Tag Archives: Environment Canada

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).

Thank’s 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.

Deadline extension (travel grants and poster abstracts) for alternate testing strategies (ATS) of nanomaterials workshop

It seems there have been a couple of deadline extensions (to August 1, 2014) for the September 15-16, 2014 ‘Workshop to Explore How a Multiple Models Approach can Advance Risk Analysis of Nanoscale Materials’ in Washington, DC (first mentioned in my July 10, 2014 posting featuring a description of the workshop). You can go here to submit a poster abstract (from any country) and you can go here if you’re a student or young professional (from any country) in search of a $500 travel award.

I managed to speak to one of the organizers, Lorraine Sheremeta, (Assistant Director, Ingenuity Lab, University of Alberta and co-author a July 9, 2014 Nanowerk Spotlight article about the workshop). Lorraine (Lori) kindly spoke to me about the upcoming workshop, which she described as an academic conference,.

As I understand what she told me, the hosts for the September 15-16, 2014 Workshop to Explore How a Multiple Models Approach can Advance Risk Analysis of Nanoscale Materials in Washington, DC want to attract a multidisciplinary group of people to grapple with a few questions. First, they want to establish a framework for establishing which are the best test methods for nanomaterials. Second, they are trying to move away from animal testing and want to establish which methods are equal to or better than animal testing. Thirdly, they want to discuss what they are going to do with the toxicological data  that we have  been collecting on nanomaterials for years now.

Or, as she and her colleague from the Society of Risk Analysis (Jo Anne Shatkin) have put in it in their Nanowerk Spotlight article:

… develop a report on the State of the Science for ATS for nanomaterials, catalogue of existing and emerging ATS [alternate testing strategies] methods in a database; and develop a case study to inform workshop deliberations and expert recommendations

The collaborative team behind this event includes, the University of Alberta’s Ingenuity Lab, the Society for Risk Analysis, Environment Canada, Health Canada, and the Organization for Economic Co-operation and Development (OECD) Working Party on Manufactured Nanomaterials (WPMN) .

The speaker lineup isn’t settled at this time although they have confirmed Vicki Stone of Heriot-Watt University in Scotland (from her university bio page),

Vicki Stone, Professor of Toxicology, studies the effects of nanomaterials on humans and environmentally relevant species.  Current research projects investigate the mechanism of toxicity of a range of nanomaterials in cells of the immune system (macrophages and neutrophils), liver (hepatocytes) , gastrointestinal tract, blood vessels (endothelium) and lung.  She is interested in interactions between nanomaterials, proteins and lipids, and how this influences subsequent toxicity.  Current projects also develop in vitro alternatives using microfluidics as well as high resolution imaging of individual nanomaterials in 3D and over time.  In addition Vicki collaborates with ecotoxicologists to investigate the impacts of nanomaterials on aquatic organisms. Vicki coordinated a European project to identify the research priorities to develop an intelligent testing strategy for nanomaterials (www.its-nano.eu).

Vicki is Director of the Nano Safety Research Group at Heriot-Watt University, Edinburgh, and Director of Toxicology for SAFENANO (www.safenano.org). She has acted as the Editor-in-chief of the journal Nanotoxicology (http://informahealthcare.com/nan) for 6 years (2006-2011). Vicki has also published over 130 publications pertaining to particle toxicology over the last 16 years and has provided evidence for the government commissioned reports published by the Royal Society (2003) and the on Environmental Pollution (2008).  Vicki was previously a member of the UK Government Committee on the Medical Effects of Air Pollution (COMEAP) and an advisory board member for the Center for the Environmental Implications of NanoTechnology (CEINT; funded by the US Environmental Protection Agency)).

A representative from PETA (People for the Ethical Treatment of Animals) will also be speaking. I believe that will be Amy Clippinger (from the PETA website’s Regulatory Testing webpage; scroll down about 70% of the way),

Science adviser Amy Clippinger has a Ph.D. in cellular and molecular biology and genetics and several years of research experience at the University of Pennsylvania.

PETA representatives have been to at least one other conference on the topic of nano, toxicology, and animal testing as per my April 24, 2014 posting about NANOTOX 2014 in Turkey,

Writing about nanotechnology can lead you in many different directions such as the news about PETA (People for the Ethical Treatment of Animals) and its poster presentation at the NanoTox 2014 conference being held in Antalya, Turkey from April 23 – 26, 2014. From the April 22, 2014 PETA news release on EurekAlert,

PETA International Science Consortium Ltd.’s nanotechnology expert will present a poster titled “A tiered-testing strategy for nanomaterial hazard assessment” at the 7th International Nanotoxicology Congress [NanoTox 2014] to be held April 23-26, 2014, in Antalya, Turkey.

Dr. Monita Sharma will outline a strategy consistent with the 2007 report from the US National Academy of Sciences, “Toxicity Testing in the 21st Century: A Vision and a Strategy,” which recommends use of non-animal methods involving human cells and cell lines for mechanistic pathway–based toxicity studies.

There is a lot of interest internationally in improving how we test for toxicity of nanomaterials. As well, the drive to eliminate or minimize as much as possible the use of animals in testing seems to be gaining momentum.

Good luck to everyone submitting a poster abstract and/or an application for a travel grant!

In case you don’t want to scroll up, the SRA nano workshop website is here.

Canada-US joint Regulatory Cooperation Council nanotechnology initiative completed and Canada endorses OECD nanomaterials recommendation

Thanks to Lynn Bergeson’s July 9, 2014 posting on Nanotechnology Now, I learned the Canada-US joint Regulatory Cooperation Council (RCC) nanotechnology initiative has completed its work and will be filing final reports later this summer (2014).

I have featured the RCC here in at least three postings, a Dec. 3, 2012 posting, a June 26, 2013 posting, and a January 21, 2014 posting. Briefly, the RCC was first announced in 2011 and is intended to harmonize Canadian and US regulatory frameworks in a number of areas including, agriculture and food, transportation, personal care products and pharmaceuticals and more. Significantly, nanotechnology was also part of their portfolio.

