Tag Archives: Lynn Bergeson

Harmonized nano terminology for environmental health and safety

According to Lynn Bergeson’s April 11, 2016 posting on Nanotechnology Now, the European Commission’s Joint Research Centre (JRC) has published a document about harmonizing terminology for environmental health and safety of nanomaterials,

The European Commission (EC) Joint Research Center (JRC) recently published a report entitled NANoREG harmonised terminology for environmental health and safety assessment of nanomaterials, developed within the NANoREG project: “A common European approach to the regulatory testing of nanomaterials.”

The NANoREG harmonised terminology for environmental health and safety assessment of nanomaterials (PDF)  has an unexpected description for itself on p. 8 (Note: A link has been removed),

Consistent  use  of  terminology  is  important  in  any  field  of  science  and  technology  to ensure  common  understanding  of  concepts  and  tools among  experts  and  different stakeholders, such as regulatory authorities, industry and consumers. Several  terms  in  the  field of  environmental  health  and  safety  (EHS)  assessment of nanomaterials  (hereinafter  NMs) have  been  indeed  defined  or  used  by  the  scientific community and various organisations, including   international   bodies,   European authorities, and industry associations.

This  is true  for multidisciplinary  projects  such  as  NANoREG, which  aims  at supporting regulatory  authorities, and  industry,  in  dealing  with EHS issues  of  manufactured NMs (‘nanoEHS’) (http://cordis.europa.eu/project/rcn/107159_en.html,www.nanoreg.eu). Terminology  thus  plays  an  important  role  in  NANoREG’s internal  process  of producing diverse types of output with regulatory relevance (e.g. physicochemical characterisation and test protocols, grouping and read-across approaches, exposure models, a framework for  safety  assessment  of NMs,  etc.). The  process  takes  place  in a  collaborative  effort across severalNANoREG work packages or tasks,  involvingquite a  few partners. Moreover,  the  different  types  of NANoREG output (‘deliverables’) are  addressed  to  a large  audience  of  scientists,  industry  and  regulatory  bodies,  extending beyond  Europe. Hence, a coordinated initiative has been undertaken by the Joint Research Centre (JRC) to harmonise the use of specific wording within NANoREG.

The objective of this JRC report is to disseminate the harmonised terminology that has been developed and used with in NANoREG. This collection of key terms has been agreed upon by all  project  partners and adopted  in  their  activities  and  related  documents, as recommended by the NANoREG internal Guidance Document.

Accordingly,  Section  2  of  the  report  illustrates  the  methodology  used  i)  to  select  key terms  that  form  the  ‘NANoREG  Terminology’,  ii)  to  develop  harmonised  ‘NANoREG Definitions’, and iii) it also explains the thinking that led to the choices made in drafting a  definition.  In  Section  3,  those  definitions, adopted  by  the  project  Consortium,  are reported  in  a  table  format  and  constitute  the  ‘NANoREG  Harmonised  Terminology’. Section 4 summarises the existing literature definitions that have been used as starting point to elaborate, for each key term, a NANoREG Definition. It also shortly discusses the reason(s) behind the choices that have been made in drafting a definition.

2. Methodology

The NANoREG Harmonised Terminology illustrated in this report is not a ‘dictionary’ [emphasis mine] that collects a long list of well-known, well-defined scientific and/or regulatory terms relevant to  the  field  of nanoEHS.  Rather,  the  NANoREG Harmonised  Terminology  focuses  on  a relatively short list of key terms that may be interpreted in various ways, depending on where the reader is located on the globe or on the reader’s scientific area of expertise. Moreover,  it  focuses  on  few  terms  that  are  specifically relevant  in  a  REACH [Registration, Evaluation, Authorization, & Restriction of Chemicals]  context, which represents the regulatory framework of reference for NANoREG.

This is having it both ways. As I read it, what they’re saying is this: ‘Our document is not a dictionary but here are the definitions we’re using and you can use them that way if you like’.

You can find a link to the ‘harmonisation’ document and one other related document on this page.

Québec’s second edition of its Best Practices Guidance for Nanomaterial Risk Management in the Workplace

Lynn Bergeson’s Dec. 16, 2015 posting on Nanotechnology Now highlights Québec’s second edition of its guide to best practices for handling nanomaterials in the workplace,

On December 11, 2015, the Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST), a leading occupational health and safety research center in Canada, published the second edition of its Best Practices Guidance for Nanomaterial Risk Management in the Workplace.

… IRSST intends the Guidance to support the safe development of nanotechnologies in Québec by bringing together current scientific knowledge on hazard identification, strategies for determining nanomaterial levels in different work environments, risk assessment, and the application of various risk management approaches. IRSST states that the Guidance provides practical information and prevention tools for the safe handling of nanomaterials in laboratories and pilot plants, as well as industrial facilities that produce or incorporate them. The Guidance recommends a preventive approach designed to minimize occupational exposure to nanomaterials. According to IRSST, given the different exposure pathways, the many factors that can affect nanomaterial toxicity and the health risks, its approach “is essentially based on hazard identification, different risk assessment strategies and a hierarchy of control measures, incorporating knowledge specific to nanomaterials when available.” The second edition of the Guidance incorporates new information in the scientific literature. In addition, IRSST has included appendices describing initiatives in Québec workplaces; examples of at-risk situations described in the literature; preventive measures and data on their relative efficacy; and the implementation of measures to control exposure. ,,,

