Posts Tagged ‘Environment Canada’

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Canada-US Regulatory Cooperation Council’s Nanotechnology Work Plan

Monday, December 3rd, 2012

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

…

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

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

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

Agriculture and Food, Session A

  • Perimeter approach to plant protection

Agriculture and Food, Session B

  • Crop protection products

Agriculture and Food, Session C

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

Agriculture and Food, Session D

  • Veterinary drugs
  • Zoning for foreign animal disease

Agriculture and Food, Session E

  • Financial protection to produce sellers

Agriculture and Food, Session F

  • Food safety – common approach
  • Food safety – testing

Road Transport – Motor Vehicles

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

Air Transport

  • Unmanned aircraft

Transportation

  • Intelligent Transportation Systems

Transportation

  • Dangerous goods means of transportation

Marine Transport

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

Rail Transport

  • Locomotive Emissions
  • Rail Safety Standards

Environment

  • Emission standards for light-duty vehicles

Personal Care Products & Pharmaceuticals

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

Occupational Safety Issues

  • Classification & labelling of workplace hazardous chemicals

Nanotechnology

  • Nanotechnology

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

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

Nanotechnology Work Plan

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

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

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

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

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

3-6 months:

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

6-12 months:

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

12-18 months:

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

18th month:

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

Beyond 18 months:

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

Workplan for Industrial Nanomaterials

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

1-3 months:

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

3-6 months:

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

8th month:

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

6-12 months:

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

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

12th month:

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

12-18 months:

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

15th month:

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

…

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

Canada

(Lead) Karen Dodds, Assistant Deputy Minister, Science and Technology, Environment Canada (karen.dodds@ec.gc.ca; ph. 613- 819-934-6851)

Hilary Geller, Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch (hilary.geller@hc-sc.gc.ca; ph. 613-946-6701)

United States

(Lead) Margaret Malanoski, Office of Management and Budget (Margaret_A._Malanoski@omb.eop.gov)

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

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Posted in nanotechnology, regulation, risk | No Comments »

Trent University (Ontario, Canada) and nanosilver toxicology studies

Thursday, May 3rd, 2012

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Posted in environment, health and safety, nanotechnology, risk | 3 Comments »

One more muzzle for Canadian government scientists

Thursday, September 16th, 2010

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,

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?

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Posted in science communication, science policy | 2 Comments »

Regulating nanomaterials according to the US GAO and EPA

Thursday, July 8th, 2010

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

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

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

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

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

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

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

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

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

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

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

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

There’s more than one way to be exposed,

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

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

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

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

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

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

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

…

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

Compare,

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

…

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

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

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

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

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

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

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

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Posted in nanotechnology, regulation | No Comments »

Synthetic biology: commercialization, Canadian farmers, and public discourse

Monday, May 24th, 2010

You may see synthetic biology (or more properly a synthetic organism) referred to as ‘Synthia’. The term was coined (or, for some word play, created) by the ETC Group as they note in their May 20, 2010 news release about J. Craig Venter’s latest accomplishment (noted on this blog here and here),

The construction of this synthetic organism, anticipated and dubbed “Synthia” by the ETC Group three years ago, will stir a firestorm of controversy over the ethics of building artificial life and the implications of the largely unknown field of synthetic biology.

Clearly the ETC Group, which is based in Canada, has been gearing up for a campaign. It’ll be interesting to note whether or not they are successful at making ‘Synthia’ stick. I gather the group was able to capitalize on ‘frankenfoods’ for the campaign on genetically modified foods but someone else coined that phrase for them. (You can read about who coined the phrase in Susan Tyler Hitchcock’s book, Frankenstein; a cultural history.)

The advantage with ‘frankenfoods’ is the reference to an internationally recognized cultural icon, Frankenstein, and all of the associations that naturally follow. With ‘Synthia’, the ETC Group will have to build (link? graft?) the references to/onto the term.

I shouldn’t forget that the ETC Group does make an important point with this,

The team behind today’s announcement, led by controversial scientist and entrepreneur Craig Venter, is associated with a private company, Synthetic Genomics Inc, bankrolled by the US government and energy behemoths BP and Exxon. Synthetic Genomics recently announced a $600 million research and investment deal with Exxon Mobil in addition to a 2007 investment from BP for an undisclosed amount. Venter, who led the private sector part of the human genome project ten years ago, has already applied for patents related to Synthia’s technology.

In a possibly related (to the ETC Group) statement, the National Farmers Union (NFU) had this to say (from the May 22, 2010 news item on CBC News),

The National Farmers Union says the development of a synthetic cell could lead to worrisome, long-term consequences.

…

“This new technology raises serious concerns about who controls it, what it will be used for, and its potential impact,” [Terry] Boehm [president, NFU] said.

There are two things I want to note. First, the concerns raised by the ETC Group, the NFU, and others in Canada and across the globe are important and require discussion. Second, all of the parties involved business interests, civil society groups, scientists, government agencies, etc. work independently and together (formally and informally) to promote their interests.