The latest information about RCC doings was obtained from the Canadian government’s 2014 summer issue of the Chemicals Management Plan (CMP) Progress Report (a second thank you for Bergeson for information about this publication),

The Canada-U.S. Regulatory Cooperation Council Nanotechnology Initiative is now complete. Canada and the U.S. are implementing the new approaches and lessons learned in risk assessments of nanomaterials. An important outcome of the initiative is the development of consistent policy principles on the regulatory oversight of nanomaterials, which have now been endorsed by the Government of Canada. Watch for the publication of the final reports from the Canada-U.S. Regulatory Cooperation Council Nanotechnology Initiative this summer. The reports will include recommendations about ways in which Canada and the U.S. can align their nanomaterial regulatory work, including the application of consistent risk assessment approaches and methodologies and identifying categories of nanomaterials.

The 2014 CMP summer issue offers a second tidbit of information. This time it’s about Canada and the OECD,

Canada has endorsed a recommendation from the Organisation for Economic Co-operation and Development’s Council on the Safety Testing and Assessment of Manufactured Nanomaterials. The recommendation states that countries “apply the existing international and national chemical regulatory frameworks or other management systems, adapted to take into account the specific properties of manufactured nanomaterials.” The recommendation was based on the work of the Organisation for Economic Co-operation and Development’s Working Party on Manufactured Nanomaterials, which is a harmonization effort to inform regulatory programs regarding the environmental and health and safety implications of manufactured nanomaterials.

For enthusiasts, Canada’s Chemicals Management Plan progress report is expected to be published twice/year. There are now two issues available, the first with a Dec. 30, 2013 publication date. Here’s more about the CMP progress reports,

The Chemicals Management Plan Progress Report has been created to keep stakeholders and other interested parties up to date on the activities and programs related to Canada’s Chemicals Management Plan (CMP). The report is produced jointly by Environment Canada and Health Canada and will be published twice a year. It will report on advances in major initiatives and highlight key activities related to the Government of Canada’s recent work under the CMP. It will also inform you about coming events, dates of interest and how to get involved.

We encourage you to share the reports with anyone who may be interested. We also welcome your feedback or suggestions. We can be reached at [email protected]

Anyone interested in more information about the RCC (Regulatory Cooperation Council) and its nanotechnology efforts can find it here.

An upcoming alternate testing strategies (ATS) for nanomaterials workshop and the quest to reduce animal testing

It’s too late to announce a call for poster abstracts or travel awards but that still leaves the possibility of attending a September 15-16, 2014 Workshop to Explore How a Multiple Models Approach can Advance Risk Analysis of Nanoscale Materials in Washington, DC. In a July 9, 2014 Nanowerk Spotlight article,, Jo Anne Shatkin (President, Vireo Advisors) and Lorraine Sheremeta (Assistant Director, Ingenuity Lab, University of Alberta) tout the workshop in the context of describing new approaches to nanotoxicology research (Note: A link has been removed),

Engineered nanoscale materials (ENM or ‘nanomaterials’) offer the potential to create safer and more effective products through the use of smaller quantities of improved performance materials. Currently nanomaterials are used to improve the performance of life-saving drugs and medical technologies, to make renewable energy more efficient, to make value added products from industrial waste streams, to improve food, packaging, to lightweight materials used in transportation systems, and to improve many of the personal care products that we use every day. Nanomaterial manufacture and use is expected to increase over the coming years and despite the widespread use of nanomaterials in a variety of consumer products, we are only beginning to understand the impacts of these emerging materials on our health and the environment. To this end, the University of Alberta’s Ingenuity Lab is collaborating with the Society for Risk Analysis to evaluate the potential to use alternative test strategies (ATS) to improve our ability to assess nanomaterial toxicity and environmental impact.

Shatkin and Sheremeta describe toxicology tests and explain the importance of refining and improving these tests (from the article),

Standard in vivo toxicology test methods that depend heavily on the use of animals have long been used to assess chemical safety. [emphasis mine*] Existing and novel in vitro and in silico test methods provide important alternatives to in vivo animal testing for chemicals and potentially for ENM. Genotoxicity tests, for example, are used to assess the mutagenic potential of chemicals or nanomaterials in the replication of DNA in cells. Driven in part by increasing market and regulatory requirements for safer and more sustainable products, large international infrastructure has developed for creating, testing and validating in vitro test methods, and its use is expanding to chemical and nanomaterial assessment (NSF, 2007). The goals of reducing, refining and replacing animal testing (the commonly cited ‘three Rs’) – resonate with key and diverse stakeholders including animal rights groups, the bioethics community, the pharmaceutical industry, regulatory agencies and the broader public. [emphasis mine*]

Despite nearly a decade of effort in the conduct toxicology and exposure research to inform the assessment of health and environmental risks of nanomaterials, major gaps remain in the ability to understand and quantify risks. While there is now a large body of published data on carbon nanotubes and metal oxide nanoparticles, concern has been raised that speculation about nanomaterial risk has hardened into an assumption that there are ‘as-yet-to-be-discovered risks’ that we must identify and manage (Maynard, 2014) that demands extensive testing.

The authors describe ATS (alternative test strategies) in greater detail,

ATS approaches are regarded by many to have the potential for rapid screening of large numbers and types of materials. They can include a breadth of techniques including high throughput screening methods (HTS), high content screening, computational approaches, toxicogenomics, cell-based methods, in vitro assays and non-mammalian whole animal models. The emergence of ATS raises questions about how the results of these methods may be used for assessing the potential risks of ENM. For instance, ATS could be used in combination in a multiple models approach to evaluate new ENM in a number of rapid assays and compare with well-studied substances using in vivo testing; thereby identifying ENM for additional testing in a more strategic fashion than is possible through conventional testing approaches.

They also describe the current state of affairs with ATS,

In the United States, the U.S. ToxCast program has, as part of their 21st century toxicity screening program (NRC, 2007), tested 29 NMs with 62 in vitro test methods (Wang et al. 2013). Many researchers, including several from the University of Alberta, have proposed and developed ATS to include a variety of methods, some which are standardized for chemicals, and others which take advantage of developments including advanced biological mechanistic understanding, genomics, metabolomics, automation and informatics. However, these existing as well as emerging ATS have a short history with nanomaterials, and have not yet proven to be reliable for quantitative estimation of ENM risk. Still, several international efforts have developed ATS that have potential to be used for screening purposes, and to guide further testing priorities for regulatory decision making. The goal of the September [2014] workshop by the Society for Risk Analysis is to explore ways in which distinct ATS may be used for screening and prioritizing the need for more extensive testing of novel ENM.

