Tag Archives: European Chemicals Agency (ECHA)

Nanomaterials are now nanoforms?

Leave a reply

There’s a proposal/recommendation/call to start calling nanomaterials ‘nanoforms’ according to an April 20, 2021 article (you can also find it here on JDSupra) by Lynn Bergeson and Carla N. Hutton in April 27, 2021 (Volume XI, Number 117) issue of the National Law Review,

The Nanotechnology Industries Association (NIA) has published a March 2021 position paper, A changing regulatory landscape and language for the nanoscale, that examines the transition from “nanomaterial” to “nanoforms” to reflect better the differences in nanomaterial properties both in relation to bulk counterparts and to nanoforms of the same substance.  In the paper, NIA describes a transition phase where the language of nanoforms is used more widely and examples of nanoform sets can be increasingly demonstrated in the public domain, while there is still a “significant” learning curve for both industry and the European Chemicals Agency (ECHA).  NIA recommends that all stakeholders reassess the language they use where relevant, “particularly when discussing hazard, and where non-specific terminology may be misleading and result in confusion and mistrust in the safety of substances at the nanoscale.” …

I haven’t noticed the use of nanoforms yet but, going forward, I will be alert to the change in terminology.

Searchable database for hazardous nanomaterials and a Graphene Verification Programme

Leave a reply

I have two relatively recent news bits about nanomaterials, the second being entirely focused on graphene.

Searchable database

A July 9, 2019 news item on Nanowerk announces a means of finding out what hazards may be associated with 300 different nanomaterials (Note: A Link has been removed),

A new search tool for nanomaterials has been published on the European Union Observatory for Nanomaterials (EUON) website. It will enable regulators to form a better view of available data and give consumers access to chemicals safety information.

The tool combines data submitted by companies in their REACH registrations [Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) ], data collected about nanomaterials used as ingredients in cosmetic products under the Cosmetics Regulation and data from the public national nanomaterial inventories of Belgium and France.

…

A July 3, 2019 EUON press release, which originated the news item, provides a bit more detail,

The EUON’s search brings data from these sources together in one place, allowing users to easily search for nanomaterials that are currently on the EU market. The results are linked to ECHA’s [European Chemicals Agency] database of chemicals registered in the EU and, for the first time, summarised information about the substances, their properties as well as detailed safety and characterisation data can be easily found.

Background

While there are over 300 nanomaterials on the EU market, 37 are currently covered by an existing registration under REACH. The information requirements for REACH were revised last year with explicit obligations for nanomaterials manufactured in or imported to the EU. The new requirements enter into force in January 2020 and will result in more publicly available information.

The EUON aims to increase the transparency of information available to the public on the safety and markets of nanomaterials in the EU. A key aim of the observatory is to create a one-stop shop for information, where EU citizens and stakeholders including NGOs, industry, and regulators can all easily find accessible and relevant safety information on nanomaterials on the EU market.

Here’s the searchable database.

Graphene verification

There was a bit of a scandal about fake graphene in the Fall of 2018 (my May 28, 2019 posting gives details). Dexter Johnson provides additional insight and information about the launch of a new graphene verification programme and news of a slightly older graphene verification programme in his July 9, 2019 article for the Nanoclast blog on the IEEE (Institute of Electrical and Electronics Engineers) website (Note: Links have been removed),

Last year [2018], the graphene community was rocked by a series of critical articles that appeared in some high-profile journals. First there was an Advanced Material’s article with the rather innocuously title: “The Worldwide Graphene Flake Production”. It was perhaps the follow-up article that appeared in the journal Nature that really shook things up with its incendiary title: “The war on fake graphene”.

In these two articles it was revealed that material that had been claimed to be high-quality (and high-priced) graphene was little more than graphite powder. Boosted by their appearance in high-impact journals, these articles threatened the foundations of the graphene marketplace.

But while these articles triggered a lot of hand wringing among the buyers and sellers of graphene, it’s not clear that their impact extended much beyond the supply chain of graphene. Whether or not graphene has aggregated back to being graphite is one question. An even bigger one is whether or not consumers are actually being sold a better product on the basis that it incorporates graphene.

…

Dexter details some of the issues from the consumer’s perspective (Note: Links have been removed),

Consumer products featuring graphene today include everything from headphones to light bulbs. Consequently, there is already confusion among buyers about the tangible benefits graphene is supposed to provide. And of course the situation becomes even worse if the graphene sold to make products may not even be graphene: how are consumers supposed to determine whether graphene infuses their products with anything other than a buzzword?

