Tag Archives: Interim policy statement on Health Canada’s Working Definition for Nanomaterials

Health Canada publishes results of public consultation on Policy Statement on Health Canada’s Working Definition for Nanomaterials!

Hot off the email.  I received notice, about 60 mins. ago, that the results of the March – August 2010 public consultation on Health Canada’s Policy Statement on Health Canada’s Working Definition for Nanomaterials. From my Oct. 11, 2011 email,

In March 2010, Health Canada launched a web-based consultation on the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials.  The consultation was open for comment from March 1 to August 31, 2010.  During that period, Health Canada received a total of 29 submissions from companies, industry groups, governments, academia, public interest groups and interested citizens.

Health Canada made changes to the Interim Policy Statement based on stakeholders’ feedback.  Changes were also informed by developments in international norms, evolving scientific evidence and regulatory program needs.  These changes appear in the Policy Statement on Health Canada’s Working Definition for Nanomaterial which will continue to be updated as the body of scientific evidence and international norms progress.

Health Canada’s responses to key stakeholder comments are summarised in the following documents:

· Summary of Comments Received on the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials – March to August 2010

· Frequently Asked Questions Related to the Policy Statement on Health Canada’s Working Definition for Nanomaterial.

The Policy Statement, the Summary Report, and the Frequently Asked Questions are all now available on Health Canada’s website on the Science and Research webpage at http://www.hc-sc.gc.ca/sr-sr/pubs/nano/index-eng.php

Thank you to Laird Roe, A/Director General, Science Policy Directorate Strategic Policy Branch, and all of the other folks who’ve worked to get this published.

I have taken a very quick look at the updated website which no longer includes the word ‘interim’ with its title: Policy Statement on Health Canada’s Working Definition for Nanomaterial. It was made effective Oct. 6, 2011.

The changes made in response to submissions received as part of the public consultation are noted on the Summary of Comments Received on the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials – March to August 2010 page. Included is a list of the 29 respondents,

Companies:

  • DuPont Canada
  • Hogan Lovells International LLP
  • Johnson & Johnson Inc
  • Johnson & Johnson Medical Products
  • Logistik Unicorp
  • PerkinElmer Instruments

Industry Organizations

  • Canadian Apparel Federation
  • Canadian Association of Chemical Distributors
  • Canadian Consumer Specialty Products Association
  • Canadian Cosmetic, Toiletry and Fragrance Association
  • Canadian Manufacturers & Exporters
  • Canada’s Medical Technology Companies
  • Canada’s Research-Based Pharmaceutical Companies
  • Food & Consumer Products of Canada
  • Industry Coordinating Group for the Canadian Environmental Protection Act
  • The Nanotechnology Panel of the American Chemistry Council
  • The Society of the Plastics Industry, Inc.

Governments:

  • Ministry of Health, Government of British Columbia
  • Peel Public Health

Academia:

  • Centre des Nanomatériaux de l’Université du Québec à Montréal

Public Interest Groups:

  • Canadian Cancer Society
  • Canadian Environmental Law Association
  • Canadian Institute for Environmental Law and Policy

Media Blog:

  • FrogHeart.ca

Not sure I’d ever describe this as a media blog (obsession, maybe?) but to paraphrase the Scotsman Robbie Burns, it’s always interesting to see ourselves as others see us.

I’m sorry they didn’t post the individual submissions as they did for the Review of Federal Support to Research and Development as it would have interesting to see and compare the other submissions.

They did break down the comments in the various submissions,

Key comments provided fell into three categories:

  1. the Process of the creation of the working definition (how it was developed);
  2. the Content of the working definition (clarity/inclusion of key terms); and,
  3. the Application or use of the policy statement (clarifying the regulatory context).

This description of the categories is followed by a table which summarizes both the  comments and Health Canada’s responses (not reproduced here).

One of my key concerns, public engagement/discussion was not addressed either in the summary or on the FAQs (Frequently Asked Questions) page. I suggest looking at the FAQs page as there is some very interesting information there including the answer to this question,

8. Does Health Canada take a precautionary approach to nanomaterials?

Taking a precautionary approach is key to fostering the development and inclusion of new knowledge into decision making. The precautionary approach is part of the Canadian Environmental Protection Act, 1999, the Pest Control Products Act, and is referenced in the Canada Consumer Product Safety Act which will further support existing authorities to collect information regarding nanomaterial for the assessment of potential health risks and benefits.

Over the next few years, Health Canada will take an incremental approach to address regulatory, science and policy needs while allowing for the integration of new scientific evidence as it becomes available. Health Canada’s principle interest is in obtaining information that will improve the understanding of nanomaterials for risk assessment and risk management purposes.

I was much encouraged to see a flexible approach has been adopted as you can see in this example from the elaboration on the policy statement,

“Part a” of the Working Definition relates to current evidence suggesting that nanoscale properties/phenomena are more likely observable at the scale of 1-100 nanometres (more often at the lower end)5 and “Part b” reflects that it is possible for nanoscale properties/ phenomena to be exhibited outside this size range, such as select quantum devices6.

A variety of lexicons and interpretations of “nano-terminology” currently exist, underlining the importance of understanding the context in which these terms are used. In the risk assessment context supporting hazard and exposure assessment for risk characterization and management, the term “nanoscale properties/phenomena” refers to size-related properties which have qualities or characteristics that do not readily extrapolate from those observed in individual atoms, molecules or bulk materials. For example, “bulk” gold is not very reactive, but nanoscale gold can act as a chemical catalyst2. For risk assessment purposes, this term includes observable biological or environmental effects resulting from size-related properties as described above. Examples of such biological or environmental effects could be increased permeability through cell membranes8 or increased reactivity of iron/iron oxides for the purposes of groundwater remediation9, respectively.

So there you have it a few nits to pick and a few roses to give. I trust and hope that there will be more commentary from other sources over the coming days.

In March 2010, Health Canada launched a web-based consultation on the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials.  The consultation was open for comment from March 1 to August 31, 2010.  During that period, Health Canada received a total of 29 submissions from companies, industry groups, governments, academia, public interest groups and interested citizens.

Health Canada made changes to the Interim Policy Statement based on stakeholders’ feedback.  Changes were also informed by developments in international norms, evolving scientific evidence and regulatory program needs.  These changes appear in the Policy Statement on Health Canada’s Working Definition for Nanomaterial which will continue to be updated as the body of scientific evidence and international norms progress.

Health Canada’s responses to key stakeholder comments are summarised in the following documents:

· Summary of Comments Received on the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials – March to August 2010

Frequently Asked Questions Related to the Policy Statement on Health Canada’s Working Definition for Nanomaterial.

The Policy Statement, the Summary Report, and the Frequently Asked Questions are all now available on Health Canada’s website on the Science and Research webpage at http://www.hc-sc.gc.ca/sr-sr/pubs/nano/index-eng.php

Nanomaterials, nanomedicines and nanodefinitions

I was chatting earlier this week, in the most general way possible, with someone in Ottawa about nanotechnology and regulations.  The individual noted that nanotechnology initiatives in various countries and regions are attaining traction and I think the evidence is in the increased (and heated) discussion/debate about defining nanomaterials. The latest twist in the discussion comes from Alok Jha, a science writer for The Guardian. In his Sept. 6, 2011 article, Nanotechnoglogy world: Nanomedicine offers new cures, he tackles the topic from the nanomedicine perspective.