The parties (including the authors of the article) involved in developing this risk workshop are listed, also mentioned are members of the international testing scene,

Lori Sheremeta, the Assistant Director of Ingenuity Lab in Edmonton Alberta and past Chair of the Society for Risk Analysis (SRA) Emerging Nanoscale Materials Specialty Group (ENMSG), is collaborating with U.S.-based nanomaterials risk expert Jo Anne Shatkin (an SRA Councilor and co-founder of the SRA ENMSG), Environment Canada, Health Canada, the SRA ENMSG and others on a Pilot Project with the Organization for Economic Co-operation and Development (OECD) Working Party on Manufactured Nanomaterials (WPMN) to develop a report on the State of the Science for ATS for nanomaterials, catalogue of existing and emerging ATS methods in a database; and develop a case study to inform workshop deliberations and expert recommendations.

There are many international efforts to develop, as well as to validate and standardize, these methods for chemicals, including organizations such as the US National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (ICCVAM), the European Union Reference Laboratory European Centre for the Validation of Alternative Methods (EURL ECVAM), the Japanese Center for the Validation of Alternative Methods (JacVAM), the Korean Centre for the Validation of Alternative Methods (KoCVAM) and the OECD. There is wide recognition that the diversity of NMs renders it impractical to use traditional animal testing to evaluate safety, hence there is significant interest in assessing the performance of both existing and emerging alternative testing strategies for NMs. Further, the EU directive REACH (Directive 2006/121/EC) requires replacing in vivo testing, and there is widespread popular agreement about the desire to limit animal testing. Finally, there is a need for more biologically informative toxicology methods (Hartung, 2010; Silbergeld et al, 2011; Landsiedel et al, 2009).

A list of the workshop objectives is offered  in the article,

The main objectives of the workshop are to:

assess the state of the science on HTS and ATS from a ‘multiple models’ perspective to identify areas of common findings from differing approaches, areas of greatest uncertainty, and priorities for follow up in applied research toward risk assessment of ENM;
evaluate the ability to use data from ATS/HTS methods for screening purposes – combining suites of assays and comparing well-studied substances to novel ones;

assess the ability to use a suite of ATS methods to amplify the Weight of Evidence;

characterize uncertainty associated with predictive relationships and propose strategies to address uncertainties;

elicit the perspectives of diverse stakeholders about the use of HTS/ATS for screening purposes in risk analysis of ENM; and

develop a set of recommendations for these alternative approaches to become more widely adopted for environmental, health and safety decision making about ENM across the product life cycle. The output of the workshop holds potential for transformation through risk screening approaches that promote safer and more sustainable material and technology development.

You can find more about the September 15-16, 2014 Workshop to Explore How a Multiple Models Approach can Advance Risk Analysis of Nanoscale Materials in Washington, DC here.

The text in the article is a bit rough. Some of the ideas and topics don’t follow each other logically. So, be prepared to spend a little time reading, Happily, there are references included with the article.

I last mentioned Jo Anne Shatkin here in the context of a 2013 paper on alternative test strategies (ATS) in an Aug. 22, 2013 posting. I think the most recent mention of Lorraine Sheremeta here is in a Jan. 11, 2010 posting about Canada, nanotechnology, and food.

Final note, I am hoping to get some more information about the workshop and ATS scene from Lorraine Sheremeta to be published in a subsequent posting.

* I added the emphases at 0830 hours PDT July 10, 2014.

Does digitizing material mean it’s safe? A tale of Canada’s Fisheries and Oceans scientific libraries

As has been noted elsewhere the federal government of Canada has shut down a number of Fisheries and Oceans Canada libraries in a cost-saving exercise. The government is hoping to save some $440,000 in the 2014-15 fiscal year by digitizing, consolidating, and discarding the libraries and their holdings.

One would imagine that this is being done in a measured, thoughtful fashion but one would be wrong.

Andrew Nikiforuk in a December 23, 2013 article for The Tyee wrote one of the first articles about the closure of the fisheries libraries,

Scientists say the closure of some of the world’s finest fishery, ocean and environmental libraries by the Harper government has been so chaotic that irreplaceable collections of intellectual capital built by Canadian taxpayers for future generations has been lost forever.

Glyn Moody in a Jan. 7, 2014 post on Techdirt noted this,

What’s strange is that even though the rationale for this mass destruction is apparently in order to reduce costs, opportunities to sell off more valuable items have been ignored. A scientist is quoted as follows:

“Hundreds of bound journals, technical reports and texts still on the shelves, presumably meant for the garbage or shredding. I saw one famous monograph on zooplankton, which would probably fetch a pretty penny at a used science bookstore… anybody could go in and help themselves, with no record kept of who got what.”

Gloria Galloway in a Jan. 7, 2014 article for the Globe and Mail adds more details about what has been lost,

Peter Wells, an adjunct professor and senior research fellow at the International Ocean Institute at Dalhousie University in Halifax, said it is not surprising few members of the public used the libraries. But “the public benefits by the researchers and the different research labs being able to access the information,” he said.

Scientists say it is true that most modern research is done online.

But much of the material in the DFO libraries was not available digitally, Dr. Wells said, adding that some of it had great historical value. And some was data from decades ago that researchers use to determine how lakes and rivers have changed.

“I see this situation as a national tragedy, done under the pretext of cost savings, which, when examined closely, will prove to be a false motive,” Dr. Wells said. “A modern democratic society should value its information resources, not reduce, or worse, trash them.”

Dr. Ayles [Burton Ayles, a former DFO regional director and the former director of science for the Freshwater Institute in Winnipeg] said the Freshwater Institute had reports from the 1880s and some that were available nowhere else. “There was a whole core people who used that library on a regular basis,” he said.

