Tag Archives: Lynn L. Bergeson

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

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.

Changes to the US 21st Century Nanotechnology Research and Development Act

This is one of Barack Obama’s last acts as President of the US according to a Jan. 5, 2017 posting by Lynn L. Bergeson on the Nanotechnology Now website,

The American Innovation and Competitiveness Act (S. 3084) would amend the 21st Century Nanotechnology Research and Development Act (15 U.S.C. § 7501 et seq.) to change the frequency of National Nanotechnology Initiative (NNI) reports. The strategic plan would be released every five instead of every three years, and the triennial review would be renamed the quadrennial review and be prepared every four years instead of every three. The evaluation of the NNI, which is submitted to Congress, would be due every four instead of every three years. … On December 28, 2016, the bill was presented to President Obama. President Obama is expected to sign the bill.

Congress.gov is hosting the S.3084 – American Innovation and Competitiveness Act webpage listing all of the actions, to date, taken on behalf of this bill; Obama signed the act on Jan. 6, 2017.

One final note, Obama’s last day as US President is Friday, Jan. 20, 2016 but his last ‘full’ day is Thursday, Jan. 19, 2016 (according to a Nov. 4, 2016 posting by Tom Muse for About.com).

International news bits: Israel and Germany and Cuba and Iran

I have three news bits today.

Germany

From a Nov. 14, 2016 posting by Lynn L. Bergeson and Carla N. Hutton for The National Law Review (Note: A link has been removed),

The German Federal Ministry of Education and Research (BMBF) recently published an English version of its Action Plan Nanotechnology 2020. Based on the success of the Action Plan Nanotechnology over the previous ten years, the federal government will continue the Action Plan Nanotechnology for the next five years.  Action Plan Nanotechnology 2020 is geared towards the priorities of the federal government’s new “High-Tech Strategy” (HTS), which has as its objective the solution of societal challenges by promoting research.  According to Action Plan Nanotechnology 2020, the results of a number of research projects “have shown that nanomaterials are not per se linked with a risk for people and the environment due to their nanoscale properties.”  Instead, this is influenced more by structure, chemical composition, and other factors, and is thus dependent on the respective material and its application.

A Nov. 16, 2016 posting on Out-Law.com provides mores detail about the plan (Note: A link has been removed),

Eight ministries have been responsible for producing a joint plan on nanotechnology every five years since 2006, the Ministry said. The ministries develop a common approach that pools strategies for action and fields of application for nanotechnology, it [Germany’s Federal Ministry of Education and Research] said.

The German public sector currently spends more than €600 million a year on nanotechnology related developments, and 2,200 organisations from industry, services, research and associations are registered in the Ministry’s nanotechnology competence map, the report said.

“There are currently also some 1,100 companies in Germany engaged [in] the use of nanotechnology in the fields of research and development as well as the marketing of commercial products and services. The proportion of SMEs [small to medium enterprises?] is around 75%,” it said.

Nanotechnology-based product innovations play “an increasingly important role in many areas of life, such as health and nutrition, the workplace, mobility and energy production”, and the plan “thus pursues the objective of continuing to exploit the opportunities and potential of nanotechnology in Germany, without disregarding any potential risks to humans and the environment.”, the Ministry said.

Technology law expert Florian von Baum of Pinsent Masons, the law firm behind Out-Law.com said: “The action plan aims to achieve and secure Germany’s critical lead in the still new nanotechnology field and to recognise and use the full potential of nanotechnology while taking into account possible risks and dangers of this new technology.”

..

“With the rapid pace of development and the new applications that emerge every day, the government needs to ensure that the dangers and risks are sufficiently recognised and considered. Nanotechnology will provide great and long-awaited breakthroughs in health and ecological areas, but ethical, legal and socio-economic issues must be assessed and evaluated at all stages of the innovation chain,” von Baum said.

You can find Germany’s Action Plan Nanotechnology 2020 here, all 64 pp.of it.

Israel and Germany

A Nov. 16, 2016 article by Shoshanna Solomon for The Times of Israel announces a new joint (Israel-Germany) nanotechnology fund,

Tsrael and Germany have set up a new three-year, €30 million plan to promote joint nanotechnology initiatives and are calling on companies and entities in both countries to submit proposals for funding for projects in this field.

