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 Report Highlighting Second Decade of Research Agenda Includes Nano Developments

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

On August 10, 2017, the National Institute for Occupational Safety and Health (NIOSH) published a report entitled National Occupational Research Agenda:  Second Decade in Review | 2006-2016.  The report outlines the progress and impact made in addressing occupational safety and health research needs over the second decade of the National Occupational Research Agenda (NORA).  The 21 cross-sector programs included in the report include the Nanotechnology Program, which “conducts research and promotes adoption of approaches to reduce adverse effects of exposures to materials containing structures with a length scale below 100 nanometers.”  Impact stories in the report include:

  • NIOSH Recommended Exposure Limits (REL) for carbon nanotubes and titanium dioxide provided the U.S. Environmental Protection Agency (EPA) with information to develop regulations to protect workers who handle engineered nanomaterials;
  • NIOSH methods to measure protective clothing’s resistance to nanoparticles contributed to new guidance documents, requirements, and test methods from other government agencies, organizations, and manufacturers;
  • NIOSH work led to the Occupational Safety and Health Administration (OSHA) and EPA developing recommendations for working with multi-walled carbon nanotubes;
  • The NIOSH virtual Nanotechnology Research Center (NTRC) has supported or influenced more than 90 researchers in pioneering studies to understand better the potential occupational health and safety risks in the nanotechnology industry, and to incorporate effective precautions as the industry grows;
  • NIOSH work to measure nanoparticles penetrating respirators informs researchers and organizations developing new or revised standards in this area; and
  • NIOSH scientists invented a way to suspend carbon nanotubes in air while controlling the concentration of particles. The report states:  “This was a true breakthrough because it was the first time a well-characterized controlled aerosol of a carbon nanotube had been generated, providing a resource for studies on these minute particles, whose properties and characteristics are not well understood.”

In addition to the main report, NIOSH published the Sector and Cross Sector Program Supplement, which provides program-specific results on the work of each of the ten NORA sectors and 24 cross-sector programs developed by NIOSH to support the NORA sector program goals and objectives.  According to the report, the mission of the NIOSH Nanotechnology Cross-Sector Program is to provide national and international leadership in investigating the implications of nanoparticles and nanomaterials for work-related injury and illness, and to explore their potential applications in occupational safety and health.  NTRC developed an effective program of research resulting in a better understanding of the hazards of nanomaterials; methods to evaluate potential areas for worker exposures; guidance on hazard evaluation and risk assessment, including RELs; a framework for human health evaluation; guidance on engineering control strategies to minimize exposures; and general risk management guidance that ensures worker protection and promotes responsible development of nanotechnology.  The report states that onsite evaluations of nanomanufacturing process investigations allowed NIOSH to measure worker exposures and develop recommendations for techniques to control and mitigate exposures.  Key outcomes include actions from companies that have modified engineering controls, work practices, and in-house RELs.  NTRC-authored publications have been cited more than 5,000 times in the peer reviewed scientific literature; the primary citations have resulted in over 82,000 secondary citations.

EPA Publishes Final Guidance as Final TSCA Section 8(a) Rule Takes Effect

Posted in Federal, Legal/Regulatory Issues, United States

On August 14, 2017, as the final Toxic Substances Control Act (TSCA) Section 8(a) information gathering rule on nanomaterials took effect, the U.S. Environmental Protection Agency (EPA) published “working guidance” intended to assist stakeholders in complying with the rule.  The working guidance notes that it “will not provide answers to all of the potential questions that will arise as manufacturers and processors seek to comply with the rule.  Commenters to the draft guidance asked several questions that would require more details or information before EPA could respond to their question.”  If the guidance does not answer questions about the rule, companies are directed to contact Jim Alwood, Chemical Control Division, Office of Pollution Prevention and Toxics, alwood.jim@epa.gov.  EPA states that it will answer questions on a case-by-case basis.  EPA intends to add further questions/answers and revisions to the guidance based on questions identified by persons who may be subject to the rule.  As reported in our January 11, 2017, blog item, the January 12, 2017, final rule establishes reporting and recordkeeping requirements for certain discrete forms of chemical substances that are manufactured or processed at the nanoscale.  Under the rule, manufacturers and processers, or persons who intend to manufacture or process these chemical substances must report certain information to EPA.  The information to be reported includes, insofar as known to or reasonably ascertainable by the person making the report, the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing information concerning environmental and health effects.  Persons who manufacture or process a discrete form of a reportable chemical substance at any time during the three years prior to August 14, 2017, the effective date of the final rule, must report to EPA one year after the effective date of the final rule.  There is also a standing one-time reporting requirement for persons who intend to manufacture or process a discrete form of a reportable chemical substance on or after the effective date of the rule.  These persons must report to EPA at least 135 days before manufacture or processing of that discrete form.  More information regarding the final rule is available in our January 12, 2017, memorandum, “EPA Promulgates Final TSCA Reporting and Recordkeeping Rule for Nanoscale Materials.”