Dr. Ayles pointed to a collection of three-ringed binders, occupying seven metres of shelf space, that contained the data collected during a study in the 1960s and 1970s of the proposed Mackenzie Valley pipeline. For a similar study in the early years of this century, he said, “scientists could go back to that information and say, ‘What was the baseline 30 years ago? What was there then and what is there now?’ ”

When asked how much of the discarded information has been digitized, the government did not provide an answer, but said the process continues.

Today, Margo McDiarmid’s Jan. 30, 2014 article for the Canadian Broadcasting Corporation (CBC) news online further explores digitization of the holdings,

Fisheries and Oceans is closing seven of its 11 libraries by 2015. It’s hoping to save more than $443,000 in 2014-15 by consolidating its collections into four remaining libraries.

Shea [Fisheries and Oceans Minister Gail Shea] told CBC News in a statement Jan. 6 that all copyrighted material has been digitized and the rest of the collection will be soon. The government says that putting material online is a more efficient way of handling it.

But documents from her office show there’s no way of really knowing that is happening.

“The Department of Fisheries and Oceans’ systems do not enable us to determine the number of items digitized by location and collection,” says the response by the minister’s office to MacAulay’s inquiry. [emphasis mine]

The documents also that show the department had to figure out what to do with 242,207 books and research documents from the libraries being closed. It kept 158,140 items and offered the remaining 84,067 to libraries outside the federal government.

Shea’s office told CBC that the books were also “offered to the general public and recycled in a ‘green fashion’ if there were no takers.”

The fate of thousands of books appears to be “unknown,” although the documents’ numbers show 160 items from the Maurice Lamontagne Library in Mont Jolie, Que., were “discarded.”  A Radio-Canada story in June about the library showed piles of volumes in dumpsters.

And the numbers prove a lot more material was tossed out. The bill to discard material from four of the seven libraries totals $22,816.76

Leaving aside the issue of whether or not rare books were given away or put in dumpsters, It’s not confidence-building when the government minister can’t offer information about which books have been digitized and where they might located online.

Interestingly,  Fisheries and Oceans is not the only department/ministry shutting down libraries (from McDiarmid’s CBC article),

Fisheries and Oceans is just one of the 14 federal departments, including Health Canada and Environment Canada, that have been shutting physical libraries and digitizing or consolidating the material into closed central book vaults.

I was unaware of the problems with Health Canada’s libraries but Laura Payton’s and Max Paris’ Jan. 20, 2014 article for CBC news online certainly raised my eyebrows,

Health Canada scientists are so concerned about losing access to their research library that they’re finding workarounds, with one squirrelling away journals and books in his basement for colleagues to consult, says a report obtained by CBC News.

The draft report from a consultant hired by the department warned it not to close its library, but the report was rejected as flawed and the advice went unheeded.

Before the main library closed, the inter-library loan functions were outsourced to a private company called Infotrieve, the consultant wrote in a report ordered by the department. The library’s physical collection was moved to the National Science Library on the Ottawa campus of the National Research Council last year.

“Staff requests have dropped 90 per cent over in-house service levels prior to the outsource. This statistic has been heralded as a cost savings by senior HC [Health Canada] management,” the report said.

“However, HC scientists have repeatedly said during the interview process that the decrease is because the information has become inaccessible — either it cannot arrive in due time, or it is unaffordable due to the fee structure in place.”

….

The report noted the workarounds scientists used to overcome their access problems.

Mueller [Dr. Rudi Mueller, who left the department in 2012] used his contacts in industry for scientific literature. He also went to university libraries where he had a faculty connection.

The report said Health Canada scientists sometimes use the library cards of university students in co-operative programs at the department.

Unsanctioned libraries have been created by science staff.

“One group moved its 250 feet of published materials to an employee’s basement. When you need a book, you email ‘Fred,’ and ‘Fred’ brings the book in with him the next day,” the consultant wrote in his report.

“I think it’s part of being a scientist. You find a way around the problems,” Mueller told CBC News.

Unsanctioned, underground libraries aside, the assumption that digitizing documents and books ensures access is false.  Glyn Moody in a Nov. 12, 2013 article for Techdirt gives a chastening example of how vulnerable our digital memories are,

The Internet Archive is the world’s online memory, holding the only copies of many historic (and not-so-historic) Web pages that have long disappeared from the Web itself.

Bad news:

This morning at about 3:30 a.m. a fire started at the Internet Archive’s San Francisco scanning center.

Good news:

no one was hurt and no data was lost. Our main building was not affected except for damage to one electrical run. This power issue caused us to lose power to some servers for a while.

Bad news:

Some physical materials were in the scanning center because they were being digitized, but most were in a separate locked room or in our physical archive and were not lost. Of those materials we did unfortunately lose, about half had already been digitized. We are working with our library partners now to assess.

That loss is unfortunate, but imagine if the fire had been in the main server room holding the Internet Archive’s 2 petabytes of data. Wisely, the project has placed copies at other locations …

That’s good to know, but it seems rather foolish for the world to depend on the Internet Archive always being able to keep all its copies up to date, especially as the quantity of data that it stores continues to rise. This digital library is so important in historical and cultural terms: surely it’s time to start mirroring the Internet Archive around the world in many locations, with direct and sustained support from multiple governments.

In addition to the issue of vulnerability, there’s also the issue of authenticity, from my June 5, 2013 posting about science, archives and memories,

… Luciana Duranti [Professor and Chair, MAS {Master of Archival Studies}Program at the University of British Columbia and Director, InterPARES] and her talk titled, Trust and Authenticity in the Digital Environment: An Increasingly Cloudy Issue, which took place in Vancouver (Canada) last year (mentioned in my May 18, 2012 posting).

Duranti raised many, many issues that most of us don’t consider when we blithely store information in the ‘cloud’ or create blogs that turn out to be repositories of a sort (and then don’t know what to do with them; ça c’est moi). She also previewed a Sept. 26 – 28, 2013 conference to be hosted in Vancouver by UNESCO (United Nations Educational, Scientific, and Cultural Organization), “Memory of the World in the Digital Age: Digitization and Preservation.” (UNESCO’s Memory of the World programme hosts a number of these themed conferences and workshops.)