“Nanotech is the industry of the future in global hi-tech and Israel has set a goal of becoming a leader of this field, while cooperating with leading European countries,” Ilan Peled, manager of Technological Infrastructure Arena at the Israel Innovation Authority, said in a statement announcing the plan.

In the past decade nanotechnology, seen by many as the tech field of the future, has focused mainly on research. Now, however, Israel’s Innovation Authority, which has set up the joint program with Germany, believes the next decade will focus on the application of this research into products — and countries are keen to set up the right ecosystem that will draw companies operating in this field to them.

Over the last decade, the country has focused on creating a “robust research foundation that can support a large industry,” the authority said, with six academic research institutes that are among the world’s most advanced.

In addition, the authority said, there are about 200 new startups that were established over the last decade in the field, many in the development stage.

I know it’s been over 70 years since the events of World War II but this does seem like an unexpected coupling. It is heartening to see that people can resolve the unimaginable within the space of a few generations.

Iran and Cuba

A Nov. 16, 2016 Mehr News Agency press release announces a new laboratory in Cuba,

Iran is ready to build a laboratory center equipped with nanotechnology in one of nano institutes in Cuba, Iran’s VP for Science and Technology Sorena Sattari said Tuesday [Nov. 15, 2016].

Sorena Sattari, Vice-President for Science and Technology, made the remark in a meeting with Fidel Castro Diaz-Balart, scientific adviser to the Cuban president, in Tehran on Tuesday [November 15, 2016], adding that Iran is also ready to present Cuba with a gifted package including educational services related to how to operate the equipment at the lab.

During the meeting, Sattari noted Iran’s various technological achievements including exports of biotechnological medicine to Russia, the extensive nanotechnology plans for high school and university students as well as companies, the presence of about 160 companies active in the field of nanotechnology and the country’s achievements in the field of water treatment.

“We have sealed good nano agreements with Cuba, and are ready to develop our technological cooperation with this country in the field of vaccines and recombinant drugs,” he said.

Sattari maintained that the biggest e-commerce company in the Middle East is situated in Iran, adding “the company which was only established six years ago now sales over $3.5 million in a day, and is even bigger than similar companies in Russia.”

The Cuban official, for his part, welcomed any kind of cooperation with Iran, and thanked the Islamic Republic for its generous proposal on establishing a nanotechnology laboratory in his country.

This coupling is not quite so unexpected as Iran has been cozying up to all kinds of countries in its drive to establish itself as a nanotechnology leader.

Sustainable nanotechnology systems: a conference

The Sustainable Nanotechnology Organization (SNO) is holding its 2016 conference from Nov. 10 – 12, 2016 according to Lynn L. Bergeson’s Oct. 17, 2016 posting on Nanotechnology Now,

The conference sessions will be organized around selected “systems,” and sessions will be populated with talks on applications, effects and implications, analytical methods, and lifecycle aspects of nanomaterials within each system. The aims are to identity where nanomaterials and nanotechnology can improve the sustainability of each system and to foster integration of knowledge between applications and implications within each system.

Here’s more from the 2016 SNO conference webpage,

In these systems of interest, we ask how we are helping reach sustainability through nanotechnology:

  1. Food/agricultural systems: Precision agriculture; pesticide delivery, nutrient delivery, improved food packaging and preservation; food fortification; stabilizing soil; human health and environmental implications.
  2. Energy systems: Energy storage; generation by solar and wind; energy transmission; CO2 capture and storage; plant efficiency improvements; system controls; air pollution control in fossil systems
  3. Air/Water systems: Drinking water treatment; air pollution controls, wastewater treatment; groundwater remediation; pollution prevention; disinfection; decreasing the energy footprint of water treatment; distribution systems; source water protection; lowering demand for water in industry and households, air filtration systems.
  4. Industry/Manufacturing (in general, not just nanomanufacturing) systems: Lowering process energy requirements; using more benign materials; safety of nanomaterials compared to alternatives; substitution for renewable resources; pollution prevention; monitoring systems for manufacturing; lifecycle releases of nanomaterials and models to predict exposure concentrations; economic sustainability of nanotechnology.
  5. Solid Waste (especially E-Waste) management: Recycling of nanomaterials; resource recovery from landfills; improved quality of recycled materials; advanced waste management
  6. Environmental/Biological systems: Ecotoxicity; ecosystem responses to nanomaterial releases; improved monitoring tools, exposure routes and exposure models for consumers and the environment; models for environmental fate and exposures of nanomaterials.
  7. Health/medical systems: Diagnostic tools for healthcare; nanomedicine and improved drug delivery; models for nanotoxicity prediction/reduction
  8. Urban systems: Improving construction materials; building more sustainable residences and commercial buildings; improving energy systems for heating and cooling; improving transportation systems (including increasing fuel efficiency; decreasing weight of vehicles; building better catalysts)
  9. Education systems: Curriculum development for sustainable nanotechnology, case studies, materials development, informal education networks
  10. Social systems and governance: Upcoming laws and regulations; systems of governance of nanomaterials; social justice concerns; education; calculating and communicating benefits (and risks) of nanotechnology

This conference is to bring together scientific experts from academia, industry, and government agencies from around the world to present and discuss current research findings on the theme. The SNO Conference emphasizes not only the environmental aspects of sustainability but also the societal and economic sustainability issues. The conference program will address the above topics from both a fundamental and applied viewpoint.

The conference will also foster new collaborations between academic and industrial participants. This community of users, researchers and developers of engineered nanomaterials will provide a long-term, scientific assessment of where the science is for sustainable nano, where it should be heading, and what steps academics, government agencies and others can take now to reach targeted goals. In addition, the conference will serve as the platform for continued advancement of the research community and the Sustainable Nanotechnology Organization (SNO), a non-profit, international professional society dedicated to advancing sustainable nanotechnology through education, research, and promotion of responsible development of nanotechnology.

The conference is being held in Orlando, Florida.

Germany has released a review of their research strategy for nanomaterials

A Sept. 24, 2016 posting by Lynn L. Bergeson and Carla N. Hutton on The National Law Review blog features a new report from German authorities (Note: A link has been removed),

On September 19, 2016, the Federal Institute for Occupational Safety and Health (BAuA) published a report entitled Review of the joint research strategy of the higher federal authorities — Nanomaterials and other advanced materials:  Application safety and environmental compatibility.  The report states that in a long-term research strategy, the higher federal authorities responsible for human and environmental safety — the German Environment Agency (UBA), the Federal Institute for Risk Assessment (BfR), BAuA, the Federal Institute for Materials Research and Testing (BAM), and the National Metrology Institute (PTB) — are accompanying the rapid pace of development of new materials from the points of view of occupational safety and health, consumer protection, and environmental protection.

Here’s a link to Review of the joint research strategy of the higher federal authorities — Nanomaterials and other advanced materials:  Application safety and environmental compatibility (PDF) and excerpts from the foreword (Note: There are some differences in formatting between what you see here and what you’ll see in the report),

The research strategy builds on the outcomes so far of the joint research strategy of the higher federal authorities launched in 2008 and first evaluated in 2013, “Nanotechnology: Health and Environmental Risks of Nanomaterials”1, while additionally covering other advanced materials where these pose similar risks to humans and the environment or where such risks need to be studied. It also takes up the idea of application safety of chemical products 2 from the New Quality of Work (INQA) initiative of the Federal Ministry of Labour and Social Affairs (BMAS) and the concept of sustainable
chemistry 3 endorsed by the Federal  Ministry  for  the  Environment, Nature Conservation, Building  and Nuclear Safety (BMUB). Application safety and environmental compatibility are aimed for advanced materials and derived products in order to largely rule out unacceptable risks to humans and the environment. This can be achieved by:

Using safe materials without hazardous properties for humans and the environment (direct application safety); or

Product design for low emissions and environmental compatibility over the entire product lifecycle (integrated application safety); or

Product stewardship, where producers support users in taking technical, organizational, and personal safety measures for the safe use and disposal of products (supported application safety).