The EU ObservatoryNano organisation, which supports European policy makers through scientific and economic analysis of nanoscience and nanotechnology developments, produced a report on the ethics of nanotechnology written by Ineke Malsch, director of Malsch TechnoValuation. She says the problem with regulating medical nanotechnology can be how to define a product’s area of application. “The distinction between a medical device and a pharmaceutical is quite fuzzy. …”

How do you regulate a drug-releasing implant, for example? Is Cuschieri’s nano-carrier a pharmaceutical or a medical device? One of [the] key issues, says Malsch, is that there is the lack of common agreement or definition, at the international level, of what a nanoparticle is and what constitutes nanomedicines. “There is continuing discussion about these definitions which will hopefully be resolved before the end of the year.”

Current regulations are more than enough for current technologies, says Malsch, but she adds that this will need to be kept under review. But over-regulating now would also be a mistake. Pre-empting (and trying to pre-regulate) technology that does not yet exist is not a good idea, she says.

This view was backed up by Professor Andrew Maynard, the director of the Risk Science Centre, who says: “With policy-makers looking for clear definitions on which to build ‘nano-regulations’, there is a growing danger of science being pushed aside.”

This (the fuzzy distinction between a pharamaceutical and a medical device) certainly adds a new twist to the debate for me.

Also, I should note that this article’s banner says: Nanotechnology world, in association with Nano Channels.Tim Harper (Cientifica and TNTlog) noticed in an earlier Guardian article on nanotechnology (from his July 7, 2011 posting),

My delight at seeing a sensible piece about “nanotechnology in everyday life” by Colin Stuart (@skyponderer) published in the Guardian Newspaper turned to puzzlement when I noticed that the article was “Paid for by NanoChannels.”

There seems to be some distinction between “paid for” and “in association with,” but I can’t confirm that at this time. Now back to the topic.

In my August 31, 2011 posting, I noted the latest salvo from Hermann Stamm, of the European Commission Joint Research Centre, Institute for Health and Consumer Protection where he reiterated that a hard and fast definition based on size is the best choice. In his Sept. 6, 2011 posting, Andrew where he expands on a concern (i. e. policymakers will formulate a definition not based on scientific data but based on political pressures and/or public relations worries) that I’ve given short shrift. From his Sept. 6, 2011 posting,

And despite policy makers repeatedly stating that any form of nanomaterial regulation should be science-based, I have the sense that they are scrambling to use science to justify a predetermined conclusion – that engineered nanomaterials should be regulated on the basis of a hard and fast definition – rather than using science to guide their actions.Instead, I would suggest that we need to put aside preconceptions of what is important and what is not here, and start by asking how new generations of sophisticated (or advanced) materials interact with biological systems; where these interactions have the potential to cause harm in ways not captured within current regulatory frameworks; and how these frameworks can be adapted or altered to ensure that an increasing number of unusual substances are developed and used as safely as possible – no matter what label or “brand” is applied to them.

He was a little more explicit about what he thinks are the reasons behind this preference for a “hard and fast definition” in his April 15, 2011 posting,

Sadly, it now looks like we are heading toward a situation where the definitions of nanomaterials underpinning regulations will themselves be based on policy, not science.

This scares the life out of me, because it ends up taking evidence off the table when it comes to oversight, and replacing it with assumptions and speculation on what people think is relevant, rather than what actually is – not good for safety, and certainly not good for business.

 

All this got me to thinking about the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials and the public consultation which ended August 31, 2010.  According to the website, we will be learning the results of the consultation,

Reporting to Canadians

Health Canada will make the results of this consultation available on this Web site.  Health Canada will take further steps to illustrate how the policy statement will be applied in specific contexts.  These steps could include guidance documents for specific products or substances, targeted workshops and postings of answers to frequently asked questions.  The Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials will be updated as comments are received, as the body of scientific evidence increases, and as international norms progress.

If you have any questions, contact [email protected].

Strangely, there’s no mention of the 29 submissions that were made (my May 27, 2011 posting)  or a listing of who made the submissions as was done for Canada’s ‘innovation consultation’ or, more formally, the Review of Federal Support to Research and Development (which started in Oct. 2010 and ended in Feb. 2011 and received some 250 submissions).

Nano regulatory frameworks are everywhere!

The scene around nanotechnology regulatory frameworks has been frantic (by comparison with any other time period during the 3 years I’ve been blogging about nano) in the last month or so. This is my second attempt this month at pulling together information about nanotechnology regulatory frameworks (my June 9, 2011 posting).

I’ll start off slow and easy with this roundup of sorts with a brief look at the international scene, move on to US initiatives, offer a brief comment on the Canadian situation, and wrap up with Europe.

International

Dr. Andrew Maynard at the University of Michigan Risk Science Center (UMRSC) blog has written a commentary about the ISO’s (*International Organization for Standardization) latest set of nanotechnology guidelines in his May 27, 2011 posting.  From the posting,

ISO/TR 31321:2011: Nanotechnologies – Nanomaterial risk evaluation is unashamedly based on the Environmental Defense Fund/DuPont Nano Risk Framework. Much of the structure and content reflects that of the original – a testament to the thought and effort that went into the first document. …The ISO report is written in a much tighter style than that of the original document, and loses some of the occasionally long-winded expositions on what should be done and why. And the ISO document is more compact – 66 pages as opposed to 104. But from a comparative reading, surprisingly little has been changed from the 2007 document.

It’s build around a framework of six steps:

  1. describe materials and applications
  2. material profiles
  3. evaluate risks
  4. assess risk management options
  5. decide, document, and act
  6. review and adapt

From the posting,

Inherent to this framework is the need to make situation-specific decisions that are guided by the Technical Report but not necessarily prescribed by it, and the need to constantly review and revise procedures and decisions. This built-in flexibility and adaptability makes ISO/TR 31321 a powerful tool for developing tailored nanomaterial management strategies that are responsive to new information as it becomes available. It also presents an integrative approach to using materials safely, that deals with the need to make decisions under considerable uncertainty by blurring the line between risk assessment and risk management.

Andrew’s view of these guidelines is largely positive and you can get more details and history by viewing his original commentary. (I first mentioned these new ISO guidelines in my May 18, 2011 posting.)

Sticking with the international scene (in this case, ISO), there was a June 13, 2011 news item on Nanowerk about a new ISO general liability classification for nanotechnology and alternative energy (from the news item),

The new classifications to address the growing use of nanotechnology are Nanomaterial Distributors and Nanomaterial Manufacturing. The once-limited use of nanotechnology in electronics and information technology industries is now swiftly permeating the consumer marketplace, from cosmetics to clothing and more. The Nanomaterial Distributors classification applies to risks that sell nanomaterials to others, and the Nanomaterial Manufacturing classification applies to risks that manufacture or engineer nanomaterials for others.

“With heightened interest to reduce the carbon footprint, establish energy independence, and increase the use of renewable resources, alternative power is a priority for many,” said Beth Fitzgerald, vice president of commercial lines and modeling at ISO. “In response to the growing demand for alternative energy, ISO introduced classifications for risks in three main areas: biofuels, solar energy, and wind energy. The new classifications will allow for future evaluation of the loss experience of those emerging markets.”

The biofuels classifications consist of Biofuels Manufacturing and Biofuels Distributors. Since ethanol already has a widespread and accepted use, a further distinction is made between “ethanol” and “biofuels other than ethanol.”