The Sept. 2013 UNESCO ‘memory of the world’ conference in Vancouver seems rather timely in retrospect. The Council of Canadian Academies (CCA) announced that Dr. Doug Owram would be chairing their Memory Institutions and the Digital Revolution assessment (mentioned in my Feb. 22, 2013 posting; scroll down 80% of the way) and, after checking recently, I noticed that the Expert Panel has been assembled and it includes Duranti. Here’s the assessment description from the CCA’s ‘memory institutions’ webpage,

Library and Archives Canada has asked the Council of Canadian Academies to assess how memory institutions, which include archives, libraries, museums, and other cultural institutions, can embrace the opportunities and challenges of the changing ways in which Canadians are communicating and working in the digital age.

Background

Over the past three decades, Canadians have seen a dramatic transformation in both personal and professional forms of communication due to new technologies. Where the early personal computer and word-processing systems were largely used and understood as extensions of the typewriter, advances in technology since the 1980s have enabled people to adopt different approaches to communicating and documenting their lives, culture, and work. Increased computing power, inexpensive electronic storage, and the widespread adoption of broadband computer networks have thrust methods of communication far ahead of our ability to grasp the implications of these advances.

These trends present both significant challenges and opportunities for traditional memory institutions as they work towards ensuring that valuable information is safeguarded and maintained for the long term and for the benefit of future generations. It requires that they keep track of new types of records that may be of future cultural significance, and of any changes in how decisions are being documented. As part of this assessment, the Council’s expert panel will examine the evidence as it relates to emerging trends, international best practices in archiving, and strengths and weaknesses in how Canada’s memory institutions are responding to these opportunities and challenges. Once complete, this assessment will provide an in-depth and balanced report that will support Library and Archives Canada and other memory institutions as they consider how best to manage and preserve the mass quantity of communications records generated as a result of new and emerging technologies.

The Council’s assessment is running concurrently with the Royal Society of Canada’s expert panel assessment on Libraries and Archives in 21st century Canada. Though similar in subject matter, these assessments have a different focus and follow a different process. The Council’s assessment is concerned foremost with opportunities and challenges for memory institutions as they adapt to a rapidly changing digital environment. In navigating these issues, the Council will draw on a highly qualified and multidisciplinary expert panel to undertake a rigorous assessment of the evidence and of significant international trends in policy and technology now underway. The final report will provide Canadians, policy-makers, and decision-makers with the evidence and information needed to consider policy directions. In contrast, the RSC panel focuses on the status and future of libraries and archives, and will draw upon a public engagement process.

So, the government is shutting down libraries in order to save money and they’re praying (?) that the materials have been digitized and adequate care has been taken to ensure that they will not be lost in some disaster or other. Meanwhile the Council of Canadian Academies is conducting an assessment of memory institutions in the digital age. The approach seems to backwards.

On a more amusing note, Rick Mercer parodies at lease one way scientists are finding to circumvent the cost-cutting exercise in an excerpt (approximately 1 min.)  from his Jan. 29, 2014 Rick Mercer Report telecast (thanks Roz),

Mercer’s comment about sports and Canada’s Prime Minister, Stephen Harper’s preferences is a reference to Harper’s expressed desire to write a book about hockey and possibly a veiled reference to Harper’s successful move to prorogue parliament during the 2010 Winter Olympic games in Vancouver in what many observers suggested was a strategy allowing Harper to attend the games at his leisure.

Whether or not you agree with the decision to shutdown some libraries, the implementation seems to have been a remarkably sloppy affair.

Canada-US Regulatory Cooperation Council’s Nanotechnology Work Plan

Thanks for Lynn L. Bergeson for her Dec. 1, 2012 posting on the Nanotechnology Now website for the information about a Nov. 28, 2012 webinar that was held to discuss a Nanotechnology Work Plan developed by the joint Canada-US Regulatory Cooperation Council (or sometimes it’s called the US-Canada Regulatory Cooperation Council),

The RCC requested that industry provide more information on the commercial distribution of nanomaterials, as well as more transparency by claiming confidentiality of only that information absolutely critical to market advantage.

To compare risk assessment and risk management practices to highlight and identify best practices, data gaps, and differences between the two jurisdictions, the RCC sought nominations of a nanomaterial substance for a case study. Four nanomaterial substances were nominated: multiwall carbon nanotubes, nanocrystalline cellulose, nano silver, and titanium dioxide. The RCC has selected multiwall carbon nanotubes for the case study. The RCC intends to hold in March 2013 a workshop in Washington, D.C., to discuss information collected to date and approaches moving forward. In spring 2013, the RCC will hold one or two conference calls or webinars to discuss information gathered between countries and the path forward. Finally, in fall 2013, the RCC expects to hold a stakeholder consultation/workshop on results to date.

Here’s some background on the RCC. First announced in February 2011, the RCC had its first ‘stakeholder’ session (attended by approximately 240)  in January 2012 in Washington, DC. where a series of initiatives, including nanotechnology, were discussed (from the US International Trade Administration RCC Stakeholder Outreach webpage),

Agriculture and Food, Session A

  • Perimeter approach to plant protection

Agriculture and Food, Session B

  • Crop protection products

Agriculture and Food, Session C

  • Meat/poultry – equivalency
  • Meat/poultry – certification requirements
  • Meat cut nomenclature

Agriculture and Food, Session D

  • Veterinary drugs
  • Zoning for foreign animal disease

Agriculture and Food, Session E

  • Financial protection to produce sellers

Agriculture and Food, Session F

  • Food safety – common approach
  • Food safety – testing

Road Transport – Motor Vehicles

  • Existing motor vehicle safety standards
  • New motor vehicle safety standards

Air Transport

  • Unmanned aircraft

Transportation

  • Intelligent Transportation Systems

Transportation

  • Dangerous goods means of transportation

Marine Transport

  • Safety and security framework & arrangement for the St. Lawrence Seaway & Great Lakes System
  • Marine transportation security regulations
  • Recreational boat manufacturing standards
  • Standard for lifejackets

Rail Transport

  • Locomotive Emissions
  • Rail Safety Standards

Environment

  • Emission standards for light-duty vehicles

Personal Care Products & Pharmaceuticals

  • Electronic submission gateway
  • Over-the-counter products – common monographs
  • Good manufacturing practices

Occupational Safety Issues

  • Classification & labelling of workplace hazardous chemicals

Nanotechnology

  • Nanotechnology

Led jointly by senior officials from Canada and the United States, the purpose of the various technical review sessions was to seek expert advice and technical input from the approximately 240 stakeholders in attendance.