As a comprising part of the Federal Government’s Nanotechnology Action Plan 2020, the update of the joint research strategy aims to contribute to governmental research in the following main areas:

 characterising and assessing the human and environmental risks of advanced materials
 Supporting research institutions and business enterprises
 Science-based revision of legal requirements and recommendations
 Public acceptance

The research strategy is to be implemented in projects and other research-related activities. These  include  governmental  research,  tendering  and  extramural  research  funding, and participation in mostly publicly supported projects with third-party funding. Additional activities will take place as part of policy advice and the ongoing work of the sovereign tasks of agencies involved. Interdisciplinary and transdisciplinary approaches will be used to better connect risk and safety research with innovation research and material development. In keeping up with the rapid pace of development, the time horizon for the research strategy is up to 2020. The research objectives address the research approaches likely to be actionable in this period. The research strategy will be supported by a working group and be evaluated and revised by the end of the Nanotechnology Action Plan 2020. tegy will be implemented in projects and other research-related activities, including governmental research, tendering and extramural research funding, and participation in mostly publicly supported projects with third-party funding.  Agencies will use interdisciplinary and transdisciplinary approaches to connect better risk and safety research with innovation research and material development. To keep up with the pace of development, the time horizon for the research strategy extends to 2020.  The research objectives in the report address the research approaches likely to be actionable in this period.  The research strategy will be supported by a working group and be evaluated and revised by the end of the Nanotechnology Action Plan 2020.

It’s always interesting to find out what’s happening elsewhere.

Nanosunscreen in swimming pools

Thanks to Lynn L. Bergeson’s Sept. 21, 2016 posting for information about the US Environmental Protection Agency’s (EPA) research into what happens to the nanoparticles when your nanosunscreen washes off into a swimming pool. Bergeson’s post points to an Aug. 15, 2016 EPA blog posting by Susanna Blair,

… It’s not surprising that sunscreens are detected in pool water (after all, some is bound to wash off when we take a dip), but certain sunscreens have also been widely detected in our ecosystems and in our wastewater. So how is our sunscreen ending up in our environment and what are the impacts?

Well, EPA researchers are working to better understand this issue, specifically investigating sunscreens that contain engineered nanomaterials and how they might change when exposed to the chemicals in pool water [open access paper but you need to register for free] … But before I delve into that, let’s talk a bit about sunscreen chemistry and nanomaterials….

Blair goes on to provide a good brief description of  nanosunscreens before moving onto her main topic,

Many sunscreens contain titanium dioxide (TiO2) because it absorbs UV radiation, preventing it from damaging our skin. But titanium dioxide decomposes into other molecules when in the presence of water and UV radiation. This is important because one of the new molecules produced is called a singlet oxygen reactive oxygen species. These reactive oxygen species have been shown to cause extensive cell damage and even cell death in plants and animals. To shield skin from reactive oxygen species, titanium dioxide engineered nanomaterials are often coated with other materials such as aluminum hydroxide (Al(OH)3).

EPA researchers are testing to see whether swimming pool water degrades the aluminum hydroxide coating, and if the extent of this degradation is enough to allow the production of potentially harmful reactive oxygen species. In this study, the coated titanium dioxide engineered nanomaterials were exposed to pool water for time intervals ranging from 45 minutes to 14 days, followed by imaging using an electron microscope.  Results show that after 3 days, pool water caused the aluminum hydroxide coating to degrade, which can reduce the coating’s protective properties and increase the potential toxicity.  To be clear, even with degraded coating, the toxicity measured from the coated titanium dioxide, was significantly less [emphasis mine] than the uncoated material. So in the short-term – in the amount of time one might wear sunscreen before bathing and washing it off — these sunscreens still provide life-saving protection against UV radiation. However, the sunscreen chemicals will remain in the environment considerably longer, and continue to degrade as they are exposed to other things.

Blair finishes by explaining that research is continuing as the EPA researches the whole life cycle of engineered nanomaterials.

