Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

NGOs Call for Actions, Not Words, from the EC on Nanotechnology

Posted in International, Legal/Regulatory Issues

On April 26, 2016, a group of non-governmental organizations (NGO), consumer groups, and research organizations issued a press release expressing “disappointment with the European Commission’s [(EC)] continuing failure to propose adequate measures for the collection and publication of information about nanomaterials on the [European Union (EU)] market after a Commission meeting with stakeholders in Brussels on Monday.” The press release criticizes the EC for deciding against an EU-wide nanomaterial registry before completing the impact assessment process. Instead, according to the press release, the EC asked the European Chemicals Agency (ECHA) to develop a nanomaterial observatory as part of its 2015-18 nanomaterials work plan. The press release states that the April 25, 2016, meeting “was supposed to provide more details about this new mechanism, but in reality it provided little hope that the observatory will be able to address the pressing information gaps about nanomaterials on the market.”

SCOEL Discusses Nanomaterials during March Meeting

Posted in International, Occupational Health and Safety Issues

The European Commission’s (EC) Scientific Committee on Occupational Exposure Limits (SCOEL) met on March 7-9, 2016. The meeting minutes include the following summary regarding SCOEL’s discussion of nanomaterials:

Several chemical agents proposed or envisaged to be addressed by SCOEL do concern or also concern the form as nanomaterial. SCOEL identified a group of scientists to organise a workshop or expert meeting in order to prepare for dealing with the subject in specific and take into account latest state-of-the-art. The lead is with MvT, who will organise the workshop/expert meeting in close collaboration with the Secretariat and the Board.

An update was provided. In view of the enhanced needs for cooperation with [the European Chemicals Agency] and the tight schedule, the nanomaterials and [occupational safety and health] workshop will be planned for 2017.

Registration Now Open for 2016 U.S.-EU: Bridging NanoEHS Research Efforts Joint Workshop

Posted in International, Research, United States

Registration is now open for the June 6-7, 2016, U.S.-European Union (EU) “Bridging NanoEHS Research Efforts” joint workshop.  The workshop will bring together the U.S.-EU Communities of Research (COR), which serve as a platform for U.S. and EU scientists to share information on nanotechnology environmental, health, and safety (nanoEHS) research.  The goal of the workshop is to publicize progress towards COR goals and objectives, clarify and communicate future plans, share best practices, and identify areas of cross-COR collaboration.  The workshop will also feature a COR-led nanoEHS scrimmage in which the communities will collectively respond to a hypothetical spill of a nanotechnology-enabled product.  The workshop is free and open to the public with registration on a first-come, first-served basis.

SNWG Submits Comments on NIOSH Draft CIB on Silver Nanomaterials

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

On April 18, 2016, the Silver Nanotechnology Working Group (SNWG) submitted comments on the National Institute for Occupational Safety and Health’s (NIOSH) draft NIOSH Current Intelligence Bulletin:  Health Effects of Occupational Exposure to Silver Nanomaterials.  The draft Current Intelligence Bulletin (CIB) includes a review and assessment of the currently available scientific literature on the toxicological effects of exposure to silver nanoparticles in experimental animal and cellular systems, and on the occupational exposures to silver dust and fume and the associated health effects.  According to the draft CIB, “[a]lthough the experimental animal and cellular studies are useful for showing potential risks from exposure to silver nanomaterials, NIOSH considers the currently available data to be too limited to develop a [recommended exposure limit (REL)] for silver that is specific to particle size.”  Instead, NIOSH recommends that effective risk management control practices be implemented so that worker exposures to silver nanomaterials do not exceed the NIOSH REL of ten micrograms per cubic meter (μg/m3) (eight-hour time-weighted average) for silver metal dust, fume, and soluble compounds, measured as a total airborne mass concentration.  The SNWG states that, in general, it agrees with NIOSH’s recommendation and the evidence upon which the recommendation is based.  The SNWG “recognizes the uncertainties that NIOSH has concerning the current data on nanosilver particles, but continues to maintain that the toxicity of nanosilver is not significantly different from bulk or dissolved silver (colloidal silver).”  The SNWG states that it “confirms NIOSH’s recommendation that if companies manufacturing and making use of nanosilver particles implement effective risk management control practices so that worker exposures to all forms of silver, including silver nanomaterials,” do not exceed the NIOSH REL for silver metal dust, fume, and soluble compounds measured as a total airborne mass concentration, “their workers will be more than adequately protected from any potential harmful exposures to all forms of silver, including nanosilver.”  Regarding the research needs discussed in Section 8 of the draft CIB, the SNWG states that one of its functions is to identify, gather, and consolidate industry data in an anonymous manner to protect confidential business information.  If NIOSH needs such a mechanism to obtain any needed data, the SNWG has offered to serve in such a capacity.