Since the Jan. 2012 meeting, a Nanotechnology Work Plan has been developed and that’s what was recently discussed at the Nov. 28, 2012 webinar. I did find more on a Canadian government website, Canada’s Economic Action Plan Nanotechnology Work Plan webpage,

Nanotechnology Work Plan

 Canada Leads: Karen Dodds, Assistant Deputy Minister, Science and Technology Branch, Environment Canada (EC)

Hilary Geller, Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch, Health Canada (HC)

U.S. Lead: Margaret Malanoski, Office of Information and Regulatory Affairs, Office of Management and Budget

Deliverable Outcome: Share information and develop common approaches, to the extent possible, on foundational regulatory elements, including criteria for determining characteristics of concern/no concern, information gathering, approaches to risk assessment and management, etc. Develop joint initiatives to align regulatory approaches in specific areas such that consistency exists for consumers and industry in Canada and the US.

Principles: Identification of common principles for the regulation of nanomaterials to help ensure consistency for industry and consumers in both countries

3-6 months:

Canada provides initial feedback on US “Policy Principles for the US Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials”.

6-12 months:

Countries complete an initial draft of shared principles for the regulation of nanomaterials.

12-18 months:

Update of draft principles informed from on-going stakeholder and expert consultations.

18th month:

Stakeholder consultation / workshop on results to date and future ongoing engagement.

Beyond 18 months:

Countries complete final draft of shared principles for the regulation of nanomaterials.

Workplan for Industrial Nanomaterials

Priority-Setting: Identify common criteria for determining characteristics of industrial nanomaterials of concern/no-concern

1-3 months:

  1. Define and finalize workplan (1st month)
  2. Develop mechanisms for stakeholder outreach and engagement (1st month)
  3. Conference call with relevant stakeholders to share and discuss workplan and call for Industry to volunteer nanomaterials for joint CAN/US review

3-6 months:

Share available scientific evidence regarding characteristics of industrial nanomaterials including that obtained from existing international fora (e.g. OECD Working Party on Manufactured Nanomaterials [Canada is a lead in the OECD Working Party on Manufactured Nanomaterials]).

8th month:

Stakeholder workshop to discuss information collected to date and approaches moving forward.

6-12 months:

Initiate an analysis of characteristics of select nanomaterials: similarities, differences, reasons for them.

Initiate discussions on approaches to consider for common definitions and terminology.

12th month:

Second conference call with relevant stakeholders to discuss non-CBI information gathered between the Countries and to discuss path forward in terms of development of reports and analyses.

12-18 months:

Develop draft criteria for determining characteristics of industrial nanomaterials of concern/no-concern.

15th month:

Third conference call with relevant stakeholders to discuss progress and to prepare for the upcoming stakeholder consultation/workshop.

Here’s information for the leads should you feel compelled to make contact,

Canada

(Lead) Karen Dodds, Assistant Deputy Minister, Science and Technology, Environment Canada ([email protected]; ph. 613- 819-934-6851)

Hilary Geller, Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch ([email protected]; ph. 613-946-6701)

United States

(Lead) Margaret Malanoski, Office of Management and Budget ([email protected])

I gather that the ‘stakeholders’ are business people, researchers, and policy analysts/makers as there doesn’t seem to be any mechanism for public consultation or education, for that matter.

Trent University (Ontario, Canada) and nanosilver toxicology studies

One of the scientists on a research team at Trent University (Ontario, Canada) is claiming that safety questions about nanomaterials are not being asked and so the team is embarking on a study of silver nanoparticles and their impact on a lake ecosystem. From the May 2, 2012 news item on Nanowerk,

Dr. Chris Metcalfe, professor and director of the Institute for Watershed Science at Trent University, is the principal investigator on the Lake Ecosystem Nanosilver (LENS) project with Trent researchers, Drs. Maggie Xenopoulos, Holger Hintelmann and Paul Frost, and colleagues from Fisheries and Oceans Canada and Environment Canada.

“This is a high profile project that will have the eyes of the scientific community on Trent,” said Professor Metcalfe. “We’re fortunate that we have four world-class researchers on our team.” Over the past decade, tiny substances called nanomaterials have become part of our daily lives.

It’s possible that the clothes you’re wearing, or the sunscreen you just applied, contain nanomaterials. Because of this growing use, there is now concern that nanomaterials may pose threats to the environment.

“We have seen an exponential growth in the use of nanomaterials,” said Professor Xenopoulos, an associate professor in the Biology department at Trent University. “However, questions of safety are not being asked.” [emphasis mine]

Likely the claim is a little overenthusiasm or a lack of clarity on the speaker’s part since there has been more than one study about nanosilver particles and safety, including one at Purdue University mentioned in a March 4, 2010 posting on the Beyond Pesticides blog. The Purdue study (The effects of silver nanoparticles on fathead minnow (Pimephales promelas) embryos) is behind a paywall.

Here’s a bit more about silver nanoparticles and the LENS study,

While the benefits of nanomaterials are recognized, we know little about their risks to health and the environment. Due to their extremely small size, nanomaterials interact with cells and organic molecules, raising questions about their impact on organisms.

Due to their antibacterial properties, nanosilver particles are among the most widely-used nanomaterials in consumer goods. Clothing, home appliances, paint, bandages and food storage containers are a few of the products which may contain nanosilver. As we use and dispose of these products, there is a risk that nanosilvers will travel through our municipal water systems into our lakes and rivers.

The research team is working to understand the effect of nanosilver particles on the aquatic environment. Initial laboratory research conducted at Trent indicates that nanosilver can strongly affect aquatic organisms at the bottom of the food chain, such as bacteria, algae and zooplankton.

To further examine these effects in a real ecosystem, the team is conducting a study at the Experimental Lakes Area, near Kenora, in northwestern Ontario.

