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Nanomaterials, nanomedicines and nanodefinitions

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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 nanotechnologies@hc-sc.gc.ca.

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).

Misunderstanding the data or a failure to research? Georgia Straight article about nanoparticles

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It’s good to see articles about nanotechnology. The recent, Tiny nanoparticles could be a big problem, article written by Alex Roslin for the Georgia Straight (July 21, 2011 online or July 21-28, 2011 paper edition) is the first I’ve seen on that topic in that particular newspaper. Unfortunately, there are  some curious bits of information included in the article, which render it, in my opinion, difficult to trust.

I do agree with Roslin that nanoparticles/nanomaterials could constitute a danger and there are a number of studies which indicate that, at the least, extreme caution in a number of cases should be taken if we choose to proceed with developing nanotechnology-enabled products.

One of my difficulties with the article is the information that has been left out. (Perhaps Roslin didn’t have time to properly research?) At the time (2009) I did read with much concern the reports Roslin mentions about the Chinese workers who were injured and/or died after working with nanomaterials. As Roslin points out,

Nanotech already appears to be affecting people’s health. In 2009, two Chinese factory workers died and another five were seriously injured in a plant that made paint containing nanoparticles.

The seven young female workers developed lung disease and rashes on their face and arms. Nanoparticles were found deep in the workers’ lungs.

“These cases arouse concern that long-term exposure to some nanoparticles without protective measures may be related to serious damage to human lungs,” wrote Chinese medical researchers in a 2009 study on the incident in the European Respiratory Journal.

Left undescribed by Roslin are the working conditions; the affected people were working in an unventilated room. From the European Respiratory Journal article (ERJ September 1, 2009 vol. 34 no. 3 559-567, free access), Exposure to nanoparticles is related to pleural effusion, pulmonary fibrosis and granuloma,

A survey of the patients’ workplace was conducted. It measures ∼70 m2, has one door, no windows and one machine which is used to air spray materials, heat and dry boards. This machine has three atomising spray nozzles and one gas exhauster (a ventilation unit), which broke 5 months before the occurrence of the disease. The paste material used is an ivory white soft coating mixture of polyacrylic ester.

Eight workers (seven female and one male) were divided into two equal groups each working 8–12 h shifts. Using a spoon, the workers took the above coating material (room temperature) to the open-bottom pan of the machine, which automatically air-sprayed the coating material at the pressure of 100–120 Kpa onto polystyrene (PS) boards (organic glass), which can then be used in the printing and decorating industry. The PS board was heated and dried at 75–100°C, and the smoke produced in the process was cleared by the gas exhauster. In total, 6 kg of coating material was typically used each day. The PS board sizes varied from 0.5–1 m2 and ∼5,000 m2 were handled each workday. The workers had several tasks in the process including loading the soft coating material in the machine, as well as clipping, heating and handling the PS board. Each worker participated in all parts of this process.

Accumulated dust particles were found at the intake of the gas exhauster. During the 5 months preceding illness the door of the workspace was kept closed due to cold outdoor temperatures. The workers were all peasants near the factory, and had no knowledge of industrial hygiene and possible toxicity from the materials they worked with. The only personal protective equipment used on an occasional basis was cotton gauze masks. According to the patients, there were often some flocculi produced during air spraying, which caused itching on their faces and arms. It is estimated that the airflow or turnover rates of indoor air would be very slow, or quiescent due to the lack of windows and the closed door. [emphases mine]

Here’s the full text from the researchers’ conclusion,

In conclusion, these cases arouse concern that long-term exposure to some nanoparticles without protective measures may be related to serious damage to human lungs. It is impossible to remove nanoparticles that have penetrated the cell and lodged in the cytoplasm and caryoplasm of pulmonary epithelial cells, or that have aggregated around the red blood cell membrane. Effective protective methods appear to be extremely important in terms of protecting exposed workers from illness caused by nanoparticles.

