nano-objects such as nanoparticles, nanofibres, nanotubes, nanowires, as well as aggregates and agglomerates of these materials either in their original form or incorporated in materials or preparations, from which they could be released.”  The guidance is aimed at employers, managers, health and safety advisors, and users of particulate nanomaterials in research and development.  The document advocates a precautionary strategy to minimize potential exposure.

Lynn L. Bergeson Will Speak at 15th Annual NanoBCA Conference

Posted in United States

Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®), will speak at the NanoBusiness Commercialization Association’s (NanoBCA) 15th Annual Conference, which will be held June 14, 2016, in New York City, New York. The conference will include leading experts from private industry who are commercializing nanomaterials. Nanotechnology leaders such as Jim Phillips, Chairman and Chief Executive Officer (CEO) of NanoMech, Charles van Fleet, President of Swan Chemical, Doyle Edwards, Government Programs Director of Brewer Science, Dr. Matthew Putman, CEO of Nanotronics Imaging, and many more will be presenting at the event. NanoBCA is a non-profit trade organization dedicated to creating a political environment that nurtures research and innovation in nanotechnology, promotes tech-transfer of nanotechnologies from academia to industry, encourages private capital investments in nanotechnology companies, and helps its company members bring innovative nanotechnology products to the market.

Mexico Begins Public Consultation on Draft Nanotechnology Standards

Posted in International, Legal/Regulatory Issues

On May 3, 3016, Mexico’s Ministry of Economy published a notice beginning a public consultation on two draft nanotechnology standards.  Proposed standard PROY-NMX-R-80004-5-SCFI-2015 is identical to ISO/TS 80004-5:2011, “Nanotechnologies — Vocabulary — Part 5:  Nano/bio interface.”  ISO/TS 80004-5:2011 lists terms and definitions related to the interface between nanomaterials and biology.  It is intended to facilitate communications between scientists, engineers, technologists, designers, manufacturers, regulators, non-governmental organizations (NGO), consumer organizations, members of the public, and others.  Proposed standard PROY-NMX-R-12901-1-SCFI-2015 is identical to ISO/TS 12901-1:2012, “Nanotechnologies — Occupational risk management applied to engineered nanomaterials — Part 1:  Principles and approaches.”*  ISO/TS 12901-1:2012 provides guidance on occupational health and safety measures relating to engineered nanomaterials, including the use of engineering controls and appropriate personal protective equipment, guidance on dealing with spills and accidental releases, and guidance on appropriate handling of these materials during disposal.  It is intended for use by competent personnel, such as health and safety managers, production managers, environmental managers, industrial/occupational hygienists, and others with responsibility for the safe operation of facilities engaged in production, handling, processing, and disposal of engineered nanomaterials.  Publication of the notice began a 60-day public comment period.

*  The notice cites standard ISO/TS 12901-1:2012 but provides an incorrect title, “Guidance on the labelling of manufactured nano-objects and products containing manufactured nano-objects.  Part 1 — Principles and approaches.”  We have provided the correct title of the standard, which matches the title of the draft Mexican standard.

Germany Publishes Report on Nanomaterials in the Environment

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

On June 1, 2016, the German Environment Agency (UBA) published a report entitled Nanomaterials in the environment:  Current state of knowledge and regulations on chemical safety.  The aim of the report is to outline the necessary further development of chemicals regulations for nanomaterials with regard to the environment from UBA’s perspective.  The report is addressed “particularly to players and decision-makers involved in discussions related to the adaptation of the various regulations on chemical safety.”  The report presents the current state of knowledge about the environmental behavior and the effects of nanomaterials; considers general aspects of regulatory needs such as the definition of nanomaterials, their characterization, and the assessment of related risks; and describes the current consideration of nanomaterials in the existing active substance regulations and the specific requirements for adaptions.  The report states that, in the view of UBA, the European Commission (EC) should expedite the implementation of the definition proposal of nanomaterials in regulations on the safety of chemicals, as well as the implementation of nanomaterial specific requirements into the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation “in a constructive manner.”  With regard to the implementation and further development of the regulations of concern and the required risk assessment instruments, UBA “will continue to cooperate closely” with the Federal Institute for Occupational Safety and Health, the Federal Institute for Risk Assessment, the Federal Office for Chemicals, and the Federal Ministry of the Environment, as well as the representatives of the other European Union Member States, the European Chemicals Agency, the European Food Safety Agency, the European Medicine Agency, the EC, and the Organization for Economic Cooperation and Development.  According to the report, the nanomaterials research strategy developed in cooperation with other higher federal authorities is still being pursued.  The report states:  “The steady progress of advancement of nanomaterials has to be observed carefully in order to ensure that the adaptations of individual instruments for risk assessment currently being called for and discussed will still be adequate in the future.”