Another source of confusion arises because when graphene is incorporated into a product it is effectively a different animal from graphene in isolation. There is ample scientific evidence that graphene when included in a material matrix, like a polymer or even paper, can impart new properties to the materials. “You can transfer some very useful properties of graphene into other materials by adding graphene, but just because the resultant material contains graphene it does not mean it will behave like free-standing graphene, explains Tom Eldridge, of UK-based Fullerex, a consultancy that provides companies with information on how to include graphene in a material matrix

…

The rest of Dexter’s posting goes on to mention two new graphene verification progammes (producer and product) available through The Graphene Council. As for what the council is, there’s this from council’s About webpage,

…

The Graphene Council was founded in 2013 with a mission to serve the global community of graphene professionals. Today, The Graphene Council is the largest community in the world for graphene researchers, academics, producers, developers, investors, nanotechnologists, regulatory agencies, research institutes, material science specialists and even the general public. We reach more than 50,000 people with an interest in this amazing material. 

…

Interestingly the council’s offices are located in the US state of North Carolina. (I would have guessed that its headquarters would be in the UK, given the ‘ownership’ the UK has been attempting to establish over graphene Let me clarify, by ownership I mean the Brits want to be recognized as dominant or preeminent in graphene research and commercialization.)

The council’s first verified graphene producer is a company based in the UK as can be seen in an April 1, 2019 posting by council director Terrance Barkan on the council’s blog,

The Graphene Council is pleased to announce that Versarien plc is the first graphene company in the world to successfully complete the Verified Graphene Producer™ program, an independent, third party verification system that involves a physical inspection of the production facilities, a review of the entire production process, a random sample of product material and rigorous characterization and testing by a first class, international materials laboratory.

The Verified Graphene Producer™ program is an important step to bring transparency and clarity to a rapidly changing and opaque market for graphene materials, providing graphene customers with a level of confidence that has not existed before.

“We are pleased to have worked with the National Physical Laboratory (NPL) in the UK, regarded as one of the absolute top facilities for metrology and graphene characterization in the world.
 
They have provided outstanding analytical expertise for the materials testing portion of the program including Raman Spectroscopy, XPS, AFM and SEM testing services.” stated Terrance Barkan CAE, Executive Director of The Graphene Council.
 
Andrew Pollard, Science Area Leader of the Surface Technology Group, National Physical Laboratory, said: “In order to develop real-world products that can benefit from the ‘wonder material’, graphene, we first need to fully understand its properties, reliably and reproducibly.
 
“Whilst international measurement standards are currently being developed, it is critical that material characterisation is performed to the highest possible level.
 
As the UK’s National Measurement Institute (NMI) with a focus on developing the metrology of graphene and related 2D materials, we aim to be an independent third party in the testing of graphene material for companies and associations around the world, such as The Graphene Council.” 
 
Neill Ricketts, CEO of Versarien said: “We are delighted that Versarien is the first graphene producer in the world to successfully complete the Graphene Council’s Verified Graphene Producer™ programme.”
 
“This is a huge validation of our technology and will enable our partners and potential customers to have confidence that the graphene we produce meets globally accepted standards.”
 
“There are many companies that claim to be graphene producers, but to enjoy the benefits that this material can deliver requires high quality, consistent product to be supplied.  The Verified Producer programme is designed to verify that our production facilities, processes and tested material meet the stringent requirements laid down by The Graphene Council.”

“I am proud that Versarien has been independently acclaimed as a Verified Graphene Producer™ and look forward to making further progress with our collaboration partners and numerous other parties that we are in discussions with.”

James Baker CEng FIET, the CEO of Graphene@Manchester (which includes coordinating the efforts of the National Graphene Institute and the Graphene Engineering and Innovation Centre [GEIC]) stated: “We applaud The Graphene Council for promoting independent third party verification for graphene producers that is supported by world class metrology and characterization services.”

“This is an important contribution to the commercialization of graphene as an industrial material and are proud to have The Graphene Council as an Affiliate Member of the Graphene Engineering and Innovation Centre (GEIC) here in Manchester ”.

Successful commercialization of graphene materials requires not only the ability to produce graphene to a declared specification but to be able to do so at a commercial scale.
It is nearly impossible for a graphene customer to verify the type of material they are receiving without going through an expensive and time consuming process of having sample materials fully characterized by a laboratory that has the equipment and expertise to test graphene.