In a related note: In a May 23, 2010 CBC news item (published on Sunday during a long weekend),

The government is looking for ways to monitor online chatter about political issues and correct what it perceives as misinformation.

The move started recently with a pilot project on the East Coast seal hunt. A Toronto-based company called Social Media Group has been hired to help counter some information put forward by the anti-sealing movement.

The Department of Foreign Affairs and International Trade has paid the firm $75,000 “to monitor social activity and help identify … areas where misinformation is being presented and repeated as fact,” Simone MacAndrew, a department spokesperson, said in an email.

…

The firm alerts the government to questionable online comments and then employees in Foreign Affairs or the Department of Fisheries and Oceans, who have recently been trained in online posting, point the authors to information the government considers more accurate.

It appears to be just the beginning. [emphases mine]

(Digression alert! Does this mean I’ll be able to easily get more information about nanotechnology research in Canada, about the national institute, about nanomaterials, about proposed regulatory frameworks, etc.?)

I have to admit to being suspicious about this ‘information initiative’ when the announcement appears to have been made in an email during a holiday weekend. As well, it seems a bit schizoid given the government’s ban (I’ve commented about that here) on direct communication between journalists and scientists working for Environment Canada. So, the government will contact us if they think we have it wrong but a journalist can’t directly approach one of their scientists to ask a question.

Returning to my main focus, the impact that all these groups with their interests, by turns competitive and collegial, will have on the synthetic biology debate is impossible to evaluate at this time. It does seem that much of the framing for the discussion has been predetermined by various interest groups while the rest of us have remained in relative ignorance. I think the ‘pre-framing’ is inevitable given that most of us would not be interested in engaging in a discussion about developments which were largely theoretical, until recently.

For those who are interested in learning about the science and the debates, check out the Oscillator here. She notes that we’ve had some parts of this discussion as early as the 19th century,

My ScienceBlogs colleague PZ Myers compares the synthetic genome to Wöhler’s chemical synthesis of urea in 1828. In the 19th century, scientists debated whether or not the chemicals that make up living cells–organic chemistry–had to be made by a cell possessing a “vital spark” or could be made by humans in a test tube. By synthesizing urea from ammonium cyanate, Wöhler broke down some of the mysticism associated with living cells. From that point on, organic chemistry stopped being magic and became a science.

Does the Venter Institute’s achievement show that life is just chemicals? I don’t think so …

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Posted in science, science communication, science policy | 2 Comments »

Comparing nanomaterials definitions: US and Canada

Tuesday, April 27th, 2010

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.

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Posted in environment, health and safety, nanotechnology, regulation | 7 Comments »

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

Monday, April 26th, 2010

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.

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Posted in nanotechnology, science communication, science policy | 8 Comments »

Peter Julian’s interview about proposing Canada’s first nanotechnology legislation (part 2 of 3); more on the UK Nanotechnologies Strategy; Dylan Thomas, neuroscience and an open reading

Thursday, March 25th, 2010

This is part 2 of an interview with Member of Parliament, Peter Julian, NDP (New Democrat Party) who tabled the first Canadian bill to regulate nanotechnology. Yesterday’s part of the interview featured some biographical notes about Mr. Julian and his answers to questions about why he, in particular, tabled the bill; the NDP’s shadow science minister’s (Jim Malloway) involvement; and the NDP’s commitment to science policy. Today, Julian explains why he favours the application of the precautionary principle to nanotechnology, notes the research he used before writing his bill, and comments on a national inventory scheme. NOTE: As some folks may prefer other media or summaries/commentaries on these reports, in situations where I have additional material, I’ve taken the liberty of giving links, clearly marking my additions.

Why do you favour applying the precautionary principle which has received some criticism as it favours the status quo?

I believe that the precautionary principle does not favour the status quo. The status quo hinders appropriate applications of precaution. Environmental, health, and safety gaps in the application of Nanotechnology are a shared concern between countries, as reflected in recent reports to Congress and the EU and at the OECD. Precaution towards discovery, product, production, use and eventual disposal is simple common sense.

The precautionary principle deters action without reflection. When a product is massively put on the market we have to be sure that it will not have adverse effects on health and the environment, and not just a short lived positive effect on the bottom line.

What research materials support your (BILL) and are these materials that you would recommend interested citizens read?

I have a list of links concerning these materials:

ED. NOTE:  I offered some commentary here and links to other commentaries here about this report.

  • The Chatham House briefing paper, Regulating Nanomaterials: A Transatlantic Agenda (September 2009) an excellent eight page read:

http://www.chathamhouse.org.uk/publications/papers/view/-/id/774/

ED. NOTE: There is a Project on Emerging Nanotechnologies (PEN)webcast of a presentation by the folks who authored the report. The webcast and speaker presentations can be found here and my commentary on the webcast here.