The solar energy classifications include Solar Energy Farms, Solar Energy Equipment Dealers or Distributors, and Solar Energy Equipment Manufacturing. The wind energy classifications include Wind Turbine Contractors – Installation, Service, or Repair and onshore and offshore Wind Farms.

* I have for many years understood that ISO is the International Standards Organization and I see from a note on the UMRSC blog that these days it is the International Organization for Standardization.

US

On the US front, three different agencies have made announcements that in one way or another will have an impact on the nanotechnology regulatory frameworks in that country.

The White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) recently released a set of principles for the regulation and oversight of nanotechnology applications and guidance for the development and implementation of policies at the agency level. From the June 9, 2011 news item on Nanowerk,

The realization of nanotechnology’s full potential will require continued research and flexible, science-based approaches to regulation that protect public health and the environment while promoting economic growth, innovation, competitiveness, exports, and job creation.

In furtherance of those goals, the White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) has developed a set of principles (pdf) specific to the regulation and oversight of applications of nanotechnology, to guide the development and implementation of policies at the agency level.

These principles reinforce a set of overarching principles (pdf) for the regulation and oversight of emerging technologies released on March 11, 2011. They also reflect recommendations from a report on nanotechnology (pdf) by the President’s Council of Advisors on Science and Technology. The report encourages Federal support for the commercialization of nanotech products and calls for the development of rational, science- and risk-based regulatory approaches that would be based on the full array of a material’s properties and their plausible risks and not simply on the basis of size alone.

You can read more about the guidelines at Nanowerk or on the Environemental Expert website here.

Back over on the UMRSC blog, Dr. Andrew Maynard had these comments in his June 13, 2011 posting,

In a joint memorandum, the Office of Science and Technology Policy, the Office of Management and Budget and the Office of the United States Trade Representative laid out Policy Principles for the U.S. Decision Making Concerning Regulations and Oversight of Applications of Nanotechnology and Nanomaterials.

Reading through it, a number of themes emerge, including:

  • Existing regulatory frameworks provide a firm foundation for the oversight of nanomaterials, but there is a need to respond to new scientific evidence on potential risks, and to consider administrative and legal modifications to the regulatory landscape should the need arise.
  • Regulatory action on nanomaterials should be based on scientific evidence of risk, and not on definitions of materials that do not necessarily reflect the evidence-based likelihood of a material causing harm.
  • There should be no prior judgement on whether nanomaterials are intrinsically benign or harmful, in the absence of supporting scientific evidence.
  • Transparency and communication are important to ensuring effective evidence-based regulation.

Overall, this is a strong set of policy principles that lays the groundwork for developing regulation that is grounded in science and not swayed by speculative whims, and yet is responsive and adaptive to emerging challenges. Gratifyingly, the memorandum begins to touch on some of the concerns I have expressed previously about approaches to nanomaterial regulation that seem not to be evidence-based. There is a reasonable chance that they will help move away from the dogma that engineered nanomaterials should be regulated separately because they are new, to a more nuanced and evidence-based approach to ensuring the safe use of increasingly sophisticated materials. Where it perhaps lacks is in recognizing the importance of other factors in addition to science in crafting effective regulation, and in handling uncertainty in decision making.

June 9, 2011 was quite the day as in addition to the White House documents, the US Environmental Protection Agency (EPA) and the US Food and Drug Administration (FDA) both announced public consultations on nanotechnology regulation.

From the June 9, 2011 news item on Nanowerk about the US EPA public consultation,

The U.S. Environmental Protection Agency announced today it plans to obtain information on nanoscale materials in pesticide products. Under the requirements of the law, EPA will gather information on what nanoscale materials are present in pesticide products to determine whether the registration of a pesticide may cause unreasonable adverse effects on the environment and human health. The proposed policy will be open for public comment.

“We want to obtain timely and accurate information on what nanoscale materials may be in pesticide products, “said Steve Owens assistant administrator for EPA’s Office of Chemical Safety and Pollution Prevention. “This information is needed for EPA to meet its requirement under the law to protect public health and the environment.”

Comments on the Federal Register notice will be accepted until 30 days after publication. The notice will be available at www.regulations.gov in docket number EPA–HQ–OPP–2010-0197. More information or to read the proposed notice: http://www.epa.gov/pesticides/regulating/nanotechnology.html [Pesticides; Policies Concerning Products Containing Nanoscale Materials; Opportunity for Public Comment]

The US FDA has taken a more complicated approach to its public consultation with two notices being issued about the same consultation. The June 9, 2011 news item on Nanowerk had this to say,

The U.S. Food and Drug Administration today released draft guidance to provide regulated industries with greater certainty about the use of nanotechnology, which generally involves materials made up of particles that are at least one billionth of a meter in size. The guidance outlines the agency’s view on whether regulated products contain nanomaterials or involve the application of nanotechnology.

The draft guidance, “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology”, is available online and open for public comment. It represents the first step toward providing regulatory clarity on the FDA’s approach to nanotechnology.

Specifically, the agency named certain characteristics – such as the size of nanomaterials used and the exhibited properties of those materials – that may be considered when attempting to identify applications of nanotechnology in regulated products.

“With this guidance, we are not announcing a regulatory definition of nanotechnology,” said Margaret A. Hamburg, MD, Commissioner of Food and Drugs. “However, as a first step, we want to narrow the discussion to these points and work with industry to determine if this focus is an appropriate starting place.”

Then there was a June 15, 2011 news item on Nanowerk offering more details about the draft guidance announcement of June 9, 2011,

The guidelines list things that might be considered when deciding if nanotechnology was used on a product regulated by FDA—including the size of the nanomaterials that were used, and what their properties are.

And FDA wants industry leaders and the public to weigh-in.

Nanotechnology—the science of manipulating materials on a scale so small that it can’t be seen with a regular microscope—could have a broad range of applications, such as increasing the effectiveness of a particular drug or improving the packaging of food or cosmetics. “Nanotechnology is an emerging technology that has the potential to be used in a broad array of FDA-regulated medical products, foods, and cosmetics,” says Carlos Peña, director of FDA’s emerging technology programs. “But because materials in the nanoscale dimension may have different chemical, physical, or biological properties from their larger counterparts, FDA is monitoring the technology to assure such use is beneficial.”

In other words, using nanotechnology can change the way a product looks or operates, Peña says.

Although the technology is still evolving, it’s already in use as display technology for laptop computers, cell phones, and digital cameras. In the medical community, a number of manufacturers have used nanotechnology in:

  • Drugs
  • Medical imaging
  • Antimicrobial materials
  • Medical devices
  • Sunscreens

Andrew Maynard in his previously noted June 13, 2011 posting on on the UMRSC blog had this to say  about the EPA’s draft document,

This is a long and somewhat convoluted document, that spends some time outlining what the agency considers is an engineered nanomaterial, and reviewing nanomaterial hazard data.

Reading the document, EPA still seems somewhat tangled up with definitions of engineered nanomaterials. After outlining conventional attributes associated with engineered nanomaterials, including structures between ~1 – 100 nm and unique or novel properties, the document states,

“These elements do not readily work in a regulatory context because of the high degree of subjectivity involved with interpreting such phrases as “unique or novel properties” or “manufactured or engineered to take advantage of these properties” Moreover the contribution of these subjective elements to risk has not been established.”