The Verified Graphene Producer™ program developed by The Graphene Councilprovides a level of independent inspection and verification that is not available anywhere else.

…

As for the “Verified Graphene Product” programme mentioned in Dexter’s article (it’s not included in the excerpts here), I can’t find any sign of it ion the council’s website.

OECD (Organization for Economic Cooperation and Development) Dossiers on Nanomaterials Are of “Little to No Value for assessing risk?”

Leave a reply

The announcement that a significant portion of the OECD’s (Organization for Economic Cooperation and Development) dossiers on 11 nanomaterials have next to no value for assessing risk seems a harsh judgment from the Center for International Environmental Law (CIEL). From a March 1, 2017 posting by Lynn L. Bergeson on the Nanotechnology Now,

On February 23, 2017, the Center for International Environmental Law (CIEL) issued a press release announcing a new report, commissioned by CIEL, the European Environmental Citizens’ Organization for Standardization (ECOS), and the Oeko-Institute, that “shows that most of the information made available by the Sponsorship Testing Programme of the Organisation for Economic Co-operation and Development (OECD) is of little to no value for the regulatory risk assessment of nanomaterials.”

Here’s more from the Feb. 23, 3017 CIEL press release, which originated the posting,

The study published today [Feb. 23, 2017] was delivered by the Institute of Occupational Medicine (IOM) based in Singapore. IOM screened the 11,500 pages of raw data of the OECD dossiers on 11 nanomaterials, and analysed all characterisation and toxicity data on three specific nanomaterials – fullerenes, single-walled carbon nanotubes, and zinc oxide.

“EU policy makers and industry are using the existence of the data to dispel concerns about the potential health and environmental risks of manufactured nanomaterials,” said David Azoulay, Senior Attorney for CIEL. “When you analyse the data, in most cases, it is impossible to assess what material was actually tested. The fact that data exists about a nanomaterial does not mean that the information is reliable to assess the hazards or risks of the material.”

The dossiers were published in 2015 by the OECD’s Working Party on Manufactured Nanomaterials (WPMN), which has yet to draw conclusions on the data quality. Despite this missing analysis, some stakeholders participating in EU policy-making – notably the European Chemicals Agency (ECHA) and the European Commission’s Joint Research Centre – have presented the dossiers as containing information on nano-specific human health and environmental impacts. Industry federations and individual companies have taken this a step further emphasizing that there is enough information available to discard most concerns about potential health or environmental risks of manufactured nanomaterials.

“Our study shows these claims that there is sufficient data available on nanomaterials are not only false, but dangerously so,” said Doreen Fedrigo, Senior Policy Officer of ECOS. ”The lack of nano-specific information in the dossiers means that the results of the tests cannot be used as evidence of no ‘nano-effect’ of the tested material. This information is crucial for regulators and producers who need to know the hazard profile of these materials. Analysing the dossiers has shown that legislation detailing nano-specific information requirements is crucial for the regulatory risk assessment of nanomaterials.”

The report provides important recommendations on future steps in the governance of nanomaterials. “Based on our analysis, serious gaps in current dossiers must be filled in with characterisation information, preparation protocols, and exposure data,” said Andreas Hermann of the Oeko-Institute. “Using these dossiers as they are and ignoring these recommendations would mean making decisions on the safety of nanomaterials based on faulty and incomplete data. Our health and environment requires more from producers and regulators.”

CIEL has an Analysis of OECD WPMN Dossiers Regarding the Availability of Data to Evaluate and Regulate Risk (Dec 2016) webpage which provides more information about the dossiers and about the research into the dossiers and includes links to the report, the executive summer, and the dataset,

The Sponsorship Testing Programme of the Working Party on Manufactured Nanomaterials (WPMN) of the Organisation for Economic Co-operation and Development (OECD) started in 2007 with the aim to test a selection of 13 representative nanomaterials for many endpoints. The main objectives of the programme were to better understand what information on intrinsic properties of the nanomaterials might be relevant for exposure and hazards assessment and assess the validity of OECD chemicals Test Guidelines for nanomaterials. The testing programme concluded in 2015 with the publication of dossiers on 11 nanomaterials: 11,500 pages of raw data to be analysed and interpreted.

The WPMN has not drawn conclusions on the data quality, but some stakeholders participating in EU policy-making – notably the European Chemicals Agency and the European Commission’s Joint Research Centre – presented the dossiers as containing much scientific information that provided a better understanding of their nano-specific human health and environmental impacts. Industry federations and individual companies echoed the views, highlighting that there was enough information available to discard most concerns about potential health or environmental risks of manufactured nanomaterials.