The Best Practices Guidance for Nanomaterial Risk Management in the Workplace can be found here on the IRSST website where you’ll also find this description,

Today’s nanotechnologies can substantially improve the properties of a wide range of products in all sectors of activity, from the manufacture of materials with ground-breaking performance to medical diagnostics and treatment—yet they raise major technological, economic, ethical, social and environmental questions. Some of the spinoffs we can expect include the emergence of new markets, job creation, improvements in quality of life and contributions to protection of the environment. The impact of nanotechnologies is already being felt in sectors as diverse as agroprocessing, cosmetics, construction, healthcare and the aerospace industry. Most universities in Québec and many research centres are working to design new applications. Many companies have projects in the start-up phase, while others are already producing nanomaterials or have incorporated them in their processes to improve product performance, a trend expected to accelerate over the coming years. These new developments, which could mean exposure of a growing number of workers to these infinitesimally small particles, are of particular concern to workers in industry and staff in research laboratories. It is estimated that in 2015 about 10% of manufacturing jobs worldwide will be associated with nanotechnologies, [emphasis mine] and more than 2,000 commercial products will contain nanomaterials.

Given our fragmentary knowledge of the health and safety risks for workers and the environment, the handling of these new materials with their unique properties raises many questions and concerns. In fact, many studies have already demonstrated that the toxicity of certain nanomaterials differs from that of their bulk counterparts of the same chemical composition. Nanomaterials enter the body mainly through inhalation but also through the skin and the GI tract. Animal studies have demonstrated that certain nanomaterials can enter the blood stream through translocation and accumulate in different organs. Animal studies also show that certain nanomaterials cause more inflammation and more lung tumours on a mass-for-mass basis than the same substances in bulk form, among many other specific effects documented. In addition, research has shown that the physicochemical characteristics of nanomaterials (size, shape, specific surface area, charge, solubility and surface properties) play a major role in their impact on biological systems, including their ability to generate oxidative stress. It is thus crucial that risks be assessed and controlled to ensure the safe handling of nanomaterials. As with many other chemicals, a risk assessment and management approach must be developed on a case-by-case basis.

There is still no consensus, however, on a measurement method for characterizing occupational exposure to nanomaterials, making quantitative risk assessment difficult if not impossible in many situations. As a result, a precautionary approach is recommended to minimize worker exposure. In Québec, the employer is responsible for providing a safe work environment, and preventive measures must be applied by employees. Accordingly, preventive programs that take into account the specific characteristics of nanomaterials must be developed in all work environments where nanomaterials are handled, so that good work practices can be established and preventive procedures tailored to the risks of the particular work situation can be introduced.

Fortunately, current scientific knowledge, though partial, makes it possible to identify, assess and effectively manage these risks. This best practices guide is meant to support the safe development of nanotechnologies in Québec by bringing together current scientific knowledge on hazard identification, strategies for determining nanomaterial levels in different work environments, risk assessment and the application of various risk management approaches. Some knowledge of occupational hygiene is required to use this guide effectively. Designed for all work environments that manufacture or use nanomaterials, this guide provides practical information and prevention tools for the safe handling of nanomaterials in laboratories and pilot plants as well as industrial facilities that produce or incorporate them. To be effective, risk management must be an integral part of an organization’s culture, and health and safety issues must be considered when designing the workplace or as far upstream as possible. This is crucial for good organizational governance. In practice, risk management is an iterative process implemented as part of a structured approach that fosters continuous improvement in decision-making and can even promote better performance. The purpose of this guide is to contribute to the implementation of such an approach to the prevention of nanomaterial-related risks only. Depending on the process, other risks (associated with exposure to solvents, gas, heat stress, ergonomic stress, etc.) may be present, but they are not addressed in this guide.

I wonder where they got these numbers, “It is estimated that in 2015 about 10% of manufacturing jobs worldwide will be associated with nanotechnologies, and more than 2,000 commercial products will contain nanomaterials.” Given that many companies don’t like to disclose whether or not they’re using nanomaterials and most countries don’t insist on an inventory (there are voluntary inventories, which generally speaking have not been successful), bringing me back to the question: where did these numbers come from?

As for the guide itself, Canadians have been very involved with the OECD (Organization for Economic Cooperation and Development) and its ‘nanomaterial safety’ working group and, I understand, have provided leadership on occasion. The guide, which is available in both French and English, is definitely worth checking out.

US White House’s grand computing challenge could mean a boost for research into artificial intelligence and brains

An Oct. 20, 2015 posting by Lynn Bergeson on Nanotechnology Now announces a US White House challenge incorporating nanotechnology, computing, and brain research (Note: A link has been removed),

On October 20, 2015, the White House announced a grand challenge to develop transformational computing capabilities by combining innovations in multiple scientific disciplines. See https://www.whitehouse.gov/blog/2015/10/15/nanotechnology-inspired-grand-challenge-future-computing The Office of Science and Technology Policy (OSTP) states that, after considering over 100 responses to its June 17, 2015, request for information, it “is excited to announce the following grand challenge that addresses three Administration priorities — the National Nanotechnology Initiative, the National Strategic Computing Initiative (NSCI), and the BRAIN initiative.” The grand challenge is to “[c]reate a new type of computer that can proactively interpret and learn from data, solve unfamiliar problems using what it has learned, and operate with the energy efficiency of the human brain.”