Canada’s consultation on nanoscale forms of substances on the Domestic Substances List (DSL)

Yes, there’s a redundancy in the head but there doesn’t seem to be a way around it. Ah well, it seems about seven weeks after Peter Julian (Member of Parliament) introduced his bill in the Canadian House of Commons to regulate nanotechnology (Aug. 29, 2016 posting), Environment and Climate Change Canada (ECCC) and Health Canada (HC) have announced a consultation on nanoscale materials. From an Aug. 4, 2016 posting by Lynn L. Bergeson on Nanotechnology Now (Note: Links have been removed),

On July 27, 2016, Environment and Climate Change Canada (ECCC) and Health Canada (HC) began a consultation on a proposed prioritization approach for nanoscale forms of substances on the Domestic Substances List (DSL). See http://www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=FA3C8DBF-1 Canada will use the proposed approach to: (1) establish a list of existing nanomaterials in Canada for prioritization; (2) identify how the information available will be used to inform prioritization of nanomaterials for risk assessment; and (3) outline the proposed outcomes of the prioritization process. In 2015, Canada conducted a mandatory survey under Section 71 of the Canadian Environmental Protection Act, 1999 (CEPA). The survey applied to persons who manufactured or imported any of 206 nanomaterials at a quantity greater than 100 kilograms (kg) during the 2014 calendar year. See http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=28ABBAC9-1%20-%20s1 Based on the results of the survey, ECCC and HC will prepare a final list of confirmed existing nanomaterials in Canada and will use the list for subsequent prioritization. ECCC and HC propose that, where possible, the substances identified via the survey be “rolled up into” their broader parent nanomaterial groups for the purposes of prioritization. According to ECCC and HC, this will allow, when possible, a more robust look at the hazard, volume, and use data as appropriate, rather than considering an individual substance-by-substance approach. ECCC and HC state that further consideration for sub-grouping (such as by use, unique property, or functionalization) may need to be considered for prioritization and/or risk assessment. …

You can find the Government of Canada’s 2015 Consultation Document: Proposed Approach to Address Nanoscale Forms of Substances on the Domestic Substances List page here, which set the stage for this prioritization exercise.

You can also find the Proposed prioritization approach for nanoscale forms of substances on the Domestic substances list page here where you’ll find information such as this,

Possible nanomaterial groupings, based on parent substance

Aluminum oxide
Iron (II)/(II/III) oxide
Modified silica
Bismuth oxide
Magnesium oxide
Silicon oxide
Calcium carbonate
Manganese (II & III) oxide
Silver
Cerium oxide
Nanocellulose
Titanium dioxide
Cobalt (II) oxide
Nanoclays
Yttrium oxide
Copper (II) oxide
Nickel (II) oxide
Zinc oxide
Gold
Quantum dots
Zirconium oxide

You can also find information on how to submit comments,

Stakeholders are invited to submit comments on the content of this consultation document and provide other information that would help inform decision making. Please submit comments to one of the addresses provided below by September 25, 2016 [emphasis mine]. ECCC and HC will respond to comments and adapt the proposed approach based on the feedback received on this document, as described in Section 1.2.

Comments on this consultation document can be submitted to one of the following addresses:

By Mail:
Environment and Climate Change Canada
Substances Management Information Line
Chemicals Management Plan
351 St. Joseph Boulevard
Gatineau, Québec
K1A 0H3

By Email:
eccc.substances.eccc@canada.ca
Please type “Consultation on Prioritization Approach for Nanomaterials” in the subject line of your message.

By Fax:
819-938-5212

Suddenly, there’s lots (relative to the last few years) of action on nanotechnology regulation in Canada.

Everything old is new again: Canadian Parliament holds first reading of another bill to regulate nanotechnlogy

Back in March 2010, Canadian New Democratic Party (NDP) Member of Parliament (MP) Peter Julian introduced a bill to regulate nanotechnology (Bill C-494) in Canada. The Conservative government was in power at the time. I can’t remember how many readings it received but it never did get passed into legislation. Now, Mr. Julian is trying again and, coincidentally or not, the Liberals are in power this time. A July 26, 2016 post by Lynn L. Bergeson and Carla N. Hutton for the National Law Review (Note: Links have been removed),

On June 8, 2016, the Canadian House of Commons held its first reading of an Act to amend the Canadian Environmental Protection Act, 1999 (CEPA) (nanotechnology) (C-287).  The bill would add Part 6.1 to CEPA primarily to implement procedures for the investigation and assessment of nanomaterials. …