ClientEarth Files Complaint with EU Ombudsman over EC Catalog of Nanomaterials Used in Cosmetic Products

Posted in International, Legal/Regulatory Issues

ClientEarth announced on July 31, 2017, that it filed a complaint with the European Union (EU) Ombudsman about the European Commission’s (EC) “unlawful handling of a long-delayed list of nano-chemicals in cosmetics.”  As reported in our June 19, 2017, blog item, the EC published June 15, 2017, a catalog of nanomaterials used in cosmetic products on the EU market.  ClientEarth states that “[d]espite the lengthy delay, the list still does not let people identify which cosmetics contain potentially harmful nanomaterials, or assess the threat they may pose to human health.”  ClientEarth calls on the EU Ombudsman — “an independent and impartial EU body” — to “open an investigation into these acts of maladministration and hold the Commission to account for frustrating consumers’ and civil society’s rights to know about the risks of products people use every day.”

EC Publishes NanoData Landscape Compilation Reports

Posted in International, Legal/Regulatory Issues

On June 8, 2017, the European Commission (EC) published eight NanoData Landscape Compilation reports.  The EC states that the reports offer a snapshot of the environment for nanotechnology in different application fields:

  • NanoData Landscape Compilation: Health:  This report offers a snapshot of the status of the environment for nanotechnology in the context of health.  Analysis of that environment, trends in the data, and the effects of European policies and actions on health nanotechnology will be reported in the NanoData Health Impact Assessment and are therefore not included in this report;
  • NanoData Landscape Compilation: Manufacturing:  This report offers an overview of policies and programs for nanotechnology manufacturing in the European Union (EU), publications, patenting, research and innovation, industry, products and markets, and the wider environment;
  • NanoData Landscape Compilation: Information and Communication Technologies:  This report offers a snapshot of the environment for nanotechnology in the context of information and communication technologies (ICT).  It gives an overview of policies and programs for nanotechnology and ICT in the EU, publications, patenting, research and innovation, industry, products and markets, and the wider environment;
  • NanoData Landscape Compilation: Transport:  Transport is defined here as a sector based on vehicles for transporting people and/or goods via the air, rail, road, water, and space, and is here divided into two main areas, vehicles and infrastructure.  The industry generates about five percent of European employment and seven percent of European gross domestic product (GDP).  Transport is also responsible for the emission of nearly 25 percent of greenhouse gases in the EU, however;
  • NanoData Landscape Compilation: Energy:  Nanotechnology has the potential to contribute to energy sustainability by reducing consumption, improving the infrastructure for energy generation, transmission, and use, and offering new methods for energy production.  To achieve this, the field of nanotechnology and energy needs to have a solid research base; routes for new developments in energy technology to be further advanced and commercialized; and a market open to nanotechnology energy products, in the context of appropriate regulation and standards.  The European Energy Strategy is seeking to tackle that challenge through measures to improve energy efficiency, increase the share of renewable energy, and reduce greenhouse gases.  This report looks, from a research, development and deployment (market) perspective, at the role of nanotechnology in achieving those energy goals and at the overall landscape in Europe for nanotechnology and energy;
  • NanoData Landscape Compilation: Construction:  This report offers a snapshot of the status of the environment for nanotechnology in the context of construction.  The construction industry covers the building, maintaining, and repairing of buildings and infrastructures for living, working, and transport, including providing materials for those purposes.  The sector is a major consumer of raw materials, chemicals, energy and intermediate products such as electrical equipment, as well as services;
  • NanoData Landscape Compilation: Environment:  This report offers a snapshot of the status of nanotechnology in the context of the environment.  Nanotechnology is one of the emerging technologies that can help to prevent or remediate environmental degradation and improve monitoring (direct effect), or lead to reduced energy and resource consumption (indirect effect).  Introducing new substances, such as nanomaterials and nanoparticles with unknown characteristics, into the environment may have negative environmental and health effects, however.  Aspects of nanotechnology both for and in the environment are covered in this report; and
  • NanoData Landscape Compilation: Photonics:  Nanoscale effects impact on photonics, g., in the surface quality of waveguides and optical fibers.  The focus here remains as closely as possible on photonics as it relates to nanotechnology, e.g., where nanotechnology enhances photonics and vice versa.