There is no question that serious issues about occupational health and safety with regards to nanomaterials were raised. But, we work with dangerous and hazardous materials all the time; precautions are necessary whether you’re working with hydrochloric acid or engineered nanoparticles. (There are naturally occurring nanoparticles too.)

Dr. Andrew Maynard (at the time he was the Chief Science Advisor for the Project on Emerging Nanotechnologies, today he is the Director of the University of Michigan’s Risk Science Center) on his 2020 Science blog wrote a number of posts dated Aug. 18, 2009 about this tragic industrial incident, including this one where he culled comments from six other researchers noting some of the difficulties the Chinese researchers experienced running a clinical study after the fact.

The material on silver nanoparticles and concerns about their use in consumer products and possible toxic consequences with their eventual appearance in the water supply seem unexceptionable to me. (Note:  I haven’t drilled down into the material and the writer cites studies unknown to me but they parallel information I’ve seen elsewhere).

The material on titanium dioxide as being asbestos-like was new to me, the only nanomaterial I’d previously heard described as being similar to asbestos is the long carbon nanotube. I am surprised Roslin didn’t mention that occupational health and safety research which is also quite disturbing, it’s especially surprising since Roslin does mention carbon nanotubes later in the article.

There is a Canadian expert, Dr. Claude Ostiguy, who consults internationally on the topic of nanotechnology and occupational health and safety. I wonder why he wasn’t consulted. (Note: He testified before Canada’s House of Commons Standing Committee on Health meeting in June 2010 on this topic. You can find more about this in my June 23, 2011 posting, Nanomaterials, toxicity, and Canada’s House of Commons Standing Committee on Health.)

Quoted quite liberally throughout the article is researcher, Dr.Robert Schiestl (professor of pathology and radiation oncology at the University of California at Los Angeles [UCLA]). This particular passage referencing Schiestl is a little disconcerting,

Schiestl said nanoparticles could also be helping to fuel a rise in the rates of some cancers. He wouldn’t make a link with any specific kind of cancer, but data from the U.S. National Cancer Institute show that kidney and renal-pelvis cancer rates rose 24 percent between 2000 and 2007 in the U.S., while the rates for melanoma of the skin went up 29 percent and thyroid cancer rose 54 percent.

Since Schiestl isn’t linking the nanoparticles to any specific cancers, why mention those statistics? Using that kind of logic I could theorize that the increase in the number and use of cell phones (mobiles) may have something to do with these cancers. Perhaps organic food has caused this increase? You see the problem?

As for the number of nanotechnology-enabled products in use, I’m not sure why Roslin chose to cite the Project on Emerging Nanotechnologies’ inventory which is not scrutinized, i. e., anyone can register any product as nanotechnology-enabled. The writer also mentioned a Canadian inventory listing over 1600 products  cited in an ETC Group report, The Big Downturn? Nanogeopolitics,

Has anyone ever seen this inventory? I’ve been chasing it for years and the only time the Canadian government reports on this inventory is in the Organization for Economic Cooperation and Development (OECD) report (cited by the ETC Group [no. 79 in their list of references] and noted in both my Feb. 1, 2011 posting and my April 12, 2010 posting). Here’s the OECD report, if you’d like to see it for yourself. The top three questions I keep asking myself is where is the report/inventory, how did they determine their terms of reference, and why don’t Canadian taxpayers have easy access to it? I’d best return to my main topic.

As for the material Roslin offers about nanosunscreens I was surprised given the tenor of the article to see that the Environmental Working Group (EWG) was listed as an information source since they recommend mineral sunscreens containing nanoscale ingredients such as titanium dioxide and/or zinc oxide as preferable to sunscreens containing hormone disruptors.  From the EWG page on sunscreens and nanomaterials,

Sunscreen makers offer mineral and non-mineral formulations, as well as products that combine both mineral and non-mineral active ingredients. Mineral formulations incorporate zinc oxide or titanium dioxide in nano- and micro-sized particles that can be toxic if they penetrate the skin. Most studies show that these ingredients do not penetrate through skin to the bloodstream, but research continues. These constitute one in five sunscreens on the market in 2010 and offer strong UVA protection that is rare in non-mineral sunscreens.