Here’s where the Oct. 20, 2015 posting, which originated the news item, by Lloyd Whitman, Randy Bryant, and Tom Kalil for the US White House blog gets interesting,

 While it continues to be a national priority to advance conventional digital computing—which has been the engine of the information technology revolution—current technology falls far short of the human brain in terms of both the brain’s sensing and problem-solving abilities and its low power consumption. Many experts predict that fundamental physical limitations will prevent transistor technology from ever matching these twin characteristics. We are therefore challenging the nanotechnology and computer science communities to look beyond the decades-old approach to computing based on the Von Neumann architecture as implemented with transistor-based processors, and chart a new path that will continue the rapid pace of innovation beyond the next decade.

There are growing problems facing the Nation that the new computing capabilities envisioned in this challenge might address, from delivering individualized treatments for disease, to allowing advanced robots to work safely alongside people, to proactively identifying and blocking cyber intrusions. To meet this challenge, major breakthroughs are needed not only in the basic devices that store and process information and the amount of energy they require, but in the way a computer analyzes images, sounds, and patterns; interprets and learns from data; and identifies and solves problems. [emphases mine]

Many of these breakthroughs will require new kinds of nanoscale devices and materials integrated into three-dimensional systems and may take a decade or more to achieve. These nanotechnology innovations will have to be developed in close coordination with new computer architectures, and will likely be informed by our growing understanding of the brain—a remarkable, fault-tolerant system that consumes less power than an incandescent light bulb.

Recent progress in developing novel, low-power methods of sensing and computation—including neuromorphic, magneto-electronic, and analog systems—combined with dramatic advances in neuroscience and cognitive sciences, lead us to believe that this ambitious challenge is now within our reach. …

This is the first time I’ve come across anything that publicly links the BRAIN initiative to computing, artificial intelligence, and artificial brains. (For my own sake, I make an arbitrary distinction between algorithms [artificial intelligence] and devices that simulate neural plasticity [artificial brains].)The emphasis in the past has always been on new strategies for dealing with Parkinson’s and other neurological diseases and conditions.

Is safety all it’s cracked up to be? (three items about risk)

I have three items for this piece, two about human risk assessment and nanotechnology and one questioning the drive towards safety.

Proposal for a nanotechnology and human risk assessment scheme

A couple of academics, one from the Université de Montréal (Canada) and the other from the Université de Rennes (France) have proposed what they declare is a “well-developed human risk assessment (HRA) that applies to NPs (nanoparticles).” It’s a bold statement to be found in this paper (Note: There are some oddities about this paper’s citation),

Human Risk Assessment and Its Application to
Nanotechnology: A Challenge for Assessors (PDF) by Claude Emond and Luc Multigner.  2015 J. Phys.: Conf. Ser. 617 012039 http://iopscience.iop.org/1742-6596/617/1/01203

The first oddity is that the second author on the PDF version of the paper, Luc Multigner, is not listed on the paper’s page on the Journal of Physics website. where T N Britos is listed as the second author. Next, there’s the DOI (digital object identifier) which isn’t specified anywhere I can find it. There is something that looks like a DOI in the links to both the paper’s webpage and its PDF: 10.1088/1742-6596/617/1/012039.

Now on to the paper.

The authors are proposing that a methodology designed in 1983 (found in a document known as the Red Book) by the US National Research Council be adapted for use in nanotechnology human risk assessment,

… The approach divided the HRA into four different characterization steps: Source Identification Characterization (SIC), Exposure Assessment Characterization (EAC), Hazard Assessment Characterization (HAC) and Risk Assessment Characterization (RAC) [8, 9] (Figure 1).

Interspecies Variability Factors in Human Health Risk Assessment

This item comes from Lynn Bergeson’s Oct. 2, 2015 posting on Nanotechnology Now,

The Organization for Economic Cooperation and Development (OECD) posted a new publication in its Series on the Safety of Manufactured Nanomaterials, Preliminary Guidance Notes on Nanomaterials: Interspecies Variability Factors in Human Health Risk Assessment. See http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2015)31&doclanguage=en The report includes the following recommendations for further work:

– The Expert Opinion prepared in support of the project noted a general lack of availability of data from repeated-dose toxicity studies in different species. In particular, studies of extended duration such as 90-day subchronic or chronic toxicity studies were only available for a minor part of the analyzed nanomaterials and routes of exposures. …

– Physiologically-based models are receiving increased attention in human health risk assessment. With the available data on lung burden following inhalation exposure to nanomaterials, a useful comparison of measured vs. predicted data has been possible in this project for rats, suggesting that further refinement of the multiple path particle dosimetry (MPPD) model is required before it can be applied to (sub)chronic scenarios. Unfortunately, corresponding information has not been available for humans, preventing comparisons between rats and humans.

This document is no. 58 in the OECD (Organization for Economic Cooperation and Development) Series on the Safety of Manufactured Nanomaterials. All of these documents are freely available.

Why Safety Can Be Dangerous

The third and final item in this post is an announcement for an event at the Woodrow Wilson International Center for Scholars. From an Oct. 14, 2015 email,

Why Safety Can Be Dangerous: A Conversation with Gregory Ip

The Science & Technology Innovation Program is proud to welcome journalist Gregory Ip to discuss his latest book, Foolproof: Why Safety Can Be Dangerous and How Danger Makes Us Safe (Little, Brown). In Foolproof, Ip looks at how we often force new, unexpected risks to develop in unexpected places as we seek to minimize risk from crises like financial downturns and natural disasters.