The bill would define nanomaterial as any manufactured substance or product or any component material, ingredient, device or structure that:  (a) is within the nanoscale (one nanometer (nm) up to and including 100 nm), in at least one external dimension; or (b) if it is not within the nanoscale, exhibits one or more properties that are attributable to the size of a substance and size effects.  The bill mandates a risk assessment process to identify the potential benefits and possible risks of nanotechnologies before nanoproducts enter the market.  It would also create a national inventory regarding nanotechnology, including nanomaterials and nanoparticles, using information collected under CEPA Sections 46 and 71 and “any other information to which the Ministers have access.” On July 25, 2015, Canada published a notice announcing a mandatory survey under CEPA Section 71(1)(b) with respect to certain nanomaterials in Canadian commerce.  …

I do have a few observations about the proposed bill. First, it’s more specific than what we have in place now. As I understand current CEPA regulations, they do not cover materials at the nanoscale which are already imported and/or produced at the macroscale and are considered safe, e.g. titanium dioxide. It is assumed that if they’re safe at the macroscale, they will be safe at the nanoscale. I gather this bill is designed to change that status.

Second, there is no mention in Julian’s press release (text to follow) of the joint Canada-United States Regulatory Cooperation Council (RCC) Nanotechnology Initiative which was designed to harmonize US and Canadian regulatory approaches to nanotechnology. Would bill C-287 introduce less harmony or was it designed to harmonize our approaches?

Third, I don’t see a big problem with the idea of an inventory, the issue is always implementation.

Finally, it appears that this bill means more bureaucrats or computerized systems and I’m not sure it addresses the problem that I believe it is trying to address: how to deal with uncertainty about the risks and hazards of an emerging technology while meeting demands for economic progress.

Very finally, here’s Peter Julian’s June 8, 2016 press release,

Julian’s bill to include Nanotechnology under Environmental Protection Act

You can watch the video here: https://peterjulian.ca/Introduction_of_Private_Member_Bill_C287_An_Act_t…

OTTAWA – Today [June 8, 2016], Peter Julian, MP (New Westminster-Burnaby) re-introduced Bill C-287 in the House of Commons, which aims to include a framework that would regulate nanotechnology in the Canadian Environmental Protection Act.

“I first introduced this Bill in 2010. I am pleased to see that some of the aspects of this Bill are being considered by Health Canada and Environment Canada, such as the development of a registry for nanomaterials in commerce and use in Canada. However, there is much more that needs to be done to ensure the responsible use of nanotechnologies in Canada”, said Julian.

Nanotechnology is the application of science and technology to manipulate matter at the atomic or molecular level. Nanomaterials are any ingredient, device, or structure that is between 1 and 100 nm. These materials are present in more than 1000 consumer products, including food and cosmetics. The increasing proliferation of nanoproducts has not been met with an adequate regulatory framework.

Julian’s Bill C-287 would establish a balanced approach ensuring the responsible development of nanotechnology and the safe use off nanomaterials in Canada. The Bill mandates a risk assessment process to identify the potential benefits and possible risks of nanotechnologies before nanoproducts enter the market. It would also require a comprehensive, publicly accessible database that lists existing nanomaterials identified by the Government of Canada.

“While nanotechnology can be very beneficial to people, there are certain risks to it as well. We must identify and mitigate possible risks to better protect the environment and human health before they become an issue. Canada must ensure our regulatory processes ensure nanomaterial safety before the introduction of these substances in Canada”, said Julian.

I’m including links to my 2010 email interview with Peter Julian (published in three parts),

March 24, 2010 (Part one)

March 25, 2010 (Part two)

March 26, 2010 (Part three)

I also covered a hearing on nanomaterials and safety held by the Canadian House of Commons Standing Committee on Health on June 10, 2010 in a June 23, 2010 posting.

Two nano workshops precede OpenTox Euro conference

The main conference OpenTox Euro is focused on novel materials and it’s being preceded by two nano workshops. All of of these events will be taking place in Germany in Oct. 2016. From an Aug. 11, 2016 posting by Lynn L. Bergeson on Nanotechnology Now,

The OpenTox Euro Conference, “Integrating Scientific Evidence Supporting Risk Assessment and Safer Design of Novel Substances,” will be held October 26-28, 2016. … The current topics for the Conference include: (1) computational modeling of mechanisms at the nanoscale; (2) translational bioinformatics applied to safety assessment; (3) advances in cheminformatics; (4) interoperability in action; (5) development and application of adverse outcome pathways; (6) open science applications showcase; (7) toxicokinetics and extrapolation; and (8) risk assessment.

