Switzerland Announces Continuation of Action Plan for Synthetic Nanomaterials

The Federal Office of Public Health (FOPH) announced on December 17, 2014, that the Federal Council decided to continue the action plan for synthetic nanomaterials until 2019.  The objectives of the action plan include:

  • Development of regulatory framework conditions for the responsible handling of synthetic nanomaterials;
  • Creation of scientific and methodical conditions aimed at identifying and preventing potential harmful effects of synthetic nanomaterials on health and the environment;
  • Promotion of the public dialogue about opportunities and risks of nanotechnology; and
  • Better utilization of existing tools for the development and rollout of sustainable nanotechnology applications.

FOPH states that the creation of regulatory framework conditions is divided into two phases.  Phase 1 (short- and medium-term) calls for strengthening corporate responsibility through different tools (precautionary matrix, guide to self-regulation, support of private-sector codes of conduct, guidelines for nano-specific SDSs, improved consumer information, and disposal guide).  Phase 2 (medium- and long-term) calls for the development of legal framework conditions for the safe handling of synthetic nanomaterials (review of measures exceeding existing provisions and coordination with developments abroad). 

Canada's New Substances Program Publishes Risk Assessment Summary for Multi-Wall Carbon Nanotubes

Canada announced on January 9, 2015, that the New Substances Program has published six new risk assessment summaries for chemicals and polymers, including a summary for multi-wall carbon nanotubes.  Environment Canada and Health Canada conduct risk assessments on new substances.  These assessments include consideration of information on physical and chemical properties, hazards, uses, and exposure to determine whether a substance is or may become harmful to human health or environment as set out in Section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), and, if harm is suspected, to introduce any appropriate or required control measures.  The risk assessment conclusion for multi-wall carbon nanotubes states:

When used as notified, the substance is not suspected to be harmful to human health or the environment according to the criteria under section 64 of CEPA 1999.  However it is suspected that a significant new activity in relation to the substance may result in the substance meeting those criteria.

Due to the potential risk to the environment (related to aquatic, soil, and sediment toxicity) and due to the potential risk to the general population (related to respiratory toxicity, immunotoxicity, cardiovascular toxicity and carcinogenicity following oral and inhalation exposure) if the substance is used in increased amounts or in consumer products, a SNAc notice was issued to obtain information to ensure that the substance, in relation to these potential activities, undergoes further assessment.  SNAc notice No. 17192 was published in the Canada Gazette Part I, Vol. 147, No. 34 - August 24, 2013.

A conclusion under CEPA 1999, on this substance, is not relevant to, nor does it preclude, an assessment against the hazard criteria for WHMIS that are specified in the Controlled Products Regulations for products intended for workplace use.

SCENIHR Publishes Final Opinion on Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices

 On January 13, 2015, the European Commission (EC) and its Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) published the final opinion “Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices.”  According to the EC, the Guidance provides information on how to evaluate the risk when a nanomaterial is used in a medical device.  The EC states that the Guidance addresses the use of nanomaterials in medical devices regarding specific aspects that need to be considered in the safety evaluation of nanomaterials and it should be considered in conjunction with the International Organization for Standardization (ISO) 10993-1:2009 standard “Biological evaluation of medical devices.”  The SCENIHR Guidance highlights the need for special considerations in relation to the safety evaluation of nanomaterials, in view of the possible distinct properties, interactions, and effects that may differ from conventional forms of the same materials.  SCENIHR recommends a phased approach based on potential release and characteristics of the nanomaterials.

UK Health and Safety Laboratory Will Hold Course on Nanotechnology Health and Safety

 On January 27, 2015, the United Kingdom (UK) Health and Safety Laboratory (HSL) will hold a one-day course on “Nanotechnology Health & Safety -- A Practical Approach.”  The course is intended to help participants gain an understanding of the techniques and methods available to identify and control exposure to airborne nanomaterials.  HSL states that the course will include:

  • Practical advice and tools on the measures that may be needed to control adequately exposure to airborne nanoparticles during their manufacturing, or during the use and disposal of these materials;
  • Current best practice with references to the new Health and Safety Executive (HSE) and the UK NanoSafety Group guidance “Working Safely with Nanomaterials in Research and Development”;
  • Formal presentations and case studies with opportunities to discuss these issues with experienced HSL scientists; and
  • Hands-on practical training on assessing and implementing control measures and exposure monitoring that allows theory to be put into practice.

The course is aimed at health and safety advisors, occupational hygienists, and users of nanomaterials in universities, research organizations, and industry.

NNCO Will Hold Series of Webinars in 2015

The National Nanotechnology Coordination Office (NNCO), on behalf of the Nanoscale Science, Engineering, and Technology Subcommittee of the Committee on Technology, National Science, and Technology Council, will hold a series of webinars in 2015 focusing on the experiences, successes, and challenges for small- and medium-sized enterprises (SME) working in nanotechnology and on issues of interest to the business community. The first webinar, which will address “What are the biggest issues facing SMEs in the nanotechnology space today?,” will be held January 15, 2015. Questions of interest to the SME community may be submitted to webinar@nnco.nano.gov beginning January 8, 2015. A moderator will identify relevant questions and pose them to the panelists. Registration for the webinar is required and is on a first-come, first-served basis. Registration will open approximately two weeks prior to each event and will be capped at 200 participants.