NIEHS Using Survey to Update 2012-2017 Strategic Plan

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

Dr. Linda S. Birnbaum, Director, National Institute of Environmental Health Sciences (NIEHS), wrote an editorial in Environmental Health Perspectives on “Updating the NIEHS Strategic Plan.”  According to Birnbaum, NIEHS is developing a plan to guide its next five years and seeks broad input.  NIEHS has created an online survey, “Trends & Insights: Next Steps for NIEHS,” through which stakeholders can provide feedback on the existing Strategic Plan, as well as offer any other relevant comments.  The 2012-2017 Strategic Plan includes 11 Strategic Goals.  Goal Five, “Identify and respond to emerging environmental threats to human health, on both a local and global scale,” includes “[f]ocus[ing] on research needs to help inform policy responses in public health situations in which lack of knowledge hampers policymaking, e.g., health effects of exposures related to hydrofracking or climate change, or exposures to engineered nanomaterials.”  The survey will be available until August 11, 2017.  Birnbaum states that the results, along with input collected in other venues, will help to inform a draft Strategic Plan that NIEHS anticipates making available for review later in 2017.

USDA Awards $4.6 Million in Nanotechnology Research Grants

Posted in Federal, Research, United States

On July 20, 2017, the United States Department of Agriculture (USDA) National Institute of Food and Agriculture (NIFA) announced 13 grants worth $4.6 million for research on the next generation of agricultural technologies and systems to meet the growing demand for food, fuel, and fiber.  NIFA states that funded projects support nanotechnology-based solutions that improve food production, nutrition, sustainable agriculture, and food safety.  The announced grants include:

  • Kansas State University, Manhattan, Kansas, $450,200;
  • Wichita State University, Wichita, Kansas, $340,000;
  • University of Massachusetts, Amherst, Massachusetts, $444,550;
  • University of Nevada, Las Vegas, Nevada,$150,000;
  • North Dakota State University, Fargo, North Dakota, $149,000;
  • Cornell University, Ithaca, New York, $455,000;
  • Cornell University, Ithaca, New York, $450,200;
  • Oregon State University, Corvallis, Oregon, $402,550;
  • University of Pennsylvania, Philadelphia, Pennsylvania, $405,055;
  • Gordon Research Conferences, West Kingston, Rhode Island, $45,000;
  • The University of Tennessee, Knoxville, Tennessee, $450,200;
  • Utah State University, Logan, Utah, $450,200; and
  • The George Washington University, Washington, D.C., $450,200.

According to NIFA, the University of Pennsylvania project will engineer cellulose nanomaterials with high toughness for potential use in building materials, automotive components, and consumer products, while the University of Nevada project will develop a rapid, sensitive test to detect Salmonella typhimurium to enhance food supply safety.  NIFA notes that previously funded grants include an Iowa State University project in which a low-cost and disposable biosensor made out of nanoparticle graphene that can detect pesticides in soil was developed.  University of Minnesota researchers created a sponge that uses nanotechnology to absorb quickly mercury, as well as bacterial and fungal microbes from polluted water.

NIOSH Submits Proposed Survey to OMB, Will Accept Comments for 30 Days

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

On July 17, 2017, the National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice announcing it submitted a proposed information collection to the Office of Management and Budget for review and approval.  The proposed project is “Survey of Engineered Nanomaterial Occupational Safety and Health Practices.”  As reported in our February 14, 2017, blog item, NIOSH invited comment on the proposed survey on February 10, 2017.  NIOSH will survey companies that manufacture, distribute, fabricate, formulate, use, or provide services related to engineered nanomaterials.  NIOSH will compile a sample of 600 companies from lists of industry associations, research reports, marketing databases, and web-based searches.  Of the 600 selected companies, NIOSH states that it anticipates that 500 will complete the survey within two years.  The goal of the project is to assess the relevance and impact of NIOSH’s contribution to guidelines and risk mitigation practices for safe handling of engineered nanomaterials in the workplace.  The intended use of the data is to inform NIOSH’s research agenda to enhance its relevance and impact on worker safety and health in the context of engineered nanomaterials.  Publication of the July 17, 2017, Federal Register notice began a 30-day comment period.