The LENS project will monitor changes in a lake’s ecosystem that occur after the addition of nanosilver. It will follow nanosilver as it travels through the lake ecosystem, track effects through the entire food web, and determine how resulting changes alter ecosystem function.

There’s more about the LENS project on the Trent University LENS (Lake Ecosystem Nanosilver) Project page (excerpt),

Our previous laboratory research has shown that nanosilver in the aquatic environment first affect organisms at the bottom of the food chain, including bacteria, algae and zooplankton. These responses may have devastating effects upon aquatic ecosystems by reducing overall productivity and altering the cycling of nutrients, such as carbon, nitrogen and phosphorus. There may be compensatory mechanisms within aquatic ecosystems that can mitigate these responses, but it is impossible to predict these responses using laboratory studies. Through support from the Strategic Grants Program of the Natural Sciences and Engineering Research Council of Canada and Environment Canada, a team of researchers from Trent University, Environment Canada and Fisheries and Oceans Canada will conduct a study at the Experimental Lakes Area (ELA) in northwestern Ontario by adding nanoform silver to a small lake over two summer field seasons ion 2013-14. During nano-silver additions, we will monitor the lake for changes to nutrient cycling and the biological effects within the entire food chain. However, in 2012, before starting the lake additions, we will refine our approach by determining what happens in mesocosms (i.e. plastic tubes) that are deployed in lakes. ELA has been used for over 40 years as a living laboratory to study the effects of pollutants in the environment, including past studies of the impacts of pollution from phosphorus, acid deposition, mercury and endocrine disruptors. These studies have resulted in policies to reduce the impacts of pollution. While we do not take lightly the impact that this study will have upon a lake in ELA, this approach is the only way to determine ecosystem level impacts and to influence regulatory policy regarding the ecological risks of NMs.

This is a three-year project, which starts this year (2012).

One more muzzle for Canadian government scientists

It’s a wee bit puzzling as to why government scientist (Natural Resources Canada), Scott Dallimore had to get permission from the minister before talking to journalists about his co-authored study featuring a flood in northern Canada that took place 13,000 years ago. From the article by Margaret Munro for PostMedia News on canada.com (ETA Jan. 6, 2014: Munro’s article seems to have been removed for all the news sites but it  can be found on her own blog here.)

NRCan [Natural Resources Canada] scientist Scott Dallimore co-authored the study, published in the journal Nature on April 1, about a colossal flood that swept across northern Canada 13,000 years ago, when massive ice dams gave way at the end of the last ice age.

The study was considered so newsworthy that two British universities issued releases to alert the international media.

It was, however, deemed so sensitive in Ottawa that Dallimore, who works at NRCan’s laboratories outside Victoria, was told he had to wait for clearance from the minister’s office.

Dallimore tried to tell the department’s communications managers the flood study was anything but politically sensitive. “This is a blue sky science paper,” he said in one email, noting: “There are no anticipated links to minerals, energy or anthropogenic climate change.”

But the bureaucrats in Ottawa insisted. “We will have to get the minister’s office approval before going ahead with this interview,” Patti Robson, the department’s media relations manager, wrote in an email after a reporter from Postmedia News (then Canwest News Service) approached Dallimore.

Robson asked Dallimore to provide the reporter’s questions and “the proposed responses,” saying: “We will send it up to MO (minister’s office) for approval.” Robson said interviews about the flood study needed ministerial approval for two reasons: the inquiring reporter represented a “national news outlet” and the “subject has wide-ranging implications.”

At this point Environment Canada and Health Canada have similar rules in place for their scientists and any potential media interviews. I have commented on a similar situation previously in my Sept. 21 2009 posting, which includes a link to an earlier story by Margaret Munro about Environment Canada and its gag order.

I gather the scientists can discuss the gag order without recourse to the ‘Minister’s Office’, they just can’t discuss their own work. That seems rather odd especially in light of a government that loves to trumpet its investment in science. If the public never gets to hear about the exciting discoveries that our publicly funded scientists are making, how can the government expect to get support for its science spending policies?

Regulating nanomaterials according to the US GAO and EPA

It’s been a banner week for information about nanomaterials regulation. As I noted yesterday, the US General Accountability Office has just released its  report titled Nanotechnology: Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk. Hats off to the authors: Anu Mittal, lead author, and Elizabeth Erdmann, David Bennett, Antoinette Capaccio, Nancy Crothers, Cindy Gilbert, Gary Guggolz, Nicole Harkin, Kim Raheb, and Hai Tran.

In discussing some of the oversight and regulatory issues associated with nanotechnology and other emerging technologies they had this to say (from the report),

Nanotechnology is an example of a fast-paced technology that poses challenges to agencies’ policy development and foresight efforts. We have conducted past work looking at the challenges of exercising foresight when addressing potentially significant but somewhat uncertain trends,5 including technology-based trends that proceed at a high “clockspeed,” that is, a (1) faster pace than trends an agency has dealt with previously or (2) quantitative rate of change that is either exponential or exhibits a pattern of doubling or tripling within 3 or 4 years, possibly on a repeated basis.6 As our prior work has noted, when an agency responsible for ensuring safety faces a set of potentially significant high-clockspeed technology-based trends, it may successfully exercise foresight by carrying out activities such as

• considering what is known about the safety impact of the trend and deciding how to respond to it;

• reducing uncertainty as needed by developing additional evidence about the safety of the trend; and

• communicating with Congress and others about the trends, agency responses, and policy implications.

Similarly, our 21st Century Challenges report raised concern about whether federal agencies are poised to address fast-paced technology-based challenges. [GAO, 21st Century Challenges: Reexamining the Base of the Federal Government, GAO-05-325SP (Washington, D.C.: February 2005)] Other foresight literature illustrates the potential future consequences of falling behind a damaging trend that could be countered by early action. These analyses suggest that unless agencies and Congress can stay abreast of technological changes, such as nanotechnology, they may find themselves “in a constant catch-up position and lose the capacity to shape outcomes.” (p.7/8 print version, p. 11/2 PDF)

(Seems to me the Canadian government could also do with some thoughtful consideration of fast-changing technologies and the challenges they pose to the institutional oversight mechanisms currently in place.)