More information about the Science & Technology Innovation Program’s Public Engagement in an Age of Complexity can be found here: http://www.wilsoncenter.org/article/public-engagement-age-complexity

Tuesday, October 20th, 2015
10:00am – 11:00am

6th Floor Auditorium

Directions

Wilson Center
Ronald Reagan Building and
International Trade Center
One Woodrow Wilson Plaza
1300 Pennsylvania, Ave., NW
Washington, D.C. 20004

Phone: 202.691.4000

The Foolproof event page provides more information,

In Foolproof, Ip looks at how we often force new, unexpected risks to develop in unexpected places as we seek to minimize risk from crises like financial downturns and natural disasters. This is a phenomena only likely to increase as our financial systems and cities become more complex and interconnected, but Ip concludes that these crises actually benefit society.

Final comments

We’re always engaged in a balancing act between risk and safety. How we resolve that conundrum can have huge and unexpected impacts on our future.

As an example of unintended consequences, I live in a region with many forests and a very successful fire suppression programme. Risk from forest fires has been reduced at the cost of building up  so much debris on the forest floor that forest fires which do occur are more devastating than if theyhad regularly diminished the debris.

Funding trends for US synthetic biology efforts

Less than 1% of total US federal funding for synthetic biology is dedicated to risk research according to a Sept. 16, 2015 Woodrow Wilson International Center for Scholars news release on EurekAlert,

A new analysis by the Synthetic Biology Project at the Wilson Center finds the Defense Department and its Defense Advanced Research Projects Agency (DARPA) fund much of the U.S. government’s research in synthetic biology, with less than 1 percent of total federal funding going to risk research.

The report, U.S. Trends in Synthetic Biology Research, finds that between 2008 and 2014, the United States invested approximately $820 million dollars in synthetic biology research. In that time period, the Defense Department became a key funder of synthetic biology research. DARPA’s investments, for example, increased from near zero in 2010 to more than $100 million in 2014 – more than three times the amount spent by the National Science Foundation (NSF).

The Wilson Center news release can also be found here on the Center’s report publication page where it goes on to provide more detail and where you can download the report,

The report, U.S. Trends in Synthetic Biology Research, finds that between 2008 and 2014, the United States invested approximately $820 million dollars in synthetic biology research. In that time period, the Defense Department became a key funder of synthetic biology research. DARPA’s investments, for example, increased from near zero in 2010 to more than $100 million in 2014 – more than three times the amount spent by the National Science Foundation (NSF).

“The increase in DARPA research spending comes as NSF is winding down its initial investment in the Synthetic Biology Engineering Research Center, or SynBERC,” says Dr. Todd Kuiken, senior program associate with the project. “After the SynBERC funding ends next year, it is unclear if there will be a dedicated synthetic biology research program outside of the Pentagon. There is also little investment addressing potential risks and ethical issues, which can affect public acceptance and market growth as the field advances.”

The new study found that less than one percent of the total U.S. funding is focused on synthetic biology risk research and approximately one percent addresses ethical, legal, and social issues.

Internationally, research funding is increasing. Last year, research investments by the European Commission and research agencies in the United Kingdom exceeded non-defense spending in the United States, the report finds.

The research spending comes at a time of growing interest in synthetic biology, particularly surrounding the potential presented by new gene-editing techniques. Recent research by the industry group SynBioBeta indicated that, so far in 2015, synthetic biology companies raised half a billion dollars – more than the total investments in 2013 and 2014 combined.

In a separate Woodrow Wilson International Center for Scholars Sept. 16, 2015 announcement about the report, an upcoming event notice was included,

Save the date: On Oct. 7, 2015, the Synthetic Biology Project will be releasing a new report on synthetic biology and federal regulations. More details will be forthcoming, but the report release will include a noon event [EST] at the Wilson Center in Washington, DC.

I haven’t been able to find any more information about this proposed report launch but you may want to check the Synthetic Biology Project website for details as they become available. ETA Oct. 1, 2015: The new report titled: Leveraging Synthetic Biology’s Promise and Managing Potential Risk: Are We Getting It Right? will be launched on Oct. 15, 2015 according to an Oct. 1, 2015 notice,

As more applications based on synthetic biology come to market, are the existing federal regulations adequate to address the risks posed by this emerging technology?

Please join us for the release of our new report, Leveraging Synthetic Biology’s Promise and Managing Potential Risk: Are We Getting It Right? Panelists will discuss how synthetic biology applications would be regulated by the U.S. Coordinated Framework for Regulation of Biotechnology, how this would affect the market pathway of these applications and whether the existing framework will protect human health and the environment.

A light lunch will be served.