EC Publishes Final Report of Nanocomput Project

Posted in International, Legal/Regulatory Issues, Research

In July 2017, the European Commission’s (EC) Joint Research Center (JRC) published a report entitled Evaluation of the availability and applicability of computational approaches in the safety assessment of nanomaterials:  Final report of the Nanocomput project.  The main aims of the Nanocomput Project were to review and assess the current status of computational methods that are potentially useful for predicting the properties of engineered nanomaterials to provide advice on the use of these approaches for the purposes of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  The Project emphasized quantitative structure-property relationship (QSPR) and quantitative structure-activity relationship (QSAR) models, and their potential role in predicting nanomaterial properties.  In addition, the Nanocomput Project assessed the status of a diverse array of compartment-based mathematical models.  These models comprised toxicokinetic, toxicodynamic, in vitro and in vivo dosimetry, and environmental fate models.  The report includes overall conclusions from the Nanocomput Project, including lessons learned in conducting literature reviews and research-based case studies on grouping and read-across.  It offers a number of recommendations intended to overcome current shortcomings in the knowledge of nanomaterial behavior and in the availability of tools (such as databases and predictive models) and practical guidance to use such tools in the regulatory assessment of nanomaterials.

NIOSH Publishes Chapter on Analysis of Carbon Nanotubes and Nanofibers on Filters by Transmission Electron Microscopy

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

The National Institute for Occupational Safety and Health (NIOSH) has published a chapter in the fifth edition of the NIOSH Manual of Analytical Methods (NMAM) entitled “Analysis of Carbon Nanotubes and Nanofibers on Mixed Cellulose Ester Filters by Transmission Electron Microscopy.”  The draft chapter provides standardized approaches for the analysis of carbon nanoparticles.  The chapter provides detailed guidance on effective means to perform transmission electron microscopic analysis on carbon nanotubes and nanofibers that are sampled from occupational atmospheres.  The chapter notes that, with respect to quantification, it is important to recognize the limitations of a particle counting method.  According to the chapter, because of the heterogeneity of carbon nanotube powders, particles in the same size bin can vary greatly in their properties.  Complex structures of varying mass, density, shape, and composition (e.g., amorphous carbon, residual catalyst) can fall into the same size bin, and dissimilar particles (e.g., cluster and matrix) in a given bin may have different toxicological effects.  Thus, the chapter states, “even for a given material, particle envelope size alone may not be an adequate risk indicator.”  Given the heterogeneity and variety of the carbon nanotube/carbon nanofiber products to which workers are exposed, “it is important to apply several methods to assess worker exposure, through inhalation and other routes.”

EPA Regulatory Agenda Item Revised to Remove, Then Add Back TBD Effective Date

Posted in Federal, Legal/Regulatory Issues, United States

Since July 20, 2017, when the Trump Administration published its Unified Agenda of Regulatory and Deregulatory Actions, the entry for the U.S. Environmental Protection Agency’s (EPA) item (RIN 2070-AJ54) concerning the Toxic Substances Control Act (TSCA) Section 8(a) reporting rule for nanoscale materials has been revised at least twice.  As reported in our July 20, 2017, blog item, the Unified Agenda item stated that the final rule effective date is “To Be Determined” (TBD).  On July 22, 2017, the timetable in the Unified Agenda entry, which listed the TBD effective date, had been removed.  Today, July 24, 2017, the timetable is visible again.  The January 12, 2017, final rule requires one-time reporting for existing discrete forms of certain nanoscale materials, and a standing one-time reporting requirement for new discrete forms of certain nanoscale materials.  As reported in our May 12, 2017, blog item, on May 12, 2017, EPA published a Federal Register notice delaying the effective date of the January 12, 2017, rule’s reporting requirements from May 12, 2017, to August 14, 2017.  More information regarding the draft guidance on the rule is available in our May 16, 2017, memorandum, “EPA Seeks Comment on Draft Guidance for Nanoscale Materials Reporting Rule.”  More information on the final rule is available in our January 12, 2017, memorandum, “EPA Promulgates Final TSCA Reporting and Recordkeeping Rule for Nanoscale Materials.”