The most common ingredients in non-mineral sunscreens are oxybenzone, octisalate, octinoxate, and avobenzone found in 65, 58, 57, and 56 percent of all non-mineral sunscreens on the market, respectively. The most common, oxybenzone, can trigger allergic reactions, is a potential hormone disruptor and penetrates the skin in relatively large amounts. Some experts caution that it should not be used on children. Three of every five sunscreens rated by EWG are non-mineral, and one in five sunscreens combines both mineral and non-mineral active ingredients.

EWG reviewed the scientific literature on hazards and efficacy (UVB and UVA protection) for all active ingredients approved in the U.S. Though no ingredient is without hazard or perfectly effective, on balance our ratings tend to favor mineral sunscreens because of their low capacity to penetrate the skin and the superior UVA protection they offer. [emphasis mine]

(I did find some information (very little) about Health Canada and sunscreens which I discuss in June 3, 2011 posting [if you’re impatient, scroll down about 1/2 way].)

There was some mention of Health Canada in Roslin’s article but no mention of last year’s public consultation, although to be fair, it seemed a clandestine operation. (My latest update on the Health Canada public consultation about a definition for nanomaterials is May 27, 2011.)

I find some aspects of the article puzzling as Roslin is an award-winning investigative reporter. From the kitco bio page,

Alex Roslin is a leading Canadian investigative journalist and active trader based in Montreal. He has won a Canadian Association of Journalists award for investigative reporting and is a five-time nominee for investigative and writing prizes from the CAJ and the National Magazine Awards. He has worked on major investigations for Canada’s premier investigative television program, the fifth estate, and the CBC’s Disclosure program. His writing has appeared in Technical Analysis of Stocks & Commodities, The Financial Post, Toronto Star and Montreal Gazette. He regularly writes about investing for The Montreal Gazette.

I notice there’s no mention of writing in either science or health matters so I imagine this is an early stage piece in this aspect of Roslin’s career, which may explain some of the leaps in logic and misleading information. Happily, I did learn a few things from reading the article and while I don’t trust much of the information in it, I will investigate further as time permits.

In general, I found the tenor of the article more alarmist than informational and I’m sorry about that as I would like to see more information being shared and, ultimately, public discussion in Canada about nanotechnology and other emerging technologies.

Nano regulatory frameworks are everywhere!

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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.

Canada’s plans for nanosunscreens mentioned at Europe’s Nanotechnology Safety for Success Dialogue and sunscreens in Australia

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I posted (April 14, 2011) about the March 29 – 30, 2011 Nanotechnology Safety for Success Dialogue which took place in Brussels (Belgium). I took note of a fierce debate over a nanomaterials definition. (The debate was whether there should be an interim definition or if they should wait until they had enough information to create a finalized definition.

Thankfully a reader has recently redirected my attention to this meeting as I had failed to notice that Canada made a presentation at the meeting. Consequently, I have found more information about Canada’s nanotechnology activities as they pertain to safety through an international organization. (I have searched the Health Canada website and the Canadian federal nanoportal and am unable to locate this presentation on either site.)

The presentation (all 15 slides) was given by Ratna Bose, Ph. D., Manager, Nonprescription Drugs Evaluation Division; Bureau of Gastroenterology, Infection, and Viral Diseases; Therapeutic Products Directorate. There is a Health Portfolio Nanotechnology WG (I imagine this means working group). Here’s how the portfolio is organized and managed (from slide #3),

• Chaired by Science Policy Directorate
• Co-ordinates activities and facilitates information sharing on nanotechnology and nanomaterials within HC
• Includes representatives from Directorates regulating nanomaterials
• Each Directorate is responsible for policies and guidances specific to their respective jurisdiction

Here are the products Health Canada regulates (from slide #5),

Health Canada Regulated Products that May Contain Nanotechnology

• Drugs
• Medical devices
• Biotechnology products
• Tissue engineering products
• Vaccines
• Natural Health products
• Food Ingredients, packaging, manufacturing process

I notice that the head states that the products may contain nanotechnology, which seems odd. They might contain nanomaterial(s) and/or be nanotechnology-enabled but they can’t contain nanotechnology in the same way they contain biology. Plus, I thought Agriculture Canada regulated food (I will check this out).