Speakers

Lynn Bergeson, report author; Managing Partner, Bergeson & Campbell

David Rejeski, Director, Science and Technology Innovation Program

Thursday,October 15th, 2015
12:00pm – 2:00pm

6th Floor Board Room

Directions

Wilson Center
Ronald Reagan Building and
International Trade Center
One Woodrow Wilson Plaza
1300 Pennsylvania, Ave., NW
Washington, D.C. 20004

Phone: 202.691.4000

RSVP NOW »

Canada and a mandatory survey on nanomaterials due February 2016

If memory serves, this is the second nanomaterials reporting survey that the Canadian federal government has requested in the seven years that I’ve blogging on the topic Canadian nanotechnology. (As usual, I’ve gotten my information from a source outside the country.) Thanks to Lynn Bergeson (US lawyer) and her July 27, 2015 posting on Nanotechnology Now where she covers nanotechnology’s regulatory developments (Note: A link has been removed),

The July 25, 2015, Canada Gazette includes a notice announcing that the Minister of the Environment requires, for the purpose of assessing whether the substances described in the notice are toxic or are capable of becoming toxic, or for the purpose of assessing whether to control, or the manner in which to control the listed substances, any person described in the notice who possesses or who may reasonably be expected to have access to the information required to provide that information. See http://www.gazette.gc.ca/rp-pr/p1/2015/2015-07-25/html/notice-avis-eng.php The notice applies to a substance that has a size of between 1 and 100 nanometers in at least one external dimension, or internal or surface structure; and is provided in the list in Schedule 1 of the notice. The list includes over 200 substances. The notice applies to any person who, during the 2014 calendar year, manufactured a total quantity greater than 100 kilograms (kg) of a substance set out in Schedule 1. …

You can find the Canada Gazette notice (Notice with respect to certain nanomaterials in Canadian commerce) here: http://www.gazette.gc.ca/rp-pr/p1/2015/2015-07-25/html/notice-avis-eng.php but you may find the Guidance for responding to the Notice: http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=AACFB2C0-1 more helpful (Note: Links have been removed),

1.1- Purpose of the Notice

In 2011, the Canada-United States Regulatory Cooperation Council (RCC) Nanotechnology InitiativeFootnote[1] was launched to increase alignment in regulatory approaches for nanomaterials between Canada and the US to reduce risk to human health and the environment; to promote sharing of scientific and regulatory expertise; and to foster innovation. Completed in February 2014, the RCC Nanotechnology Initiative included a work element on Commercial Information.Footnote[2] This work element was aimed at increasing knowledge of commercial uses of nanomaterials in Canada and the US. The primary output from this work element was a Nanomaterials Use Matrix which identified nanomaterials by type and use category based on the most up-to-date information, at the time, on commercially available nanomaterials. The nanomaterial types were cross-referenced with the DSL to identify nanomaterials which could be considered existing in Canada. The result is a preliminary reference list and may not be comprehensive of all nanomaterials. Ongoing engagement with stakeholders through voluntary initiatives and other fora will inform further development of the list of existing nanomaterials in Canada.

The purpose of the Notice is to gather information on 206 nanomaterials identified as potentially in commerce in Canada from the primary reference list. [emphasis mine] The information collected from the Notice will support the development of a list of nanomaterials in commerce in Canada by confirming their commercial status, and subsequent prioritization activities for these substances, which may include risk assessment and risk management activities, if required. This will ensure that future decision making is based on the best available information.

The list of reportable substances is long and not alphabetized but before you check you may want to review this,

2.1- Reporting criteria

To determine whether a company is required to respond, the following factors must be considered:

Type of substance (i.e., nanoscale form)
Type of activity
Calendar year
Quantity
The quantity should be determined based on the quantity of the substance itself at the nanoscale, and not on the quantity of the product or mixture containing the substance.

The purpose of the Notice is to gather information on nanomaterials in commerce in Canada. A response is only required if the conditions set out in Schedule 1 and Schedule 2 of the notice are met.

The Notice applies to any person who, during the 2014 calendar year [emphasis mine], satisfied any of the following criteria:

Manufactured a total quantity greater than 100 kg of a substance listed in Schedule 1 that is at the nanoscale.
Imported a total quantity greater than 100 kg of a substance listed in Schedule 1 that is at the nanoscale, at any concentration, whether alone, in a mixture or in a product.

The reporting threshold of 100 kg is based on activity with the substance in the nanoscale (i.e. you manufacture, or imported a total quantity greater than 100 kg of a substance with a size between 1 and 100 nanometres, inclusive, in at least one external dimension, or internal or surface structure).

Your response to the information requested should also be based on activities with the substance in the nanoscale.

If you are engaged with a substance that is not in the nanoscale (i.e. same CAS RN, but not nanoscale) and would like to identify yourself as a stakeholder for that substance, you may submit a Declaration of Stakeholder Interest (see section 7 of this document).

You may find this flowchart (from the guidance webpage), useful,

Figure 1:  Reporting Diagram for Nanomaterials [downloaded from: http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=AACFB2C0-1]

Figure 1: Reporting Diagram for Nanomaterials [downloaded from: http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=AACFB2C0-1]

The information you provide needs to cover the 2014 calendar year and is due,

10. Responding to the Notice

Responses to the Notice must be provided no later than February 23, 2016, 5 p.m. Eastern Standard Time using the online reporting system available through Environment Canada’s Single Window available from the Chemical Substances Web site.

Good luck to all those who must report.