The report goes on to describe various nano-enabled product categories in various industry sectors. It’s an overview that includes products (e.g. nano-enabled cell phones) currently or soon-to-be on the market. I was particularly taken with an image of a cell phone  that tagged parts  already nano-enabled (on some models) along with parts that may, in the future, become nano-enabled (p. 14 print version or p. 18 PDF).

The toxicity roundup is one of the best presentations I’ve seen. For example,

  • Size. Research assessing the role of particle size on toxicity has generally found that some nanoscale (<100 nanometers) particles are more toxic and can cause more inflammation than conventionally scaled particles of the same composition. Specifically, some research indicates that the toxicity of certain nanomaterials, such as some forms of carbon nanotubes and nanoscale titanium dioxide, may pose a risk to human health because these materials, as a result of their small size, may be able to penetrate cell walls, causing cell inflammation and potentially leading to certain diseases. For example, the small size of these nanomaterials may allow them to penetrate deeper into lung tissue, potentially causing more damage, according to some of the studies we reviewed. In addition, some nanomaterials may disperse differently into the environment than conventionally scaled materials of the same composition because of their size. However, according to EPA, the small particle size may also cause the nanomaterials to agglomerate, which may make it more difficult for them to penetrate deep lung tissue. (pp. 23/4 print version, pp. 27/8 PDF)

This a much more measured but still cautious approach to the toxicology issues as they relate to size and this approach is maintained throughout.

There’s more than one way to be exposed,

In addition to toxicity, the risk that nanomaterials pose to humans and the environment is also affected by the route and extent of exposure to such materials. Nanomaterials can enter the human body through three primary routes: inhalation, ingestion, and dermal penetration. (p. 25 print version, p. 29 PDF)

They also make the distinction between exposure as a consequence of consuming products and exposure due to occupation.

Moving on from toxicity, their section on the international scene wowed me because this is the only report I’ve seen which notes that Canada’s nanomaterials inventory has yet to occur.

One thing I hadn’t realized was how similar Environment Canada’s and the US Environmental Protection Agency’s approach to nanomaterials has been. From my April 2, 2010 posting,

Here’s what Environment Canada has to say about nanomaterials (the information on this page is dated from 2007 …) NOTE: The page originally cited is no longer available, go to this page,

The Domestic Substances List (DSL) is the sole basis for determining whether a substance is new. Any chemical or polymer not listed on the DSL is considered to be new to Canada and is subject to the notification requirements under the Regulations. Substances listed on the DSL do not require notification1 in advance of manufacture in or import into Canada.

The Act and the Regulations apply to new nanomaterials just as any other substance, whether a chemical or a polymer.

Substances listed on the DSL whose nanoscale forms do not have unique structures or molecular arrangements are considered existing. Existing nanomaterials are not subject to the Regulations and do not require notification. For example, titanium dioxide [emphasis mine] (CAS No. 13463-67-7) is listed on the DSL and since its nanoscale form does not have unique structures or molecular arrangements, it is not subject to the Regulations.

Compare,

In its 2008 document, EPA stated that a nanomaterial is a new chemical for purposes of regulation under TSCA only if it does not have the same “molecular identity” as a chemical already on the inventory. Under TSCA, a chemical is defined in terms of its particular molecular identity.

Thus, because titanium dioxide is already listed on the TSCA inventory, nanoscale versions of titanium dioxide, which have the same molecular formula, would not be considered a new chemical under TSCA, despite having a different size or shape, different physical and chemical properties, and potentially different risks. [emphasis mine] (p. 34 print version, p. 38 PDF)

I gather the EPA adopted the strategy one year after Environment Canada. Given how often the various jurisdictions copy each other’s approaches, I wonder which country (or possibly a jurisdiction such as the European Commission) actually set this strategy.

The report offers an excellent summary of Canada’s current regulatory approach and plans. I’ve reproduced the passage in full here,

Canadian officials have proposed but have not implemented a one-time requirement for companies to provide information on nanomaterials produced in or imported into Canada. Canadian importers and manufacturers would be required to report their use of nanomaterials produced or imported in excess of 1 kilogram. In 2009, Canadian officials reported to the OECD that information required would include chemical and trade name; molecular formula; and any available information on the shape, size range, structure, quantity imported or manufactured, and known or predicted uses. Also required would be any available information on the nanomaterial’s physical and chemical properties—such as solubility in water and toxicological data, among others. Under the proposal, companies could claim information as confidential, but regulators would publish a summary of information provided. Canada plans to use this information to help develop a regulatory framework for nanomaterials and to determine which information requirements would be useful for subsequent risk assessments. Canadian officials stated they originally hoped to issue this requirement in the spring of 2009 but could not predict when it would be implemented.

With regard to current law, a report prepared for the government of Canada in 2008 stated that Canada has no specific requirements for nanomaterials and is considering whether they are needed. However, Health Canada and Environment Canada—two agencies responsible for health and the environment—have taken the first steps in recognizing the potentially unique aspects of nanomaterials. These regulatory agencies are currently relying on existing authority delegated to them through legislation, such as the Canadian Environmental Protection Act, to address nanomaterials. Specifically, in June 2007, Environment Canada released a new substances program advisory announcing that nanomaterials will be regulated under the act’s new substances notification regulations. Per this advisory, any nanomaterial not listed on Canada’s chemical inventory—the Domestic Substances List—or with “unique structures or molecular arrangements” compared to their non-nano counterparts, requires a risk assessment. A review panel of the Canadian Academies found that, while it is not necessary to create new regulatory mechanisms to address the unique challenges presented by nanomaterials, the existing regulatory mechanisms could and should be strengthened in a variety of ways, such as by creating a specific classification for nanomaterials and by reviewing the regulatory triggers that prompt review of the health and environmental effects. (pp. 45/6 print version, pp. 49/50 PDF)

As far as I’m aware, there are no comparable summaries available in Canadian reports available to the public. No doubt there are nits to be picked but all I can say is thank you for giving me the most comprehensive and succinct overview I’ve seen yet of the emerging Canadian regulatory framework for nanomaterials.

For interested parties, there is some additional information about Health Canada’s public consultation on their interim definition of nanomaterials in my April 28, 2010 posting.