This aligns with where my own thinking has been moving in recent years. Yet following this statement, the document reverts back to considering nanoparticles between 1 – 100 nm as the archetypal nanomaterial, and intimates “novel” properties such as “larger surface area per unit volume and/or quantum effects” as raising new risk concerns.

Canadian segue

I’ll point out here that Health Canada’s Interim Policy definition also adheres to the 1 to 100 nm definition for a nanomaterial, a concern I expressed in my submission to the public consultation held last year. Interestingly, since 29 submissions does seem particularly daunting to read there has yet to be any public response to these submissions. Not even a list of which agencies and individuals made submissions.

Back to US

Andrew also comments on the FDA document,

The FDA Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology is a very different kettle of fish to the EPA document. It is overtly responsive to the White House memo; it demonstrates a deep understanding of the issues surrounding nanotechnology and regulation; and it is mercifully concise.

To be fair, the scope of the draft guidance is limited to helping manufacturers understand how the agency is approaching nanotechnology-enabled products under their purview. But this is something it does well.

One of the more significant aspects of the guidance is the discussion on regulatory definitions of nanomaterials. Following a line of reasoning established some years ago, the agency focuses on material properties rather than rigid definitions:

“FDA has not to date established regulatory definitions of “nanotechnology,” “nanoscale” or related terms… Based on FDA’s current scientific and technical understanding of nanomaterials and their characteristics, FDA believes that evaluations of safety, effectiveness or public health impact of such products should consider the unique properties and behaviors that nanomaterials may exhibit”

I recommend reading the full text of Andrew’s comments.

Europe

Meanwhile, there was a June 10, 2011 news item on Nanowerk about the availability of  28 presentations from a May 10-12, 2011 joint European workshop hosted by the Engineered NanoParticle Risk Assessment (ENPRA) FP (Framework Programme) 7 project and the European Commission’s Joint Research Centre. From the news item about the Challenges of Regulation and Risk Assessment of Nanomaterials workshop,

Twenty-eight presentations delivered at the Joint JRC Nano event and 2nd ENPRA Stakeholders Workshop are now available on-line: ENPRA Workshop 2011 – Programme with Presentations.

The workshop (by invitation only) involved about 90 participants, from industry, government, NGOs, and academia. …

During two days and a half, 34 experts from 26 different organisations informed the participants on the latest scientific progress in the field of nanoparticles risk assessment produced within national and European projects, and first results of ENPRA FP7 project were presented in detail. In addition, recent developments concerning legislation in the EU and beyond were discussed.

Amongst other participants, you can include representatives of EU Associate and Candidate Countries, environment and workers’ protection organisations, CAIQ (Chinese Academy of Inspection and Quarantine), US-EPA, ECHA, and EFSA.

To close this piece (and I want to do that very badly), I’m going to give Tim Harper at his TNT blog (on the Cientifica website) the final word from his June 10, 2011 posting,

The White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) has developed a set of principles (pdf) specific to the regulation and oversight of applications of nanotechnology, to guide the development and implementation of policies at the agency level.

I’m glad to see that it addresses those two old bugbears, the confusion between risk and hazard and the prejudging of issues without reference to scientific evidence …

It is an approach which appears to diverge slightly from the European adoption of the precautionary principle …

As with any regulation, the problems will arise not from the the original wording, but through its (mis)interpretation and inconsistent application.

Update on Canada’s Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials public consultation

As usual I found the information about last year’s public consultation on the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials in an OECD (Organization for Economic Cooperation and Development) report. The report which includes an accounting from several member countries including Canada about a range of activities relating to nanomaterial safety is titled, OECD Environment, Health and Safety Publications Series on the Safety of Manufactured Nanomaterials, No. 29: Current Developments/Activities on the Safety of Manufactured Nanomaterials Tour De Table at The 8th Meeting of the Working Party On Manufactured Nanomaterials, Paris, France 16-18 March 2011.

Here’s what the report had to say about the public consultation on the interim policy statement,

The six month web-based public consultation for the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials ended on August 31, 2010. A total of 29 submissions were received from a range of stakeholders. The majority of comments were received from industry; however, public interest groups, government bodies, and private individuals also submitted comments. The comments focussed on the process of the development of the working definition, the content or meaning of particular terms, and its application or use. Health Canada is currently reviewing and considering all comments received as well as key developments of other definitions of nanomaterials, including those of the International Organisation for Standardisation and the European Commission. (p. 24)

I last posted an update about this public consultation in my Jan. 20, 2011 posting. From my posting,

A reader sent in a response to a query about the public consultation’s status since it closed Aug. 31, 2011.

Consultation Results – Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials

Dear [XXX],

Thank you for your interest in the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials (Interim Policy Statement). Extensive comments were received from a wide-range of stakeholders.

Health Canada is currently reviewing and considering all comments, and any necessary revisions to the Interim Policy Statement. Further information on how Health Canada will address these comments, including any possible amendments to the policy statement will be made available on Health Canada’s Web site soon. Stakeholders will be notified at that time. [emphasis mine]

Thank you

Science Policy Directorate/La direction des politiques scientifiques
Strategic Policy Branch/Direction générale de la politique stratégique
Health Canada/Santé Canada

I guess they were still counting the responses in January so they could be ready for the March report in Paris. As for updates on the Health Canada site, the Health Canada webpage hosting the interim policy has not been updated since Feb. 11, 2010 according to the Date Modified notice at the bottom of the page.

Here’s an excerpt from the report about at least some of the nanomaterial scientific research and policy work taking place in Canada,

Scientific research

Health Canada is starting a research project to investigate the toxicity of surface-modified silica
nanoparticles entitled “Evaluation of Toxic Potency of Silica-based Nanoparticles using High-throughput Integrated In Vitro Cytotoxicity Assay Platform”. The aim of the project is to investigate the importance of size and surface modification on the toxicity of silica nanoparticles. The silica nanoparticles used in the project will be synthesised and modified according to specific parameters to better reflect those that are of greatest interest to the New Substances Program. This project is designed as a proof of concept and will be extended over the fiscal years 2010-2011 and 2011-2012.

Canada has supported multiple research projects under the Strategic Grants Program of the Natural Sciences and Engineering Research Council (NSERC). The nanomaterials used in these projects have included OECD priority nanomaterials such as TiO2. The projects examined fate both in the aqueous and the subsurface compartments and include establishing methodologies for suspension and physical-chemical characterisation of the nanomaterials prior to any exposure testing.

A larger Canadian initiative is a multidisciplinary, 3-year collaborative project that brings together: 1) industry and academic/government researchers involved in the engineering and production of new and existing commercial nanomaterials, 2) representatives involved in the current regulatory testing industry that require new, cost-effective, time-sensitive, and efficient testing methods, 3) academic/government researchers who can develop and apply new technologies to the area of safe nanomaterials production and effective ecotoxicology testing, and 4) Canadian regulatory community. The goal of the project is to understand the fate and effects of nanomaterials (including OECD priority materials) in the aquatic environment, with specific themes targeting (1) synthesis; (2) characterisation in complex media; (3)
methods for biological effects testing; and (4) establishing collaborative dialogue between key stakeholders.

Funding and partnering opportunities are currently being considered by Canada to a) develop in-house analytical chemistry infrastructure for the measurement of nanoparticles in food; b) to assess the health effects of orally ingested nanomaterials for addressing exposure through food contamination from packaging materials, or through nanostructures in food additives; c) to evaluate the effects of nanomaterials in food on nutrient bioavailability, functionality and efficacy for addressing the regulation of nanotech products designed.