Outcomes for US-European Union bridging Nano environment, health, and safety (EHS) research workshop

According to Lynn Bergeson in an April 14, 2015 news item on Nanotechnology Now, a US-European Union (EU) workshop on nanosafety has published a document,

The National Nanotechnology Initiative (NNI) published on March 23, 2015, the outcomes of the March 12-13, 2015, joint workshop held by the U.S. and the European Union (EU), “Bridging NanoEHS Research Efforts.” …

A US National Nanotechnology Initiative (NNI) ??, ??, 2015 notice on the nano.gov site provides more details,

Workshop participants reviewed progress toward COR [communities of research] goals and objectives, shared best practices, and identified areas for cross-COR collaboration.  To address new challenges the CORs were realigned and expanded with the addition of a COR on nanotechnology characterization. The seven CORs now address:

Characterization
Databases and Computational Modeling
Exposure through Product Life
EcoToxicity
Human Toxicity
Risk Assessment
Risk Management and Control

The CORs support the shared goal of responsible nanotechnology development as outlined in the U.S. National Nanotechnology Initiative EHS Research Strategy, and the research strategy of the EU NanoSafety Cluster. The CORs directly address several priorities described in the documents above, including the creation of a comprehensive nanoEHS knowledge base and international cooperation on the development of best practices and consensus standards.

The CORs are self-run, with technical support provided by the European Commission and the U.S. National Nanotechnology Coordination Office. Each Community has European and American co-chairs who convene meetings and teleconferences, guide the discussions, and set the group’s agenda. Participation in the CORs is free and open to any interested individuals. More information is available at www.us-eu.org.

The workshop was organized by the European Commission and the U.S. National Nanotechnology Initiative under the auspices of the agreement for scientific and technological cooperation between the European Union and the United States.

Coincidentally, I received an April 13, 2015 notice about the European Commission’s NanoSafety Cluster’s Spring 2015 newsletter concerning their efforts but found no mention of the ‘bridging workshop’. Presumably, information was not available prior to the newsletter’s deadline.

In my April 8, 2014 posting about a US proposed rule for reporting nanomaterials, I included information about the US and its efforts to promote or participate in harmonizing the nano situation internationally. Scroll down about 35% of the way to find information about the Canada-U.S. Regulatory Cooperation Council (RCC) Nanotechnology Initiative, the Organisation for Economic Cooperation and Development (OECD) effort, and the International Organization for Standardization (ISO) effort.

Government of Canada’s risk assessment for multi-walled carbon nanotubes

Lynn Bergeson’s Jan. 15, 2015 post on the Nanotechnology Now website mentions a newly issued Canadian risk assessment for multi-walled carbon nanotubes (MWCNTs),

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. …

Here’s more information from the Summary of Risk Assessment Conducted Pursuant to subsection 83(1) of the Canadian Environmental Protection Act, 1999
Significant New Activity No. 17192: Multi-wall carbon nanotubes webpage,

Substance Identity

The substance is a short tangled multi-walled carbon nanotube that can be classified as a nanomaterial. [emphasis mine]

Notified Activities

The substance is proposed to be manufactured in or imported into Canada in quantities greater than 1000 kg/yr for use as an additive in plastics.

Environmental Fate and Behaviour

Based on its physical and chemical properties, if released to the environment, the substance will tend to partition to water, sediment, soil, and ambient air. The substance is expected to be persistent in these compartments because it is a stable inorganic chemical that will not degrade. Based on the limited understanding of uptake by organisms, more data is required to assess the bioaccumulation potential of this substance at the current schedule notification.

Ecological Assessment

Based on the available hazard information on the substance and surrogate data on structurally related nanomaterials, the substance has low to moderate (1-100 mg/L) acute toxicity in aquatic life (fish/daphnia/algae). The predicted no effect concentration was calculated to be less than 1 mg/L using the ErC50 from the most sensitive organism (P. subcapitata), which was used to estimate the environmental risk.

The notified and other potential activities in Canada were assessed to estimate the environmental exposure potential of the substance throughout its life cycle. Environmental exposure from the notified activities was determined through a conservative generic single point-source release blending scenario. The predicted environmental concentration for notified activities is estimated to be 2.1 µg/L.

Based on the current use profile in conjunction with low to moderate ecotoxicity endpoints, the substance is unlikely to cause ecological harm in Canada.

However, based on the current understanding of carbon nanotubes and nanomaterials in general, a change in the use profile of the substance (SNAc No. 17192) may significantly alter the exposure resulting in the substance becoming harmful to the environment.  Consequently, more information is necessary to better characterize potential environmental risks.

Human Health Assessment

Based on the available hazard information on the substance, the substance has a low potential for acute toxicity by the oral, dermal and inhalation routes of exposure (oral and dermal LD50 greater than 2000 mg/kg bw; inhalation LC50 greater than 1.3 mg/m3). It is a severe eye irritant (MAS score = 68), a mild skin irritant (PII = 1.08) and at most a weak sensitizer (because the positive control was tested at a concentration 10X higher than the test substance). It is not an in vitro mutagen (negative in a mammalian cell gene mutation test and in a mammalian chromosome aberration test).  Therefore the substance is unlikely to cause genetic damage.

Hazards related to substances used in the workplace should be classified accordingly under the Workplace Hazardous Materials Information System (WHMIS).

However, based on the available information on structurally related nanomaterials, the substance may cause respiratory toxicity, immunotoxicity, cardiovascular toxicity and carcinogenicity following oral and inhalation exposure.

When used as an additive in plastics, the substance is expected to be manufactured in or imported into Canada encapsulated in a solid polymer matrix. The potential site of exposure to the substance is expected to be within industrial facilities. Therefore, direct exposure of the general population is expected to be low. No significant environmental release is anticipated due to the specialized use under this notification and therefore indirect exposure of the general population from environmental media is also expected to be low. However, if the substance is produced in different forms (e.g. liquid polymer form), applied in different formulations or used in any other potential applications, an increased direct or indirect exposure potential may exist.