As for the OECD, it concluded, even before the publication of the dossiers, that “many of the existing guidelines are also suitable for the safety assessment of nanomaterials” and “the outcomes (of the sponsorship programme) will provide useful information on the ‘intrinsic properties’ of nanomaterials.”

The Center for International Environmental Law (CIEL), the European Citizens’ Organisation for Standardisation (ECOS) and the Öko-Institut commissioned scientific analysis of these dossiers to assess the relevance of the data for regulatory risk assessment.

The resulting report: Analysis of OECD WPMN dossiers regarding the availability of data to evaluate and regulate risk, provides insights illustratating how most of the information made available by the sponsorship programme is of little to no value in identifying hazards or in assessing risks due to nanomaterials.

The analysis shows that:

  • Most studies and documents in the dossiers contain insufficient characterisation data about the specific nanomaterial addressed (size, particle distribution, surface shape, etc.), making it impossible to assess what material was actually tested.
  • This makes it impossible to make any firm statements regarding the nano-specificity of the hazard data published, or the relationship between observed effects and specific nano-scale properties.
  • Less than 2% of the study records provide detail on the size of the nanomaterial tested. Most studies use mass rather than number or size distribution (so not following scientifically recommended reporting practice).
  • The absence of details on the method used to prepare the nanomaterial makes it virtually impossible to correlate an identified hazard with specific nanomaterial characteristic. Since the studies do not indicate dispersion protocols used, it is impossible to assess whether the final dispersion contained the intended mass concentration (or even the actual presence of nanomaterials in the test system), how much agglomeration may have occurred, and how the preparation protocols may have influenced the size distribution.
  • There is not enough nano-specific information in the dossiers to inform about nano-characteristics of the raw material that influence their toxicology. This information is important for regulators and its absence makes information in the dossier irrelevant to develop read-across guidelines.
  • Only about half of the endpoint study records using OECD Test Guideliness (TGs) were delivered using unaltered OECD TGs, thereby respecting the Guidelines’ requirements. The reasons for modifications of the TGs used in the tests are not clear from the documentation. This includes whether the study record was modified to account for challenges related to specific nanomaterial properties or for other, non-nano-specific reasons.
  • The studies do not contain systematic testing of the influence of nano-specific characteristics on the study outcome, and they do not provide the data needed to assess the effect of nano-scale features on the Test Guidelines. Given the absence of fundamental information on nanomaterial characteristics, the dossiers do not provide evidence of the applicability of existing OECD Test Guidelines to nanomaterials.

The analysis therefore dispels several myths created by some stakeholders following publication of the dossiers and provides important perspective for the governance of nanomaterials. In particular, the analysis makes recommendations to:

  • Systematically assess the validity of existing Test Guidelines for relevance to nanomaterials
  • Develop Test Guidelines for dispersion and other test preparations
  • Define the minimum characteristics of nanomaterials that need to be reported
  • Support the build-up of exposure database
  • Fill the gaps in current dossiers with characterisation information, preparation protocols and exposure data

Read full report.
Read executive summary.
Download full dataset.

This is not my area of expertise and while I find the language a bit inflammatory, it’s my understanding that there are great gaps in our understanding of nanomaterials and testing for risk assessment has been criticized for many of the reasons pointed out by CIEL, ECOS, and the Oeko-Institute.

You can find out more about CIEL here; ECOS here; and the Oeko-Institute (also known as Öko-Institute) here.

US Environmental Protection Agency finalizes its one-time reporting requirements for nanomaterials

Leave a reply

The US Environmental Protection Agency (EPA) has announced its one-time reporting requirement for  nanomaterials. From a Jan. 12, 2017 news item on Nanowerk,

The U.S. Environmental Protection Agency (EPA) is requiring one-time reporting and recordkeeping requirements on nanoscale chemical substances in the marketplace. These substances are nano-sized versions of chemicals that are already in the marketplace.
EPA seeks to facilitate innovation while ensuring safety of the substances. EPA currently reviews new chemical substances manufactured or processed as nanomaterials prior to introduction into the marketplace to ensure that they are safe.

For the first time, EPA is using [the] TSCA [Toxic Substances Control Act] to collect existing exposure and health and safety information on chemicals currently in the marketplace when manufactured or processed as nanoscale materials.

The companies will notify EPA of certain information:
– specific chemical identity;
– production volume;
– methods of manufacture; processing, use, exposure, and release information; and,available health and safety data.