On Oct. 24, 2016, two days before OpenTox Euro, the EU-US Nano EHS [Environmental Health and Safety] 2016 workshop will be held in Germany. The theme is: ‘Enabling a Sustainable Harmonised Knowledge Infrastructure supporting Nano Environmental and Health Safety Assessment’ and the objectives are,

The objective of the workshop is to facilitate networking, knowledge sharing and idea development on the requirements and implementation of a sustainable knowledge infrastructure for Nano Environmental and Health Safety Assessment and Communications. The infrastructure should support the needs required by different stakeholders including scientific researchers, industry, regulators, workers and consumers.

The workshop will also identify funding opportunities and financial models within and beyond current international and national programs. Specifically, the workshop will facilitate active discussions but also identify potential partners for future EU-US cooperation on the development of knowledge infrastructure in the NanoEHS field. Advances in the Nano Safety harmonisation process, including developing an ongoing working consensus on data management and ontology, will be discussed:

– Information needs of stakeholders and applications
– Data collection and management in the area of NanoEHS
– Developments in ontologies supporting NanoEHS goals
– Harmonisation efforts between EU and US programs
– Identify practice and infrastructure gaps and possible solutions
– Identify needs and solutions for different stakeholders
– Propose an overarching sustainable solution for the market and society

The presentations will be focused on the current efforts and concrete achievements within EU and US initiatives and their potential elaboration and extension.

The second workshop is being held by the eNanoMapper (ENM) project on Oct. 25, 2016 and concerns Nano Modelling. The objectives and workshop sessions are:

1. Give the opportunity to research groups working on computational nanotoxicology to disseminate their modelling tools based on hands-on examples and exercises
2. Present a collection of modelling tools that can span the entire lifecycle of nanotox research, starting from the design of experiments until use of models for risk assessment in biological and environmental systems.
3. Engage the workshop participants in using different modelling tools and motivate them to contribute and share their knowledge.

Indicative workshop sessions

• Preparation of datasets to be used for modelling and risk assessment
• Ontologies and databases
• Computation of theoretical descriptors
• NanoQSAR Modelling
• Ab-initio modelling
• Mechanistic modelling
• Modelling based on Omics data
• Filling data gaps-Read Across
• Risk assessment
• Experimental design

We would encourage research teams that have developed tools in the areas of computational nanotoxicology and risk assessment to demonstrate their tools in this workshop.

That’s going to be a very full week in Germany.

You can register for OpenTox Euro and more here.

Two European surveys on disposal practices for manufactured nano-objects

Lynn L. Bergeson’s Aug. 10, 2016 post on Nanotechnology Now announces two surveys (one for producers of nanoscale objects and one for waste disposal companies) being conducted by the European Commission,

Under European Commission (EC) funding, the European Committee for Standardization Technical Committee (CEN/TC) 352 — Nanotechnologies is developing guidelines relating to the safe waste management and disposal of deliberately manufactured nano-objects.

Tatiana Correia has written a July 15, 2016 description of the committee’s surveys for Innovate UK Network,

Under  the European Commission funding, CEN TC 352 European standardisation committee  are  developing guidelines relating to the safe waste management and  disposal of deliberately manufactured nano-objects. These are discrete pieces  of  material with one or more dimensions in the nanoscale(1). These may  also  be  referred  to  as  nanoparticles,  quantum  dots, nanofibres, nanotubes  and  nanoplates.  The  guidelines  will provide guidance for all waste  management  activities  from  the  manufacturing  and  processing of manufactured  nano-objects  (MNOs). In order to ensure that the context for this  document  is  correct,  it  is useful to gain an insight into current practice in the disposal of MNOs.

Here’s a link to the Questionnaire relating to current disposal practice for Manufactured Nano-objects in Waste – Companies manufacturing or processing manufactured nano-objects and to the Questionnaire relating to current disposal practice for Manufactured Nano-objects in Waste – Waste disposal companies.

The deadline for both surveys is Sept. 5, 2016.