This is what they are proposing for future work (from slide #12),

Regulatory Perspective
Develop standardized risk assessment methods
Develop regulatory, product-specific guidance documents
Build regulatory capacity/expertise

Scientific Perspective
Continue participation in international activities (e.g., ISO, OECD)
Explore collaborative work to develop methodologies to detect, characterize and measure NMs by working with industry as well as domestic and international partners

Awareness Perspective
Develop public engagement and risk communication strategies
Engage industry stakeholders

Under Awareness Perspective they’ve linked public engagement and risk communication together. Is risk communication the only reason they’re planning public engagement?

The slides indicate that there will be a case study developed around nanosunscreens. From slides 13 & 14,

Sunscreens are regulated as drugs in Canada, subject to either the Food and Drug Regulations or the Natural Health Product Regulations depending on the active ingredient and claim.

The Sunburn Protectants Monograph outlines active ingredients and their concentrations, as well as appropriate warnings, directions for use, and claims which are generally considered to be safe and effective.

The nanomaterial based sunscreens are excluded from the Sunburn Protectants monograph.

In order to satisfy the Safety & Effectiveness requirements of the Regulations, safety data are being requested.

I wonder where the safety data is coming from?

Meanwhile, there was a May 23, 2011 post by Dr. Andrew Maynard on the University of Michigan’s Risk Science Blog about a recent nanosunscreen event in Australia. From the posting,

Last week, the Victoria branch of the Australian Education Union (AEU) passed a resolution recommending that “workplaces use only nanoparticle-free sunscreen” and that sunscreens used by members on children are selected from those “highlighted in the Safe Sunshine Guide produced by Friends of the Earth” as being nano-free. The AEU also resolved to provide the Friends of the Earth Safe Sunscreen Guide and Recommendations to all workplaces their members are associated with. Given what is currently known about sunscreens – nano and otherwise, I can’t help wonder whether this is an ill-advised move.

The debate over the safety or otherwise of nanoparticle-containing sunscreens has been going on for over a decade now. Prompted by early concerns over possible penetration through the skin and into the body of the nanosized titanium dioxide and/or zinc oxide particles used in these products – and potential adverse impacts that might result – there has been a wealth of research into whether these small particles can actually get through the skin when applied in a sunscreen. And the overall conclusion is that they cannot. There have been a small number of studies that demonstrate that, under specific conditions, some types of nanoparticle might penetrate through the upper layers of the skin. But the overwhelming majority of studies have failed to find either plausible evidence for significant penetration, or plausible evidence for adverse health impacts [emphasis mine] – a body of evidence that led the Environmental Working Group to make an about-face from questioning the use of nanoparticle-containing sunscreens to endorsing them in 2010.

If you’re interested in the nanosunscreen discussion, I highly recommend Andrew’s writing on the subject, the report by the Environmental Working Group, and the report by the Friends of the Earth for a comprehensive view of the discussion.

As for me, I believe, given the information at hand, that nanosunscreens are relatively safe for most adults and I reserve the right to change my opinion should new information emerge. Meanwhile, I look forward to learning more about Health Canada’s nanotechnology safety efforts and hope that one day the information will be easily accessible on the Health Canada website or the federal nanoportal. Who knows maybe there’ll be a public engagement exercise on the topic of nanosunscreens?

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

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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

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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

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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).

One more muzzle for Canadian government scientists

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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?