Reactions

David Stegon writes about the requirement in a Jan. 12, 2017 posting on Chemical Watch,

The US EPA has finalised its nanoscale materials reporting rule, completing a process that began more than 11 years ago.

…

The US position contrasts with that of the European Commission, which has rejected the idea of a specific mandatory reporting obligation for nanomaterials. Instead it insists such data can be collected under REACH’s registration rules for substances in general. It has told Echa [ECHA {European Chemicals Agency}] to develop ‘nano observatory’ pages on its website with existing nanomaterial information. Meanwhile, Canada set its reporting requirements in 2015.

The US rule, which comes under section 8(a) of TSCA, will take effect 120 days after publication in the Federal Register.

It defines nanomaterials as chemical substances that are:

  • solids at 25 degrees Celsius at standard atmospheric pressure;
  • manufactured or processed in a form where any particles, including aggregates and agglomerates, are between 1 and 100 nanometers (nm) in at least one dimension; and
  • manufactured or processed to exhibit one or more unique and novel property.

The rule does not apply to chemical substances manufactured or processed in forms that contain less than 1% by weight of any particles between 1 and 100nm.

Taking account of comments received on the rulemaking, the EPA made three changes to the proposed definition:

  • it added the definition of unique and novel properties to help identify substances that act differently at nano sizes;
  • it clarified that a substance is not a nanomaterial if it fits the specified size range, but does not have a size-dependent property that differs from the same chemical at sizes greater than 100nm; and
  • it eliminated part of the nanomaterial definition that had said a reportable chemical may not include a substance that only has trace amounts of primary particles, aggregates, or agglomerates in the size range of 1 to 100nm.

…

The EPA has added the new information gathering rule (scroll down about 50% of the way) on its Control of Nanoscale Materials under the Toxic Substances Control Act webpage.

There’s also this Jan. 17, 2017 article by Meagan Parrish for the ChemInfo which provides an alternative perspective and includes what appears to be some misinformation (Note: A link has been removed),

It was several years in the making, but in the final stages of its rule-making process for nanomaterial reporting, the Environmental Protection Agency declined to consider feedback from the industry.

Now, with the final language published and the rule set to go into effect in May, some in the industry are concerned that the agency is requiring an unnecessary amount of costly reporting that isn’t likely to reveal potential hazards. The heightened regulations could also hamper the pace of innovation underway in the industry.

…

“The poster child for nanotechnology is carbon nanotubes,” says James Votaw, a partner with Manatt, Phelps & Phillips, of the form of carbon that is 10,000 smaller than human hair but stronger than steel. “It can be used to make very strong materials and as an additive in plastics to make them electrically conductive or stiffer.”

The EPA has been attempting to define nanomaterials since 2004 and assess the potential for environmental or human health risks associated with their use. In 2008, the EPA launched an effort to collect voluntarily submitted information from key players in the industry, but after a few years, the agency wasn’t happy with amount of responses. The effort to create a mandatory reporting requirement was launched in 2010.

Yet, according to Votaw, after a 2015 proposal of the rule was extensively criticized by the industry for being overly ambiguous and overly inclusive of its coverage, the industry asked the EPA to reopen a dialogue on the rule. The EPA declined.

…

The new reporting requirement is expected to cost companies about $27.79 million during the first year and $3.09 million in subsequent years. [emphasis mine]

As far as I’m aware, this is a one-time reporting requirement. Although I’m sure many would like to see that change.

As for the Canadian situation, I mentioned the nanomaterials mandatory survey noted in Stegon’s piece in a July 29, 2015 posting. It was one of a series of mandatory surveys (currently, a survey on asbestos is underway) issued as part of Canada’s Chemicals Management Plan. You can find more information about the nanomaterials notice and approach to the survey although there doesn’t appear to have been a report made public but perhaps it’s too soon. From the Nanomaterials Mandatory Survey page,

The Government of Canada is undertaking a stepwise approach to address nanoscale forms of substances on the DSL. The proposed approach consists of three phases:

  • Establishment of a list of existing nanomaterials in Canada (this includes the section 71 Notice);
  • Prioritization of existing nanomaterials for action; and
  • Action on substances identified for further work.

The overall approach was first described in a consultation document entitled Proposed Approach to Address Nanoscale Forms of Substances on the Domestic Substances List, published on March 18, 2015. This consultation document was open for a 60-day public comment period to solicit feedback from stakeholders, particularly on the first phase of the approach.