Canada is also currently engaged in both in-house and collaborative research projects involving a range of different nanomaterials (e.g., nanoparticulates of zero-valent iron, gold, silver, TiO2, single walled carbon nanotubes, and C60 fullerenes). Testing includes pulmonary and cardiovascular injury; reproductive, developmental and transgenerational effects; exposure and tissue penetration, interactive effects with microorganisms, immune defences, and genotoxicity. Alternative tests such as molecular (genomic/ proteomic) and cellular in vitro techniques play an important part of the repertoire for such investigations. Other on-going projects include developing bioassays and biomarkers for nanomaterials, harmonising and
standardising chemical and toxicological assays, toxicogenomics, evaluating fate in aquatic environments understanding the interaction of nanoparticles with microbial cells, soil effects research, and bioaccumulation and toxicity in benthic invertebrates.

Canada (Environment and Health Canada), together with Government agencies in the United States, Non- Governmental Organisations and Industry are supporting a project lead out of the International Life Sciences Institute (ILSI) to look at releases of nanomaterials from industrial matrices (e.g., coatings). The purpose of the project is (a) to compile literature information on different test methodologies and nanomaterials used to study releases from matrices (e.g., coatings); and (b) develop standard methodologies (validated through round-robin testing) to quantify releases of nanomaterials from a matrix.

At the current stage, the Steering Committee for the project is selecting primary materials in advance of an expert workshop being planned in Fall 2011. The expert workshop will inform on path forward on a testing regime for the materials and matrices selected. Additional information can be found at

http://www.ilsi.org/ResearchFoundation/Pages/NanoRelease1.aspx

Policy research

Canada participates in the project on Regulatory Framework for Nanotechnology in Food and Medical Products, The project is composed of two independent surveys addressing the same set of questions related to: (1) the regulatory frameworks being used to provide oversight for the use of nanotechnology in food and medical products, (2) the legislative frameworks relevant to these regulatory frameworks, and (3) relevant government-supported research programmes and institutions. The surveys have been circulated to member countries to be filled by March 2011.

The information generated by the surveys will be used to populate inventories, and draft a report on areas of shared interest and highlight opportunities for enhancing communication related to regulation and applications of nanotechnology in food and medical products. The report is expected to be completed in 2011/2012. (pp. 25-6)

Some of this looks familiar to me (these reports tend to regurgitate the same information for years) but there does seem to be more detail than usual in this report.

Update on Health Canada’s public consultation on its Interim Policy Statement on a Working Definition for Nanomaterials

A reader sent in a response to a query about the public consultation’s status since it closed Aug. 31, 2011.

Consultation Results – Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials

Dear [XXX],

Thank you for your interest in the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials (Interim Policy Statement). Extensive comments were received from a wide-range of stakeholders.

Health Canada is currently reviewing and considering all comments, and any necessary revisions to the Interim Policy Statement. Further information on how Health Canada will address these comments, including any possible amendments to the policy statement will be made available on Health Canada’s Web site soon. Stakeholders will be notified at that time. [emphasis mine]

Thank you

Science Policy Directorate/La direction des politiques scientifiques
Strategic Policy Branch/Direction générale de la politique stratégique
Health Canada/Santé Canada

Thank you to my reader. I wonder how they define a stakeholder?

After receiving the message, I checked out the Health Canada website page again and found this under Reporting to Canadians,

Health Canada will make the results of this consultation available on this Web site. Health Canada will take further steps to illustrate how the policy statement will be applied in specific contexts. These steps could include guidance documents for specific products or substances, targeted workshops and postings of answers to frequently asked questions. The Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials will be updated as comments are received, as the body of scientific evidence increases, and as international norms progress.

In my April 26, 2010 posting, I published an interview with a Health Canada representative (Christelle Legault) about Canada’s nanomaterials definition, a nanomaterials inventory that was announced in January 2009 (but not yet implemented), and a proposed nanoportal for Spring 2010 (still not launched). I’m hopeful they will find it easier to publish the results of the consultation than they have found the implementation of their other initiatives. Perhaps the inventory and the nanoportal are contingent on a nanomaterials definition?

European Consumer Groups’ response to public consultation on nanomaterial definition

The ANEC (The European Consumer Voice in Standardisation) and the BEUC (European Consumers’ Organisation) have issued a joint response to the European Commission’s public consultation, which was open from Oct. 21, 2010 to Nov. 19, 2010 (and mentioned in my Oct. 25, 2010 posting).

From the Nov. 23, 2010 news item on Nanowerk,

1. The proposed size range of up to 100nm is too limited

The Commission draft recommendation foresees basing the term “nanomaterial” on the size range of 1nm to 100nm. Those are also the limits contained in the ISO 27687 standard published in 2008. However, most recent scientific knowledge seems to point out that this size limit seems to be too restrictive and risks that certain nanomaterials will not be properly risk assessed with regard to their potential toxicity.

Recent studies finding that carbon nanotubes can cause the same disease as asbestos fibres received world wide attention (Poland et al. 2008; Takagi et al. 2008). Yet many of the nanotubes in the studies measured >100nm and so would not be considered to be ‘nanomaterials’ using a <100nm size-based definition. Poland et al. (2008) found that two samples of long, tangled multi-walled carbon nanotubes caused asbestos-like pathogenicity when introduced into the stomachs of mice. One of their two samples had a diameter of 165nm and a length of greater than 10µm. Similarly, Takagi et al. (2008) found that in a long term study, more mice died from mesothelioma following exposure to multi-walled carbon nanotubes than died following exposure to crocidolite (blue) asbestos. In this study >40% of sample nanotubes had a diameter >110nm.

Today, we still do not know enough about the new properties of materials at the nanoscale. For this reason, it will be crucial to apply a broad definition to nanomaterials. This is also confirmed by the SCENIHR’s opinion that “there is no scientific evidence to qualify the appropriateness of the 100 nm value”.

The approach to go beyond 100nm has already been followed by some public authorities such as the Federal Office for Public Health and the Federal Office for the Environment in Switzerland which recommend 500nm to be used as the limit of the nanoscale in order to avoid excluding any nano-specific risk.

Concrete examples where a limitation to 100nm may cause problems

– At a workshop on nanotechnologies which had been organised by DG SANCO on 22 October, it has been discussed that in the case of pharmaceuticals the size range of 100nm may be inadequate. As nanomedicines may be at the range of about 1000nm, a definition which is not appropriate for nanomedicines may hamper research and risk assessment. Thus, an EU definition needs to take into account the specific needs of nanomedicines.

– The current REACH legislation shows severe shortcomings when it comes to nanomaterials. We see an urgent need to consider all nanomaterials as new substances under REACH. Moreover, the volume threshold for registration of 1 ton per annum seems to be inadequate for nanomaterials and should be lowered to e.g. 10kg. Limiting the definition of nanomaterials to 100nm could create a new loophole in the future as substances which are slightly bigger than 100nm may escape from the above mentioned requirements that should apply to all nanomaterials.

2. Definition should include agglomerates and aggregates

A definition for regulatory purposes should include agglomerates and aggregates as they often show physiochemicals properties which may pose safety concerns. For this reason we welcome that the Draft Recommendation includes nanoparticles that have a specific surface area by volume greater than 60 m2/cm3.

You can get the entire recommendation (5 pp.) including references from here.