EPA Withdraws Direct Final SNUR for Functionalized Carbon Nanotubes (Generic)

According to a Federal Register notice scheduled for publication on December 23, 2014, the U.S. Environmental Protection Agency (EPA) is withdrawing several direct final significant new use rules (SNUR) promulgated on October 27, 2014, including one for functionalized carbon nanotubes (generic) (PMN No. P-13-793). EPA states that it received notice of intent to submit adverse comments on the direct final SNURs. EPA intends to publish proposed SNURs for the chemical substances in the notice.

CFS Files Suit to Compel EPA to Respond to 2008 Petition

 The Center for Food Safety (CFS) filed suit on December 16, 2014, in the U.S. District Court for the District of Columbia against the U.S. Environmental Protection Agency (EPA) over its failure to regulate novel nanomaterial pesticides.  CFS states in its press release that in 2008, it filed a legal petition requesting that EPA regulate nanosilver products as pesticides.  EPA opened a public comment period on November 19, 2008, in response to the petition, but according to CFS, “nearly six years later the agency has still failed to respond to Plaintiffs’ 2008 Petition, a failure that violates the mandates of the Administrative Procedure Act (APA).”  The petition states that since the 2008 petition was filed, “hundreds of new pesticidal nano-silver products have reached the market without any pesticide oversight from EPA.”  CFS asks the court to order EPA to respond to its petition “without further unlawful delay.”  The plaintiffs represented by CFS legal counsel in the lawsuit are CFS, its sister non-profit, the International Center for Technology Assessment, as well as Beyond Pesticides, the Center for Environmental Health, Clean Production Action, and the Institute for Agriculture and Trade Policy.

EU Requirement to List Engineered Nanomaterials in Food Labeling Will Take Effect December 13

The European Commission (EC) issued a December 11, 2014, press release concerning European Union (EU) food labeling requirements that will take effect December 13, 2014.  The European Parliament and the Council adopted the requirements in 2011.  The requirements are intended to ensure that consumers receive clearer, more comprehensive, and accurate information on food content, and help them make informed choices about what they eat.  Under the requirements, all ingredients present in the form of engineered nanomaterials must be clearly indicated in the list of ingredients.  The names of such ingredients must be followed by the word “nano” in brackets.  According to the EC, food business operators have had three years “to ensure a smooth transition towards the new labelling regime for prepacked and non-prepacked foods.”  In addition, the regulation “provides for exhaustion of stocks for foods placed on the market or labelled before 13 December 2014.”  The EC states that work is underway to develop an EU database to facilitate the identification of all EU and national mandatory labeling rules in a simple way.  The work for the creation of the database should be carried out during 2015.

EU-U.S. Joint NanoEHS Workshop Will Be Held in March 2015 in Italy

 The National Nanotechnology Coordination Office (NNCO) announced on December 5, 2014, that, in collaboration with the European Commission (EC), it will hold the 2015EU-U.S.:  Bridging NanoEHS Research Efforts” joint workshop on March 12-13, 2015, in Venice, Italy.  According to NNCO, the workshop will bring together the U.S.-European Union (EU) Communities of Research (COR), which serve as a platform for U.S. and EU scientists to share information on nano environmental health and safety (EHS) research.  NNCO states that this workshop, the fourth since 2011, is intended to develop further and support the CORs’ activities.  The six CORs are:

  • Exposure through the Life Cycle, with Material Characterization;

  • Ecotoxicity Testing and Predictive Models, with Material Characterization;

  • Predictive Modeling for Human Health, with Material Characterization;

  • Databases and Ontologies;

  • Risk Assessment; and

  • Risk Management and Control.

Due to space limitations, pre-registration for the workshop is required.  Registration is on a first-come, first-served basis and will be capped at approximately 100 participants.  Registration is now open.

EPA Fall 2014 Regulatory Agenda Includes Item Concerning TSCA Section 8(a) Rule for Nanoscale Materials

The U.S. Environmental Protection Agency’s (EPA) Fall 2014 Regulatory Agenda, which was posted on the Office of Management and Budget’s (OMB) website on November 21, 2014, includes an item concerning Section 8(a) Toxic Substances Control Act (TSCA) reporting and recordkeeping requirements for chemical substances when manufactured or processed as nanoscale materials.  According to the item, the proposed rule would require that persons who manufacture these nanoscale materials notify EPA of certain information, including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data.  EPA states that the proposed reporting of these activities will provide it “with an opportunity to evaluate the information and consider appropriate action under TSCA to reduce any risk to human health or the environment.”  The item states that EPA intends to publish a notice of proposed rulemaking in January 2015.  As reported previously, on October 6, 2014, EPA submitted a proposed rule to OMB, where it currently remains under review.