A second consultation document entitled Proposed Prioritization Approach for Nanoscale Forms of Substances on the Domestic Substances List was published on July 27, 2016. In this document, the approach proposed for prioritization of existing nanomaterials on the DSL is described, taking into consideration the results of the section 71 Notice.  Comments on this consultation document may be submitted prior to September 25, 2016 …

I look forward to discovering a report on the Canadian nanomaterials survey should one be made public.

The Canadian nano scene as seen by the OECD (Organization for Economic Cooperation and Development)

Leave a reply

I’ve grumbled more than once or twice about the seemingly secret society that is Canada’s nanotechnology effort (especially health, safety, and environment issues) and the fact that I get most my information from Organization for Economic Cooperation and Development (OECD) documents. That said, thank you to Lynne Bergeson’s April 8, 2016 post on Nanotechnology Now for directions to the latest OECD nano document,

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.

It’s an international roundup that includes: 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).

As usual, I’m focusing on Canada. From the DEVELOPMENTS IN DELEGATIONS ON THE SAFETY OF MANUFACTURED NANOMATERIALS – TOUR DE TABLE Series on the Safety of Manufactured Nanomaterials No. 67,

CANADA
National  developments  on  human  health  and  environmental  safety  including  recommendations, definitions, or discussions related to adapting or applying existing regulatory systems or the drafting of new laws/ regulations/amendments/guidance materials A consultation document on a Proposed Approach to Address Nanoscale Forms of Substances on the Domestic  Substances  List was  published  with  a  public  comment  period  ending on  May  17,  2015. The proposed approach outlines the Government’s plan to address nanomaterials considered in commerce in Canada (on  Canada’s  public inventory).  The  proposal is a stepwise  approach to  acquire  and  evaluate information,  followed  by  any  necessary  action. A  follow-up  stakeholder  workshop  is  being  planned  to discuss  next  steps  and  possible  approaches  to prioritize  future  activities. The  consultation document  is available at: http://www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=1D804F45-1

A mandatory information gathering survey was published on July 25, 2015. The purpose of the survey is to collect information to determine the commercialstatus of certain nanomaterials in Canada. The survey targets  206  substances  considered  to  be  potentially  in commerce  at  the  nanoscale. The  list  of  206 substances was developed using outcomes from the Canada-United States Regulatory Cooperation Council (RCC)  Nanotechnology  Initiative  to  identify nanomaterial  types. These  nanomaterial  types  were  cross-referenced  with  the Domestic  Substances  List to  develop  a  preliminary  list  of  substances  which are potentially intentionally manufactured at the nanoscale. The focus of the survey aligns with the Proposed Approach to  Address  Nanoscale  Forms  of  Substances  on  the Domestic  Substances  List (see  above)  and certain  types  of  nanomaterials  were  excluded  during the  development  of  the  list  of  substances. The information  being  requested  by  the  survey  includes substance  identification,  volumes,  and  uses.  This information will feed into the Government’s proposed approach to address nanomaterials on the Domestic Substances List. Available at: http://gazette.gc.ca/rp-pr/p1/2015/2015-07-25/html/notice-avis-eng.php

Information on:

a.risk  assessment  decisions, including  the  type  of:  (a)  nanomaterials  assessed; (b) testing recommended; and (c) outcomes of the assessment;

Four substances were notified to the program since the WPMN14 – three surface modified substances and  one  inorganic  substance.  No  actions,  including  additional  data requests,  were  taken  due  to  low expected  exposures  in  accordance  with  the New  Substances  Notifications  Regulations  (Chemicals and Polymers) (NSNR) for two of the substances.  Two of the substances notified were subject to a Significant New Activity Notice. A Significant New Activity notice is an information gathering tool used to require submission  of  additional  information  if  it  is suspected  that  a  significant  new  activity  may  result in  the substance becoming toxic under the Canadian Environmental Protection Act, 1999.

b.Proposals, or modifications to previous regulatory decisions

As  part  of  the  Government’s  Chemicals  Management Plan,  a  review  is  being  undertaken  for  all substances  which  have  been  controlled through  Significant  New  Activity  (SNAc)  notices (see  above).  As part  of  this  activity,  the  Government  is  reviewing past  nanomaterials  SNAc  notices  to  see  if  new information  is  available  to  refine  the  scope  and information  requirements.    As  a  result  of  this  review, 9 SNAc  notices  previously  in  place  for  nanomaterials have  been  rescinded.    This  work  is  ongoing,  and  a complete review of all nanomaterial SNAcs is currently planned to be completed in 2016.