This puts me in mind of Health Canada’s public consultation on a nanomaterials definition. I did put in a submission to the consultation which closed in August and have yet to hear of any results from this process. I did find this notice on their Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials page,

This consultation is now closed. Comments and suggestions received during this consultation period are being considered in any necessary revisions to the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials. Health Canada will make available information to further clarify the use of this policy statement.

Couldn’t they tell us how many responses they got and maybe share a little information?

Latest report on Canada’s work on nanomaterial safety via an OECD report

As usual I’m getting the best and most comprehensive overview of Canada’s current safety efforts with regard to nanomaterials from an external source, an OECD (Organization for Economic Cooperation and Development) report. From the news item on Nanowerk,

A new document from the OECD (“Current Developments/Activities on the Safety of Manufactured Nanomaterials”; pdf) provides information on current/planned activities related to the safety of manufactured nanomaterials in OECD member and non-member countries that attended at the 7th meeting of OECD’s Working Party on Manufactured Nanomaterials (Paris France, 7-9 July 2010).

This new document compiles information provided by member countries and other delegations on current developments on the safety of manufactured nanomaterials (section I) in their countries or organisations. …

This is intended to provide delegations and other stakeholders with a “snapshot” of information on activities related to manufactured nanomaterials, as well as other activities on nanotechnologies, at the national and international level. This “snapshot” was current at the time of the 7th meeting of the WPMN (July 2010).

For anyone who is interested, the report can be found here. I did take a look at the section on Canada. From the report,

A. Canada has announced the adoption of the Interim Policy Statement on Canada’s Working Definition for Nanomaterials and it’s public posting (http://www.hc-sc.gc.ca/srsr/ consult/_2010/nanomater/draft-ebauche-eng.php).The Interim Policy is now in effect and comments on this policy statement are being accepted until August 31st, 2010. [now closed]

Currently, the Acts and Regulations administered by Canada have no explicit reference to nanomaterial. Among four key objectives, this policy statement establishes a transparent working means of identifying nanomaterials. It will also provide Canada with a consistent set of approaches and a trigger to request information. Given the range of nanomaterial-related regulatory responsibilities in Canada, the working definition is intentionally broad and will be applied more specifically in each regulatory programme area.

In preparing the Interim Policy Statement on Canada’s Working Definition for Nanomaterials, Canada sought the informal feedback of some international stakeholders, industry trade groups and standards associations.

B. A Workshop on the Human and Environmental Risk Assessment of Nanomaterials was convened by Canada from March 24-26, 2010. This workshop provided an open forum for detailed dialogue on nanomaterials among science evaluators, research scientists and regulators. The Workshop was attended by experts from Australia, Canada, Europe, Korea and the United States of America.

The Workshop was designed to be complementary to the work of the OECD Working Party on Manufactured Nanomaterials (WPMN) and followed on from the recent Workshop on Risk Assessment in a Regulatory Context that took place September 16-18, 2009 in Washington DC. Workshop participants agreed that scientific knowledge on the properties, environmental fate, behaviour and toxicity of nanomaterials is advancing, however, currently is still inadequate to allow general trends/structure-activity relationships to be made. Nanomaterials should continue to be assessed on a case-by-case basis, efforts should be made to minimize exposures and releases to the extent possible, and jurisdictions should continue to cooperate on research projects aimed at the development of scientific data on nanomaterials. Workshop participants emphasised that exchanges of information and views on nanomaterials at this time are especially helpful for promoting best practices in risk assessment and risk management.

C. Canadian Standards Association (CSA) Standards has formed a Technical Committee on Nanotechnologies – Occupational Health and Safety. Initial activities include working to adopt the published international ISO Technical Report, ISO/TR 12885:2008 on Health & Safety Practices in Occupational Settings relevant to Nanotechnologies, as well as to produce a national standard to provide guidance for workers using nanomaterials in the workplace. The Committee’s inaugural meeting was held on May 7th, 2009 and work is continuing in subsequent meetings through 2010.

D. Canada is the lead for the ISO TC/229 WG1 Task Group on Nomenclature. This Task Group includes active representation from the United States, Japan, Germany, France, Australia, and includes regulators, industry, and academia, as well as observers from the Chemical Abstracts Service and the International Union of Pure and Applied Chemistry (IUPAC).The Group is tasked with developing a nomenclature system which meets the needs of regulators, industry, and academia. In July 2009 the Task Group completed the report: “Considerations for Developing a Nomenclature Model for Nano-Objects”. Canada has now welcomed United States in co-chairing this activity, and is continuing development of a framework for nomenclature models for nano-objects. Canada has pursued and secured a liaison between ISO/TC 229 and IUPAC to further this nomenclature work.

E. Canada has completed a report titled, Nanotechnologies — Terminology – Initial framework model for core concepts, under ISO TC/229 JWG1. Also, Canada has led a project (JWG1-PG5) to develop definitions for core terms resulting from the taxonomy system. ISO 80004-1 Nanotechnologies — Vocabulary — Part 1: Core terms has now been approved after ISO Draft Technical Specification balloting.

F. Under the International Cooperation on Cosmetic Regulation (ICCR), Canada is participating in the international ad hoc working group on nanomaterials in cosmetics (ICCR Nano WG) that was initiated in December 2009. This working group is composed of regulators and industry representatives to identify specific criteria for nanomaterials in cosmetics. Completion of recommended criteria for ICCR acceptance is expected in July 2010. The ICCR Nano WG will then commence work on endpoints for risk assessment relevant to cosmetics safety (starting late 2010). (pp.22/3)

I have mixed feelings about this, appreciation that we’re doing work on nanomaterials and safety and frustration that the best source of information is in a report produced by an international organization.

There’s more information about various Canadian nanosafety projects  in the report including a reference to Québec’s recent IRSST (Institut de recherche Robert-Sauvé en santé et en sécurité du travail) on safety and engineered nanoparticles. Here’s a bit more,

Canada has supported multiple research projects under the Strategic Grants Program of the Natural Sciences and Engineering Research Council (NSERC). The nanomaterials used in these projects have included OECD priority nanomaterials such as TiO2. The projects examined fate both in the aqueous and the subsurface compartments and include establishing methodologies for suspension and phys-chem characterisation of the nanomaterials prior to any exposure testing.

