EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed Publishes 2014 Annual Report

 On February 16, 2015, the European Food Safety Authority (EFSA) published the 2014 annual report of the EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed, which is intended to inform the public and the EFSA Advisory Forum about the Network’s specific activities and achievements.  EFSA states that, during 2014, the Network followed-up on its priority areas and contributed to making inventories of applications of nanomaterials already present in the food/feed chain.  According to EFSA, during its 2014 meeting, the Network dedicated most of its discussions to relevant research results for possible toxic effects following the oral route of exposure.  EFSA’s summary states that a “new issue of concern is that absorption is not linear with dose:  high dose studies are often used for tox testing for estimation of safe dose, while the high dose may result in aggregation, agglomeration, gelation and as a consequence dose-dependent absorption.”  According to the summary, challenges also remain concerning the technical aspects for considering a material as a nanomaterial for the regulatory purpose of food labeling.  The summary states that the NanoDefine project (FP7) is expected to deliver by 2017 an implementable test-scheme for regulatory purposes to distinguish nano from non-nano.  Finally, EFSA states, “[t]he Network agreed that regardless the current challenges and regardless the % of nanoforms in the bulk material (particle size% or mass%), EFSA should assess the nano-fraction, no matter how small.”

ACGIH® TLV®-CS Committee Studying Nanoscale Primary Particle Notation

On January 30, 2015, the American Conference of Governmental Industrial Hygienists (ACGIH®) announced the under study list for its Threshold Limit Values for Chemical Substances (TLV®-CS) Committee.  The under study list includes, under other issues under study, “nanoscale primary particle notation.”  According to ACGIH®, the under study list serves as “notification and invitation to interested parties to submit substantive data and comments to assist the committees in their deliberations.”  The TLV®-CS Committee will consider only those comments and data that address issues of health and exposure, but not economic or technical feasibility.  ACGIH® states that comments must be accompanied by copies of substantiating data, preferably in the form of peer-reviewed literature.  By July 31, 2015, ACGIH® will update the TLV®-CS Committee’s under study list into a two-tier list:

  • Tier 1 consists of chemical substances and physical agents that may move forward as a notice of intent to change (NIC) or notice of intent to establish (NIE) in 2016, based on their status in the development process; and
  • Tier 2 consists of chemical substances and physical agents that will not move forward, but will either remain on, or be removed from, the under study list in 2016.

ACGIH® states that the best time to submit comments is in the early stages of the TLV® development process, preferably while the substance or agent is on the under study list.

CPSC's FY 2016 Budget Request Would Create Center for Consumer Product Applications and Safety Implications of Nanotechnology

 The Consumer Product Safety Commission’s (CPSC) fiscal year (FY) 2016 budget request includes funding to establish a Center for Consumer Product Applications and Safety Implications of Nanotechnology (CPASION), which is intended “to develop robust methods in identifying and characterizing nanomaterials in consumer products; to understand their effects on human exposure; and to develop scientists to advance nanomaterials in consumer product safety research.”  CPSC recommends a $5 million increase in its existing nanotechnology budget, currently $2 million annually, to establish CPASION.  The budget request states that CPASION “will be a consortium of scientists focused on supporting the CPSC’s unique mission through research directed at developing robust methods to quantify and characterize the presence, release, and mechanisms of consumer exposure to nanomaterials from consumer products.”  CPASION will also be a resource for manufacturers and distributors of nano-enabled products, and will develop approaches to providing information on the safe use of nanotechnology in consumer products.  According to the budget request, to establish CPASION, CPSC would enter into a five-year interagency agreement with the National Science Foundation (NSF), modeled on a similarly sized, existing NSF-U.S. Environmental Protection Agency research center studying nanotechnology implications.

EPA Promulgates SNUR for Polymer of Terephthalic Acid and Ethyl Benzene with Multi-Walled Carbon Nanotube (Generic)

On February 2, 2015, the U.S. Environmental Protection Agency (EPA) promulgated through a direct final rule significant new use rules (SNURs) for 27 chemical substances that were the subject of premanufacture notices (PMNs).  The substances include polymer of terephthalic acid and ethyl benzene with multi-walled carbon nanotube (generic) (PMN Number P-13-573), which is subject to a Toxic Substances Control Act (TSCA) Section 5(e) consent order.  The consent order requires the following measures:

  1. Use of personal protective equipment involving impervious gloves and protective clothing (where there is a potential for dermal exposure) and a National Institute for Occupational Safety and Health (NIOSH)-certified respirator with N-100, P-100, or R-100 cartridges (where there is a potential for inhalation exposure);
  2. Submission of certain physical-chemical data for the PMN substance within nine months of signing of the consent order;
  3. Submission of certain human health testing prior to exceeding the confidential production volume limit specified in the consent order;
  4. Processing and use of the PMN substance only for the confidential use specified in the consent order; and
  5. No use of the substance resulting in releases to surface waters.

The SNUR designates as a “significant new use” the absence of these protective measures.  The SNURs require persons who intend to manufacture (including import) or process any of these 27 chemical substances for an activity that is designated as a significant new use by the rule to notify EPA at least 90 days before commencing that activity.  The SNURs are effective on April 3, 2015

Canada Begins Review of SNAc Orders and Notices for Nanomaterials

On January 28, 2015, Environment Canada announced that, with Health Canada, it has initiated a review of significant new activity (SNAc) orders and notices currently in place under the Canadian Environmental Protection Act (CEPA).  According to Environment Canada, since publication of the first SNAc in 2001, policies and practices have evolved, particularly with respect to the nature and scope of SNAcs, as well as the wording used to identify “significant new activities.”  The SNAc review is intended to ensure that SNAcs are in step with current information, policies, and approaches.  The SNAc review groups include 33 SNAcs for nanomaterials, published between 2008 and 2013.  The review timeline for the nanomaterials group is 2014-2015.  Environment Canada states that, following the review process, there may be no changes needed for certain SNAcs or, for others, rescissions or amendments may be warranted.  As the review will be implemented via a phased approach, Canada will publish information on the results of the review process on an ongoing basis as elements of the review are completed.  Elements of the review may be subject to external consultation.

NGOs Comment on EC's Working Conclusions Concerning Transparency Measures for Nanomaterials on the Market

The European Environmental Bureau (EEB) posted on January 13, 2015, a paper entitled “NGO comments on Transparency measures for nanomaterials on the market:  Working conclusions.”  EEB, the Center for International Environmental Law (CIEL), Friends of the Earth (FOE) Australia, and Friends of the Earth Germany (BUND) state that they disagree with most of the EC’s working conclusions regarding the transparency measures for nanomaterials on the market.  The NGOs claim that the EC’s conclusions “are biased towards industry’s economic interests whilst disregarding environmental health and safety concerns and the public right to know.  We believe the working conclusions fail to provide the right balance between private and public interests.”  The NGOs state:  “In light of the early warnings and key data gaps regarding the risks associated with nanomaterials compilation of necessary information and transparency measures should be driven by the precautionary principle.  This is the only way to adequately manage the potential risks associated with nanomaterials.”

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.