European Organizations Issue Declaration on Waste Containing Nanomaterials

Posted in International, Legal/Regulatory Issues

On April 13, 2016, the Center for International Environmental Law (CIEL), the European Environmental Citizens’ Organization for Standardization (ECOS), and the Oeko-Institut issued a press release announcing the availability of the Declaration on Waste Containing Nanomaterials.  According to the press release, over 80 signatories have endorsed the Declaration, “demonstrating overwhelming support for the demand to categorize waste containing manufactured nanomaterials as hazardous waste.”  The Organization for Economic Cooperation and Development’s (OECD) February 2016 report, Nanomaterials in Waste Streams:  Current Knowledge on Risks and Impacts, “underpins the Declaration’s call to limit the potential presence of nanotechnology in waste streams.”  The Declaration calls for governments, research and innovation funding institutions, and companies to:

  • Implement full producer responsibility to ensure safe management of waste containing manufactured nanomaterials;
  • Restrict transboundary movements of waste containing certain manufactured nanomaterials;
  • Enable transparent quantification and characterization of waste flows containing manufactured nanomaterials through a European Union (EU)-wide public nano-product registry;
  • Stimulate innovation on waste prevention;
  • Foster the development of safe and effective recycling and disposal technologies for products containing manufactured nanomaterials;
  • Develop and establish verifiable end-of-waste criteria for recyclable materials containing manufactured nanomaterials; and
  • Innovators should explore how advanced properties of manufactured nanomaterials can be employed in support of the circular economy without introducing new environmental risks or aggravating existing ones.

OSTP Blog Item Notes Recent Reports Highlighting Continued Federal Commitment To NanoEHS

Posted in Federal, Legal/Regulatory Issues, United States

The Office of Science and Technology Policy (OSTP) posted on April 11, 2016, a blog item, authored by Lloyd Whitman, OSTP, and Dr. Treye Thomas, Consumer Product Safety Commission (CPSC), entitled “Supporting Responsible Development of Nanotechnology.”  The item states that the following reports released in March 2016 highlight federal investments and activities in the area of nanotechnology environmental, health, and safety (nanoEHS) research, progress, and needs in understanding exposure from consumer products, and how businesses can protect their nanotechnology workforce:

  • The recently released NNI Supplement to the President’s Budget for Fiscal Year 2017, which serves as the annual report for the National Nanotechnology Initiative (NNI), highlights the programs and coordinated activities taking place across the departments, independent agencies, and commissions participating in the NNI. As detailed in this report, nanoEHS activities continue to account for about ten percent of the annual NNI budget, with cumulative federal research and development investments in this area exceeding $1 billion over the past decade.
  • Last month NNI released a report, Quantifying Exposure to Engineered Nanomaterials (QEEN) from Manufactured Products: Addressing Environmental, Health, and Safety Implications, summarizing a workshop sponsored by CPSC. The main goals of the workshop were to assess progress in developing tools and methods for quantifying exposure to engineered nanomaterials across the product life cycle, and to identify new research needed to advance exposure assessment for nanotechnology-enabled products.
  • The technical experts who participated in CPSC’s workshop recommended that future work focus on determining biomarkers of exposure linked to disease, which will require substantive public-private collaboration, partnership, and knowledge sharing. Recognizing these needs, the President’s 2017 Budget request for CPSC includes funds for a new nanotechnology center led by the National Institute of Environmental Health Sciences (NIEHS) to develop test methods and to quantify and characterize the presence, release, and mechanisms of consumer exposure to nanomaterials in consumer products.
  • The National Institute for Occupational Safety and Health (NIOSH) has issued a series of documents providing guidance intended to protect workers who manufacture nanotechnology products, including the recently released publication Building a Safety Program to Protect the Nanotechnology Workforce: A Guide for Small to Medium-Sized Enterprises. This guide provides business owners with the tools necessary to develop and implement a written health and safety program to protect their employees.

The blog item also notes that an upcoming workshop will explore the work of joint U.S.-European Union (EU) nanoEHS communities of research in developing a shared repertoire of protocols and methods.  The 2016 joint workshop will be held on June 6-7, 2016, in Arlington, VA, and is free and open to the public.  Registration opened on April 6, 2016, on a first-come, first-served basis.