Information related to good practice documents

The Canada-led,  ISO  standards project, ISO/DTR  19716 Nanotechnologies — Characterization  of cellulose  nanocrystals, [emphasis mine] initiated  in  April 2014, is  now at Committee  Draft  (CD)  3-month  ISO ballot, closing    Aug 31, 2015. Ballot comments will be addressed during JWG2 Measurement and Characterization working  group meetings  at  the 18th Plenary  of  ISO/TC229, Nanotechnologies,  being held in Edmonton, Alberta, Sep. 28 – Oct. 2, 2015.

Research   programmes   or   strategies   designed   to  address   human   health   and/   or environmental safety aspects of nanomaterials

Scientific research

Environment Canada continues to support various academic and departmental research projects. This research has to date included studying fate and effects of nanomaterials in the aquatic, sediment, soil, and air  compartments. Funding  in  fiscal  2015-16  continues  to  support  such  projects,  including  sub-surface transportation, determining key physical-chemical parameters to predict ecotoxicity, and impacts of nano-silver [silver nanoparticles]  addition  to  a  whole  lake  ecosystem [Experimental Lakes Area?]. Environment  Canada  has  also  partnered  with  the National Research  Council  of  Canada  recently  to  initiate  a project  on  the  development  of  test  methods  to identify surfaces of nanomaterials for the purposes of regulatory identification and to support risk assessments. In addition,  Environment  Canada  is  working  with  academic laboratories in  Canada  and  Germany  to  prepare guidance to support testing of nanoparticles using the OECD Test Guideline for soil column leaching.

Health  Canada  continues  its  research  efforts  to  investigate  the  effects  of  surface-modified  silica nanoparticles. The   aims   of   these   projects   are  to:   (1) study the importance of size and surface functionalization;  and  (2)  provide a genotoxic profile and  to  identify  mechanistic  relationships  of  particle properties  to  elicited  toxic  responses.  A manuscript reporting  the in  vitro genotoxic,  cytotoxic and transcriptomic  responses  following  exposure  to  silica  nanoparticles  has  recently  been  submitted to  a  peer reviewed journal and is currently undergoing review. Additional manuscripts reporting the toxicity results obtained to date are in preparation.

Information on public/stakeholder consultations;

A consultation document on a Proposed Approach to Address Nanoscale Forms of Substances on the Domestic  Substances  List was  published  with a  public  comment  period ending  on May  17,  2015  (see Question  1).  Comments  were  received  from approximately  20  stakeholders  representing  industry and industry  associations,  as  well  as  non-governmental  organizations. These  comments  will  inform  decision making to address nanomaterials in commerce in Canada.

Information on research or strategies on life cycle aspects of nanomaterials

Canada, along with Government agencies in the United States, Non-Governmental Organizations and Industry,  is  engaged  in  a  project  to  look  at releases  of  nanomaterials  from  industrial  consumer  matrices (e.g., coatings). The objectives of the NanoRelease Consumer Products project are to develop protocols or
methods (validated  through  interlaboratory  testing) to  measure  releases  of  nanomaterials  from  solid matrices as a result of expected uses along the material life cycle for consumer products that contain the nanomaterials. The  project  is  currently  in  the  advanced  stages  of Phase  3  (Interlaboratory  Studies).  The objectives of Phase 3 of the project are to develop robust methods for producing and collecting samples of CNT-epoxy  and  CNT-rubber  materials  under  abrasion  and  weathering scenarios,  and  to  detect  and quantify, to the extent possible, CNT release fractions. Selected laboratories in the US, Canada, Korea and the European Community are finalising the generation and analysis of sanding and weathering samples and the    results    are    being    collected    in    a   data    hub    for    further    interpretation    and    analysis.

Additional details about the project can be found at the project website: http://www.ilsi.org/ResearchFoundation/RSIA/Pages/NanoRelease1.aspx