Based on the low potential for direct and indirect exposure of the general population under the industrial uses identified in this submission, the substance is not likely to pose a significant health risk to the general population, and is therefore unlikely to be harmful to human health.

However, based on the current understanding of carbon nanotubes and of nanomaterials in general, the risk arising from the use of the substance in consumer products is not known at this time.  The use of the substance in consumer products or in products intended for use by or for children may significantly alter the exposure of the general population resulting in the substance becoming harmful to human health.  Similarly, the import or manufacture of the substance in quantities greater than 10 000 kg/yr may significantly increase the exposure levels of the general population resulting in the substance becoming harmful to human health.  Consequently, more information is necessary to better characterize potential health risks.

I would like to see a definition for the word short as applied, in this risk assessment, to multi-walled carbon nanotubes. That said, this assessment is pretty much in line with current thinking about short, multi-walled carbon nanotubes. In short (wordplay noted), these carbon nanotubes are relatively safe (although some toxicological issues have been noted) as far as can be determined. However, the ‘relatively safe’ assessment may change as more of these carbon nanotubes enter the environment and as people are introduced to more products containing them.

One last comment, I find it surprising I can’t find any mention in the risk assessment of emergency situations such as fire, earthquake, explosions, etc. which could conceivably release short multi-walled carbon nanotubes into the air exposing emergency workers and people caught in a disaster. As well, those airborne materials might subsequently be found in greater quantity in the soil and water.

OECD’s (Organization for Economic Cooperation and Development) latest report on its regulating manufactured nanomaterials questionnaire

As I have commented on several occasions, most of my information about Canada’s activities with regard to risk and nanomaterials comes from outside the country, notably the OECD (Organization for Economic Cooperation and Development).

Thanks* to Lynn Bergeson and her Sept. 17, 2014 posting on Nanotechnology Now for information about the latest publication from the OECD’s Working Party on Manufactured Nanomaterials (Note: a link has been removed),

On September 16, 2014, the Organization for Economic Cooperation and Development (OECD) published a document entitled Report of the Questionnaire on Regulatory Regimes for Manufactured Nanomaterials 2010-2011. … The Report summarizes responses to the Working Party on Manufactured Nanomaterials (WPMN) Questionnaire on Regulated Nanomaterials: 2010-2011, which was issued July 12, 2012. The Questionnaire contained four sections related to the oversight of nanomaterials in various OECD jurisdictions: regulatory updates; definitions and/or legal approaches for nanomaterials by jurisdiction; regulatory challenges; and opportunities for collaboration.

You can find all of the reports from the OECD’s WPMN here, including this latest report, which is no. 42, Report of the questionnaire on regulatory regimes for manufactured nanomaterials 2010-201, ENV/JM/MONO(2014)28. This is the third time there’s been a questionnaire and subsequent report.

I have quickly skimmed through the report and found a few interesting items about Canada’s current activities and collaborations vis à vis manufactured nanomaterials and risk. From the REPORT OF THE QUESTIONNAIRE ON REGULATORY REGIMES FOR MANUFACTURED NANOMATERIALS 2010-2011 which appears to have been published Sept. 4, 2014. I have had an unusually difficult time including excerpts from the report along with page numbers, etc. On the first try, after almost an hour of cutting and pasting, I was unable to get an intelligible version into a preview. To all intents and purposes the text was in place but the preview attempt resulted in a bizarre column of text overwriting the sidebar to the right of the posts.

I tried again and found that extensive reformatting was necessary and that the original table format has been lost. Nonetheless. you will find there are two pieces of legislation being reported on, CEPA (1999), which I believe has something to do with Environment Canada, and F&DA, which seems to be associated with Health Canada. One or both pieces of legislation may be referenced as per the OECD report. Page numbers from the document are included after the excerpted table entries.

Table 12: Hazard identification …

CEPA (1999)

Extrapolation between nanomaterials (i.e., choosing the appropriate surrogate)

Validity of testing methods and analytical tools to detect, characterize and measure nanomaterials

Participating in international forums such as the WPMN [OECD Working Party on Manufactured Nanomaterials], Expert Meetings, and ISO [International Standards Organization] TC/229 to support the generation and synthesis of appropriate science.

Support domestic research to help minimize challenges in hazard identification.

F&DA

Nanomaterial-based products under the F&DA (i.e. nanomedicines) can be associated with a broad spectrum of toxicities that are dependent on the nanoparticle properties (e.g. size, surface charge and solubility). However, there is currently no specific guidance document available for nanomedicines. Nanoparticle properties can significantly impact the PK profile/biodistribution of nanomedicines resulting in safety concerns. The components of the nanomedicines can also interact with the immune system and may trigger unique immunogenicity/immunotoxicity profile. Animals are generally not predictive of immunological responses for biologics (however, it may not be the case if the nanomedicine is a chemical drug), it is likely that immunological studies for nanomedicines should be carried out in human clinical trials. Long term studies may be required for a nanomaterial that persist and accumulated in particular tissues for an extended period of time.  p. 45

Table 13: Health and safety …

F&DA Veterinary Drugs

Due to the lack of a comprehensive understanding of the effects of nanomaterials on human, animal and environmental health, the Veterinary Drugs Directorate has not yet established a comprehensive occupational health and safety policy. Moreover, occupational health and safety is a shared responsibility between the federal and provincial governments in Canada.