JRC Publishes Report on Harmonized Terminology for EHS Assessment of Nanomaterials

Posted in International, Legal/Regulatory Issues

The European Commission (EC) Joint Research Center (JRC) recently published a report entitled NANoREG harmonised terminology for environmental health and safety assessment of nanomaterials, developed within the NANoREG project:  “A common European approach to the regulatory testing of nanomaterials.”  The report states that it represents the project’s attempt at bringing common understanding and consistency in the use of key terms in the environmental health and safety (EHS) assessment of nanomaterials.  The objective of the report is to publish the harmonized terminology that has been developed and used within NANoREG.  According to the report, all project partners have agreed upon and adopted the terminology in their activities and related documents.  The report specifically includes:  (1) the methodology used to select key terms that form the harmonized terminology and to develop harmonized definitions; (2) the existing literature definitions that have been used as a starting point to develop for each key term a harmonized definition; and (3) the reason(s) behind the choices that have been made in drafting a definition.  The discussion on the key terms to be considered for the harmonized terminology led to the selection of 43 key terms.  The list includes terms with international regulatory relevance, such as those defined at the Organization of Economic Cooperation and Development (OECD) level, as well as terms that have a specific meaning and use under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  According to the report, it has “already proven very useful” in the context of OECD work, as a support document to the April 13-14, 2016, OECD Expert Meeting on “Grouping and read-across for the hazard assessment of manufactured nanomaterials,” and in a regulatory context, as a support document to the work recently released by the National Institute for Public Health and the Environment (RIVM), European Chemicals Agency (ECHA), and JRC on using (eco)toxicological data for bridging data gaps between nanoforms of the same substance.

OECD Publishes Report on Delegation Developments on the Safety of Manufactured Nanomaterials

Posted in Legal/Regulatory Issues, OECD, Research

The Organization for Economic Cooperation and Development recently posted a March 29, 2016, report entitled Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour de Table.  The report compiles information, provided by Working Party on Manufactured Nanomaterials (WPMN) participating delegations, before and after the November 2015 WPMN meeting, on current developments on the safety of manufactured nanomaterials.  OECD intends the report to provide delegations with background information on activities related to manufactured nanomaterials, as well as other activities on nanotechnologies at the international level.  It includes developments from Australia, Austria, Belgium, Canada, Germany, Japan, Korea, the Netherlands, Switzerland, Turkey, United Kingdom, U.S., and the European Commission (EC), as well as the Business and Industry Advisory Committee to the OECD (BIAC) and International Council on Animal Protection in OECD Programs (ICAPO).

NIOSH Publishes Nanotechnology Safety Program Guide for SMEs

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

On April 4, 2016, the National Institute for Occupational Safety and Health (NIOSH) published a report entitled Building a Safety Program to Protect the Nanotechnology Workforce: A Guide for Small to Medium-Sized Enterprises. The report states that employees may be at risk of exposure by inhalation, skin absorption, or ingestion. According to the report, several factors can affect their potential for exposure, including:

  • The route, concentration, duration, and frequency of any exposure;
  • The ability of the nanomaterial to be easily dispersed (such as a dust or aerosol); and
  • The control measures in place to reduce or limit exposures.

The report states that the best way to control potential exposures and to protect workers includes creating and following a risk management plan that incorporates the hierarchy of controls: elimination, substitution, engineering controls, administrative controls, and personal protective equipment. The report lists the following elements that are “the keys to a successful health and safety program”:

  • Leadership by top management;
  • Inclusion of employees;
  • Establishment of a Safety Committee;
  • Creation of a written risk-management plan that includes;
    • Identification of potential hazards;
    • Identification of exposure potential;
    • Establishment of controls following the hierarchy of controls;
    • Verification of controls;
    • Preparation for emergencies; and
    • Regulatory compliance;
  • Continued evaluation of the safety program:
    • Plan, Do, Check, Act.

NNI Publishes Supplement to the President’s 2017 Budget

Posted in Federal, Legal/Regulatory Issues, Research, United States

On March 31, 2016, the National Nanotechnology Initiative (NNI) published its supplement to the President’s 2017 budget request.  The supplement also serves as the NNI annual report called for under the provisions of the 21st Century Nanotechnology Research and Development Act of 2003.  NNI states that the President’s budget request provides $1.4 billion for NNI, with a cumulative total of nearly $24 billion since the inception of NNI in 2001 (including the 2017 request), “affirming the important role that nanotechnology continues to play in the Administration’s innovation agenda.”  The President’s budget supports nanoscale science, engineering, and technology research and development at 11 federal agencies.  Another nine agencies have nanotechnology-related mission interests or regulatory responsibilities.  The supplement documents the progress of these agencies in addressing the goals and objectives of NNI.  According to NNI, over the past year, NNI participating agencies, the White House Office of Science and Technology Policy (OSTP), and the National Nanotechnology Coordination Office (NNCO) “have been charting the future directions of the NNI, including putting greater focus on promoting commercialization and increasing education and outreach efforts to the broader nanotechnology community.”  As part of this effort, NNI has established Nanotechnology-Inspired Grand Challenges, “ambitious but achievable goals that will harness nanotechnology to solve National or global problems and that have the potential to capture the public’s imagination.”  OSTP announced the first Nanotechnology-Inspired Grand Challenge (for future computing) on October 20, 2015.  Topics for additional Nanotechnology-Inspired Grand Challenges are under review.