Under the OECD Working Party on Resource Productivity and Waste (WPRPW), the expert group on waste containing nanomaterials has developed four reflection papers on the fate of nanomaterials in waste treatment  operations.  Canada  prepared the  paper  on  the  fate  of  nanomaterials in  landfills;  Switzerland on the  recycling  of  waste  containing  nanomaterials;  Germany  on  the  incineration  of  waste  containing nanomaterials;  and  France  on  nanomaterials  in wastewater  treatment.  The  purpose  of  these  papers is to provide  an  overview  of  the  existing  knowledge  on the  behaviour  of  nanomaterials  during  disposal operations and identify the information gaps. At the fourth meeting of the WPRPW that took place on 12-14 November 2013, three of the four reflection papers were considered by members. Canada’s paper was presented and discussed at the fifth meeting of the WPRPRW that took place on 8-10 December 2014. The four  papers  were  declassified  by  EPOC  in  June  2015, and  an  introductory  chapter  was  prepared  to  draw these  papers  together. The introductory  chapter  and accompanying  papers  will  be  published in  Fall  2015. At  the sixth  meeting  of  the  WPRPW  in  June – July  2015,  the  Secretariat  presented  a  proposal  for an information-sharing  platform  that  would  allow  delegates  to  share research  and  documents  related  to nanomaterials. During a trial phase, delegates will be asked to use the platform and provide feedback on its use at the next meeting of the WPRPW in December 2015. This information-sharing platform will also be accessible to delegates of the WPMN.

Information related to exposure measurement and exposure mitigation.

Canada and the Netherlands are co-leading a project on metal impurities in carbon nanotubes. A final version  of  the  report  is  expected  to  be ready for WPMN16. All  research has  been completed (e.g. all components are published or in press and there was a presentation by Pat Rasmussen to SG-08 at the Face-to-Face Meeting in Seoul June 2015). The first draft will be submitted to the SG-08 secretariat in autumn 2015. Revisions  will  be  based  on  early  feedback  from  SG-08  participants.  The  next  steps  depend  on  this feedback and amount of revision required.

Information on past, current or future activities on nanotechnologies that are being done in co-operation with non-OECD countries.

A webinar between ECHA [European Chemicals Agency], the US EPA [Environmental Protection Agency] and Canada was hosted by Canada on April 16, 2015. These are  regularly  scheduled  trilateral  discussions  to keep  each  other  informed  of  activities  in  respective jurisdictions.

In  March 2015, Health  Canada  hosted  3  nanotechnology knowledge  transfer sessions  targeting Canadian  government  research  and  regulatory  communities  working  in  nanotechnology.  These  sessions were  an  opportunity  to  share  information  and perspectives  on  the  current  state  of  science supporting  the regulatory  oversight  of  nanomaterials with  Government.  Presenters  provided  detailed  outputs  from  the OECD WPMN including: updates on OECD test methods and guidance documents; overviews of physical-chemical properties, as well as their relevance to toxicological testing and risk assessment; ecotoxicity and fate   test   methods;   human   health   risk   assessment   and   alternative   testing   strategies;   and exposure measurement  and  mitigation.  Guest  speakers  included  Dr  Richard  C.  Pleus  Managing  Director  and  Director of Intertox, Inc and Dr. Vladimir Murashov Special Assistant on Nanotechnology to the Director of National Institute for Occupational Safety and Health (NIOSH).

On   March   4-5, 2015, Industry   Canada   and   NanoCanada co-sponsored  “Commercializing Nanotechnology  in  Canada”,  a  national  workshop  that brought  together  representatives  from  industry, academia and government to better align Canada’s efforts in nanotechnology.  This workshop was the first of  its  kind  in  Canada. It  also  marked  the  official  launch  of  NanoCanada (http://nanocanada.com/),  a national  initiative  that  is  bringing  together stakeholders  from  across  Canada  to  bridge  the  innovation  gap and stimulates emerging technology solutions.

It’s nice to get an update about what’s going on. Despite the fact this report was published in 2016 the future tense is used in many of the verbs depicting actions long since accomplished. Maybe this was a cut-and-paste job?

Moving on, I note the mention of the Canada-led,  ISO  standards project, ISO/DTR  19716 Nanotechnologies — Characterization  of cellulose  nanocrystals (CNC). For those not familiar with CNC, the Canadian government has invested hugely in this material derived mainly from trees, in Canada. Other countries and jurisdictions have researched nanocellulose derived from carrots, bananas, pineapples, etc.

Finally, it was interesting to find out about the existence of  NanoCanada. In looking up the Contact Us page, I noticed Marie D’Iorio’s name. D’Iorio, as far as I’m aware, is still the Executive Director for Canada’s National Institute of Nanotechnology (NINT) or here (one of the National Research Council of Canada’s institutes). I have tried many times to interview someone from the NINT (Nils Petersen, the first NINT ED and Martha Piper, a member of the advisory board) and more recently D’Iorio herself only to be be met with a resounding silence. However, there’s a new government in place, so I will try again to find out more about the NINT, and, this time, NanoCanada.