A larger Canadian initiative is a multidisciplinary, 3-year collaborative project that brings together: 1) industry and academic/government researchers involved in the engineering and production of new and existing commercial nanomaterials, 2) representatives involved in the current regulatory testing industry that require new, cost-effective, time-sensitive, and efficient testing methods, 3) academic/government researchers who can develop and apply new technologies to the area of safe nanomaterials production and effective ecotoxicology testing, and 4) Canadian regulatory community. The goal of the project is to understand the fate and effects of nanomaterials (including OECD priority materials) in the aquatic environment, with specific themes targeting (1) synthesis; (2) characterisation in complex media; (3) methods for biological effects testing; and (4) establishing collaborative dialogue between key stakeholders. Funding and partnering opportunities are currently being considered by Canada to a) develop in-house analytical chemistry infrastructure for the measurement of nanoparticles in food; b) to assess the health effects of orally ingested nanomaterials for addressing exposure through food contamination from packaging materials, or through nanostructures in food additives; c) to evaluate the effects of nanomaterials in food on nutrient bioavailability, functionality and efficacy for addressing the regulation of nanotech products designed. Canada is also currently engaged in both in-house and collaborative research projects involving a range of different nanomaterials (e.g., nanoparticulates of zero-valent iron, gold, silver, TiO2, also carbon black, single walled carbon nanotubes, and C60 fullerenes). Testing includes pulmonary and cardiovascular injury; reproductive, developmental and transgenerational effects; exposure and tissue penetration, interactive effects with microorganisms, immune defenses, and genotoxicity. Alternative tests such as molecular (genomic/proteomic) and cellular in vitro techniques play an important part of the repertoire for such investigations. Other on-going projects include developing bioassays and biomarkers for nanomaterials, harmonizing and standardizing chemical and toxicological assays, toxicogenomics, evaluating fate in aquatic environments understanding the interaction of nanoparticles with microbial cells, soil effects research, and bioaccumulation and toxicity in benthic invertebrates. Canada has hosted various workshops pertaining to challenges in nanotechnology, such as the 4th Tri- National Workshop on Standards for Nanotechnology (Feb, 2010), which addressed measurement and characterisation in support of toxicology R&D for Human Health and Environment., focusing on identification of measurands for toxicological research on nano-objects, and the measurement science supporting accurate measurement and characterisation. This workshop supported the Canadian contribution to the North American Platform Program (NAPP) in Metrology in Support of Nanotechnology, strengthening partnerships between Canada, the United States and Mexico. Information on the 4th Tri- National Workshop on Standards for Nanotechnology is available at: https://www.nrccnrc. gc.ca/eng/events/inms/2010/02/03/tri-national workshop.html. (p. 25)

I’d never heard of the Tri-National Workshop on Standards before or the work on measuring and assessing the safety of nanoparticles in foods or some of the other initiatives for that matter. I’ve noted before that it seems odd that laudable work such as this is being kept, to all intents and purposes, secret.

There’s a section for public consultation which boasts the one (closed as of Aug. 31, 2010) for the Interim Policy Statement on Canada’s Working Definition for Nanomaterials. I commented on this consultation, which was hosted by Health Canada, in my April 2, 2010, April 12, 2010, and April 26, 2010 postings. I also made a submission and wonder if I’ll ever hear back from anyone about it. I don’t imagine so.

I notice that this OECD report does not include any reference to Canada’s nano portal (as I recall, the last OECD report did mention it). The nanoportal has been opened (I’m not sure when).

Comparing nanomaterials definitions: US and Canada

In light of yesterday’s (April 26, 2010) posting about Health Canada and their nanomaterials definition, Andrew Maynard’s April 23, 2010 post at 2020 Science (blog) is quite timely. Andrew has some details about new nanomaterials definitions being proposed in the both the US Senate and House of Representatives so that their Toxic Substances Control Act can be amended. From Andrew’s posting, an excerpt about the proposed House bill,

The House draft document is a little more explicit. It recommends amending section 3(2) of the original act with:

“(C) For purposes of this Act, such term may include more than 1 form of a substance with a particular molecular identity as described in sub-paragraph (A) if the Administrator has determined such forms to be different substances, based on variations in the substance characteristics. New forms of existing chemical substances so determined shall be considered new chemical substances.” (page 6)

with the clarification that

“The term ‘substance characteristic’ means, with respect to a particular chemical substance, the physical and chemical characteristics that may vary for such substance, and whose variation may bear on the toxicological properties of the chemical substance, including—

(A) chemical structure and composition

(B) size or size distribution

(C) shape

(D) surface structure

(E) reactivity; and

(F) other characteristics and properties that may bear on toxicological properties” (page 11)

Both the Senate bill and the House discussion document provide EPA with the authority to regulate any substance that presents a new or previously unrecognized risk to human health as a new substance. This is critical to ensuring the safety of engineered nanomaterials, where risk may depend on more than just the chemistry of the substance. But it also creates a framework for regulating any new material that presents a potential risk – whether it is a new chemical, a relatively simple nanomaterial, a more complex nanomaterial – possibly one that changes behavior in response to its environment, or a novel material that has yet to be invented. In other words, these provisions effectively future-proof the new regulation.

I prefer the definition in the draft House of Representatives bill to Health Canada’s because of its specificity and its future-oriented approach. Contrast their specificity with this from the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials:

Health Canada considers any manufactured product, material, substance, ingredient, device, system or structure to be nanomaterial if:

1. It is at or within the nanoscale in at least one spatial dimension, or;

2. It is smaller or larger than the nanoscale in all spatial dimensions and exhibits one or more nanoscale phenomena.

For the purposes of this definition:

* The term “nanoscale” means 1 to 100 nanometres, inclusive;

* The term “nanoscale phenomena” means properties of the product, material, substance, ingredient, device, system or structure which are attributable to its size [emphasis mine] and distinguishable from the chemical or physical properties of individual atoms, individual molecules and bulk material; and,

* The term “manufactured” includes engineering processes and control of matter and processes at the nanoscale.

You’ll notice the House of Representatives’ draft bill offers five elements to the description (chemical composition, size or size distribution [emphasis mine], shape, surface structure, reactivity, and other characteristics and properties that may bear on toxicological properties). So in the US they include elements that have been identified as possibly being a problem and leave the door open for future discovery.

The proposed legislation has another feature, Andrew notes that,

Both the Senate bill and the House discussion document provide EPA with the authority [emphasis mine] to regulate any substance that presents a new or previously unrecognized risk to human health as a new substance. This is critical to ensuring the safety of engineered nanomaterials, where risk may depend on more than just the chemistry of the substance. But it also creates a framework for regulating any new material that presents a potential risk – whether it is a new chemical, a relatively simple nanomaterial, a more complex nanomaterial – possibly one that changes behavior in response to its environment, or a novel material that has yet to be invented. In other words, these provisions effectively future-proof the new regulation.

As far as I can recall, Peter Julian’s (MP – NDP) tabled draft bill for nanotechnology regulation in Canada does not offer this kind of ‘future-proofing’ although it could be added if it is ever brought forward for debate in the House of Commons. Given the quantity of public and political discussion on nanotechnology (and science, in general) in Canada, I doubt any politician could offer those kinds of amendments to Julian’s proposed bill.

As for Canada’s proposed nanomaterials reporting plan/inventory/scheme, Health Canada’s proposed definition’s vagueness makes compliance difficult. Let me illustrate what I mean while I explain why I highlighted ‘size distribution’ in the House of Representatives draft bill by first discussing Michael Berger’s article on Nanowerk about environment, health and safety (EHS) research into the toxicological properties of nanomaterials. From Berger’s article,

” What we found in our work is that nanomaterials purchased from commercial sources may not be as well characterized as indicated by the manufacturer,” Vicki H. Grassian, a professor in the Department of Chemistry at the University of Iowa, tells Nanowerk. “For example, it might be stated that a certain nanoparticle is being sold as 30 nm in diameter and, although ’30 nm’ might be close to the average diameter, there is usually a range of particle sizes that can extend from as much as small as 5 nm to as large as 300 nm. [emphases mine]“

That’s size distribution and it reveals two problems with a reporting plan/inventory/scheme that uses a definition that sets the size within a set range. (Julian’s bill has the same problem although his range is 1 to 1000 nm.) First, what happens if you have something that’s 1001 nm? This inflexible and unswerving focus on size will frustrate the intent both of the reporting plan and of Julian’s proposed legislation. Second, how can a business supply the information being requested when manufacturers offer such a wide distribution of sizes in  products where a uniform size is claimed? Are businesses going to be asked to measure the nanomaterials? Two or three years or more after they received the products? [Aug.4.10 Note: Some grammatical changes made to this paragraph so it conveys my message more clearly.]