At this time, there is no conclusive evidence linking exposure of nanomaterials from veterinary drugs or food sources to negative impact on human health. Additional research is necessary before a definitive policy approach can be taken.

F&DA Veterinary Drugs
Veterinary drugs including those that contain nanomaterials are regulated by the Food and Drugs Act and the Food and Drug Regulations. These provide the Veterinary Drugs Directorate with the authority to regulate the human health and safety aspects of veterinary drug products. The Regulations cover the aspects of the manufacturing, human and animal safety and efficacy assessment, and post-market surveillance of veterinary drug products including those containing nanomaterials. The latter products are subject to the same rigorous assessments as non-nanomaterial-containing veterinary drug products. p. 47

Table 14: Risk Assessment Methodologies

CEPA (1999)

Our understanding of risk assessments of nanomaterials is still evolving. Nanomaterials regulated under the industrial chemicals program employ a precautionary approach (i.e., exposure is typically mitigated), and nano-relevant information is requested whenever appropriate to conduct more informed risk assessments.

Canada also continues to work in international projects, such as the international life sciences institute NanoRelease project aimed at developing methods to quantify releases of nanomaterials from solid matrices.

Canada is also part of the Regulatory Cooperation Council (RCC) Nanotechnology Initiative with the United States. Under this project, Canada and the US are developing a classification scheme for nanomaterials to inform on the utilization of analogue/read- across, developing frameworks and common assumptions to better
inform risk assessments, and mining public and confidential use information to increase marketplace knowledge of nanomaterials. p. 49

Table 15: Risk Management and Nanomaterials in Commerce …

CEPA (1999)

Knowledge of use profiles of industrial nanomaterials; lack of specificity in risk
management measures given the overall lack of information and nomenclature systems for nanomaterials

Under the RCC, Canada and the US are gathering information on the uses of industrial nanomaterials in the two countries.  p. 52

Table 16: Research … (to support regulatory decisions)

CEPA (1999)

– foster domestic and international capacity to generate research on risk assessment priorities and needs
– applying research findings to nanomaterial risk assessments
– using research on nanomaterials to extrapolate to other nanomaterials

– Canada is actively supporting domestic and international research projects to help inform risk assessments.

F&DA

Filling knowledge gaps

HC [Health Canada] is conducting laboratory research to study the effects of lipid nanoparticles on the thermal stability of various recombinant proteins with the aim of identifying determinants of susceptibility to unintended deleterious interactions.  p. 55

Table 17: Impact of Regulatory Actions and Innovations and Economic Growth

CEPA (1999)

How to obtain the necessary information on nanomaterials, and how to regulate them in a manner that does not prevent them from offering their many benefits to society.

Consult with industry on proposed approaches. Focus information requests and requirements.  pp. 56/7

Table 18: Labelling Communication of Nanomaterials …

CEPA (1999)

Labelling of nanomaterials has not been considered under CEPA 1999 to date. p. 58

Table 19: Collaboration with other countries …

CEPA (1999) & F&DA

New Substances Program is involved in various international activities, including:
1) International Organization for Standardization (ISO) Technical Committee (TC) 229 on Nanotechnologies
2) Organisation for Economic Co-operation and Development (OECD) Working Party on
Manufactured Nanomaterials (WPMN) and Working Party on Nanotechnology (WPN)
3) Canada-US Regulatory Cooperation Council (RCC)
4) International Cooperation on Cosmetic Regulation (ICCR) – 2 Reports have been published
a) Criteria and Methods of Detection for Nanomaterials in Cosmetics:
http://www.fda.gov/downloads/InternationalPrograms/HarmonizationInitiatives/UCM235485.pdf
b) Methods for Characterization of Nanomaterials in Cosmetics
http://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/iccr5_char_nano_en.pdf
5) International Regulators Nanotechnology Working Group
6) International Life Sciences Institutes (ILSI) – NanoRelease Food Additive Project
7) NanoLyse

In addition, for veterinary drugs, Health Canada collaborates with other regulatory agencies in USA, Europe, Australia, etc in the regulation of non-nanomaterial products and substances and would do the same for substances that are, or products containing nanomaterials pp. 59/60

Table 19: Expert Workshop Sponsorship [table number repetition noted]

CEPA (1999)

The Workshop on the Human and Environmental Risk Assessment of Nanomaterials convened by Health Canada and Environment Canada (March 24-26, 2010) provided an open forum for detailed dialogue on nanomaterials among science evaluators, research scientists and regulators. The Workshop was attended by 25 experts from Australia, Canada, Europe, Korea and the United States of America. In addition, seven observers attended the Workshop.

Regulatory Cooperation Council with the United States

F&DA Foods

Health Canada will be hosting a Joint NanoLyse/NanoRelease Workshop to discuss methods and safety of nanomaterials and share information from the respective projects. NanoLyse is an EU research consortium to develop methods of analysis for engineered nano-materials in foods and NanoRelease is an International Life Sciences Institute lead initiative to develop of analytical methods, alimentary canal models for uptake of engineered nano-materials and review of regulatory issues. p. 61

In any event, good luck with the reading and you can find out more about NanoLyse here and more about Canadian participation in the NanoRelease Food Additive Steering Committee project here.

* ‘Thank’s’ changed to ‘Thanks’ on April 7, 2015