Then Berger’s article moves onto another issue,

Reporting their findings in a recent paper in Environmental Toxicology and Chemistry (“Commercially manufactured engineered nanomaterials for environmental and health studies: Important insights provided by independent characterization”), among other problems Grassian and first author Heaweon Park also discuss the issue of batch-to-batch variability during the production of nanoparticles and that some nanomaterials which were being sold as having spherical morphology could contain mixed morphologies such as spheres and rods [emphases mine].

That’s right, you may not be getting the same shape of nanoparticle in your batch. This variability should not pose a problem for the proposed reporting plan/inventory/scheme since shape is not mentioned in Health Canada’s definition but it could bear on toxicology issues which is why a plan/inventory/scheme is being proposed in the first place.

Interestingly, the only ‘public consultation’ meeting that Health Canada/Environment Canada has held appears to have taken place in 2007 with none since and none planned for the future (see my April 26, 2010 posting).

Apparently, 3000 stakeholders have been contacted and asked for responses. I do wonder if an organization like Nano Quebec has been contacted and counted not as a single stakeholder but as representing its membership numbers (e.g. 500 members = 500 stakeholders?) whatever they may be. There is, of course, a specific Health Canada website for this interim definition where anyone can offer comments. It takes time to write a submission and I’m not sure how much time anyone has to devote to it which is why meetings can be very effective for information gathering especially in a field like nanotechnology where the thinking changes so quickly. 2007 seems like a long time ago.

Finally, Dexter Johnson on his Nanoclast blog is offering more perspective on the recent Andrew Schneider/National Nanotechnology Initiative dust up. Yes, he gave me a shout out (and I’m chuffed) and he puts the issues together to provide a different perspective on journalistic reporting environment, health and safety issues as they relate to nanotechnology along with some of the issues associated with toxicology research.

Health Canada answers questions about a nanomaterials reporting plan/inventory and about its interim policy definition of nanomaterials; news flash: IBM & a plot to bomb their nanotech facility in Switzerland

I’ve been tracking down information about Canada’s manomaterials reporting plan/inventory/scheme since January 2009 when it was first announced publicly, i.e. somewhere other than a government report or government website. Here’s my most recent posting where I detail information found in a Feb. 2010 OECD (Organization for Economic Cooperation and Development) report. In my searches I also found a notice of a a request for comments (closing date: Aug. 31, 2010) about an Interim Policy Statement for Health Canada’s Working Definition for Nanomaterials . I gather this request for feedback/public consultation is being held prior to developing the ‘nanomaterials reporting plan’ for Canadian businesses to provide information about the nanomaterials in their products circa 2008.

The whole endeavour has been a bit puzzling so I emailed Health Canada with some questions which Christelle Legault, Media Relations Officer | Agente des relations avec les médias, Regulatory Communications and Media Relations Division | Division des communications réglementaires et des relations avec les médias, Public Affairs, Consultation and Communications Branch | Direction générale des affaires publiques, de la consultation et des communication, Health Canada | Santé Canada, very kindly answered. (Her business card must be very crowded.)

Q1 – Is information about this reporting plan/inventory/scheme publicly available other than in OECD documents? Where would the average Canadian be able to locate this info?

Plans to develop an information gathering initiative for nanomaterials were discussed as part of a previous multi-stakeholder workshop. Background information on this initiative is provided in the document entitled “Proposed Regulatory Framework for Nanomaterials under the Canadian Environmental Protection Act, 1999” available under “Nanomaterials” on Environment Canada’s New Substances Website at:

http://www.ec.gc.ca/subsnouvelles-newsubs

The New Substances Website is used to communicate information to stakeholders on the regulatory program for nanomaterials under the Canadian Environment Protection Act, 1999 (CEPA 1999).

Q2 – When is the projected date for the proposed reporting plan/inventory/scheme to take place? Will it be 2011?

Information gathering initiatives for nanomaterials are currently under consideration by the Government. At this time, there are no confirmed timelines.

Q3 – How did you promote this ‘Interim statement’ consultation so there’d be some response?

The Policy Statement on Health Canada’s Working Definition for Nanomaterials was distributed to over 3,000 stakeholders in Canada and internationally via e-mail, as well as being posted on Health Canada’s website:

http://www.hc-sc.gc.ca/sr-sr/consult/_2010/nanomater/index-eng.php

Q4 – Were you aware that your adopted definition for nanomaterials is not harmonious with the 2007 definition being used by Environment Canada where nano titanium dioxide (a very commonly used nanoparticle in many products) is explicitly excluded.

The New Substances Advisory Note that was published in 2007, entitled: Requirements for Nanomaterials under the New Substances Notification Regulations (Chemicals and Polymers), relates to existing legislation for nanomaterials under CEPA 1999. The Advisory Note does not define nanomaterials, rather it describes the requirements of existing legislation to notify new nanomaterials to the Government for assessment prior to import or manufacture.

Whereas, the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials is intended to provide guidance to stakeholders on the broad scope of what is considered a nanomaterial. The working definition establishes a working means of identifying nanomaterials that will support the administration of the various laws and regulations (including CEPA 1999) that the Government uses to regulate nanomaterials. The scope of the working definition is intended to be broad so that all Government legislative and regulatory programs are captured. In some cases, the scope of nanomaterials for specific regulatory programs may be narrower than that of Health Canada’s Working Definition.

Q5 – Are there plans for public outreach/dialogue/engagement events on the topic of nanomaterials and other nanotechnology issues?

HC will be providing feedback to stakeholders after the Interim Policy Statement consultation period is completed. Depending on the result of the consultation, HC will decide on the need to further engage the stakeholders.

Q6 – Is there going to be another multi-stakeholder meeting as there was in 2007, as per the OECD report?

There are currently no scheduled multi-stakeholder meeting concerning the Environment Canada-Health Canada nanomaterial regulatory program. However, the Government is committed to holding meaningful consultations with interested stakeholders as it further develops its nanomaterial regulatory program.

Q7 – If there will be another multi-stakholder meeting, do you have details about which civil society groups, academics, business interests, policy watchdogs, and other interested parties will be invited and when it will take place?

The consultation workshop held in 2007 had representation from a wide range of stakeholders including several industry associations and small and medium enterprises (SMEs), environmental and health NGOs as well as Canadian university researchers. Regulatory authorities from other jurisdictions and other Canadian federal government departments were also part of the consultative process. For future consultations, stakeholder participation will consist of similar representation and will also include other identified interested parties as nanotechnology activity in Canada increases.

Q8 – Is there a launch date (as opposed to the vague Spring 2010) for the proposed NanoPortal mentioned in the OECD report (no. 20, Feb. 2010) of the Working Party on Nanomaterials?

Health Canada’s NanoPortal is at the last stage of development. Health Canada is now working on the final details and will provide a launch date in the near future.

Thank you Ms. Legault for providing answers to my questions.

Plot to bomb IBM nanotech facility in Switzerland

There aren’t many details so I’m not sure how solid this information is but it seems that a small group of one woman and two men were arrested. April 15, 2010, in an apparent plot to bomb an IBM nanotech facility being built in Rueschlikon (near Zurich). You can read slightly more here. The news seems to have been broken just hours ago.