ED. NOTE: PEN webcast a presentation by J. Clarence Davies on Oversight of Next Generation Nanotechnology available here along with a speaker’s presentation and additional materials.

  • The National Nanotechnology Initiative document lays out a substantive, and sound, research program. Canada’s strategy remains limited in scope and vision.

http://www.nano.gov/NNI_EHS_Research_Strategy.pdf

I noticed mention of a public inventory for nanomaterials and it reminded me of a proposed Environment Canada nanomaterials inventory or reporting plan that was announced in January 2008. Do you know if this inventory ever took place or what its current status is?

The inventory is not completed yet. The bill develops a mandatory requirement for an inventory and there have been no prior operational inventories regarding nanotechnology products, which is why this bill is so important.

I would like to stress that in addition to the precautionary principle, Bill C-494 is built on a definition of Nanotechnology that adopts a broader and more inclusive definition of nanomaterials. This is consistent with the findings of the UK House of Lords Science and Technology Committee:

  • We recommend that the Government should work towards ensuring that any regulatory definition of nanomaterials proposed at a European level, in particular in the Novel Foods Regulation, should not include a size limit of 100nm but instead refer to ‘the nanoscale’ to ensure that all materials with a dimension under 1000nm are considered.A change in functionality, meaning how a substance interacts with the body, should be the factor that distinguishes a nanomaterial from its larger form within the nanoscale.

UK House of Lords Science and Technology Committee
Nanotechnologies and Food (8 January 2010)
Recommendation 12, p.76

http://www.publications.parliament.uk/pa/ld/ldsctech.htm

This is in contrast with Health Canada policy which looks at narrow definition of nanomaterials:

  • Health Canada’s Science Policy Directorate announced the adoption of the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials and its posting on the Health Canada website 2 March 2010. This Government of Canada policy adopts a 1-100nm “inclusive” regulatory benchmark, effective immediately, with a public comment period underway.

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

ED. NOTE: I made an error in my question, the proposed nano inventory by Environment Canada was announced in Jan. 2009. My postings on the announcement are here and here. The odd thing about the announcement was that it was made initially by PEN which is located in Washington, DC and subsequently picked up by Canadian news media. As far as I know, Environment Canada has never offered comment about its 2009 plan for a nanotechnology inventory.

Tomorrow Julian wraps up with answers to questions about why someone who’s shadow portfolio includes international trade is interested in nanotechnology and the potential costs for his proposed legislation.

Peter Julian interview Part 1, Part 3, Comments: Nano Ontario, Comments: nanoAlberta

More on the UK 2010 Nanotechnologies Strategy Report

Dexter Johnson over on Nanoclast has done some detective work in a bid to understand why the market numbers used in the report differ wildly from anyone else’s. From Dexter’s posting,

It [the report] quotes market numbers for nano-enabled products that are such a drastic departure from most estimates that it leaves one questioning why tens of billions of dollars are being poured in by governments around the world to fund research.

If you have it, do take the time to follow along as Dexter  trails the company that the UK government used as its source for their market numbers. Amongst other names, I recognized one, ObservatoryNANO. (It was an organization I followed briefly and dismissed as being frivolous.)

One other commenter has emerged, Tim Harper. Now as the  principle of a nanotechnology business consulting company (Cientifica) some might be inclined to dismiss his comments but they have the ring of honest frustration and a sincere desire to contribute. From Harper’s posting,

Every UK nanotech report to date has excluded any data provided by UK companies. Even offers of free copies of our market research to government committees looking into various bits of nanotechnology provoke the same response as if we’d offered them a fresh dog turd wrapped in newspaper.

And now for a complete change of pace,

Dylan Thomas and neuroscience

There‘s an event tonight  (Thursday, March 25, 2010) in Vancouver being put on by the Dylan Thomas Circle (he lived in North Vancouver for a time as he worked on Under the volcano). It’s being held at the Red Dragon Pub at the Cambrian Hall on 17th & Main St.  Doors open at 6:45 pm and the presentation starts at 7:30 pm followed by an open reading. From the news release,

THE DYLAN THOMAS CIRCLE OF VANCOUVER presents

“Dylan Thomas, Creativity and Neuroscience”

Ariadne Sawyer will lead an exploration into creativity and the creative process as manifest through the works and the life of Dylan Thomas. She will investigate why we are creative, what happens during the creative process and what effect it has upon us.

This will be followed by an intermission and an: ‘OPEN READING’: an invitation to everyone who is interested to read aloud a poem or literary excerpt of their choice. This can be your own work, Dylan’s work or any other writer’s material. Most importantly, it is our chance to indulge in a little of our own creativity and to do it in a relaxed and in a friendly atmosphere.

About Ariadne Sawyer:

Ariadne has done on line Performance Plus Coaching with trainees from England, France, Canada and the United States for the last two years. She has received the Award of Excellence given by McLean-Hunter for the Brain Bulletin Series. Ariadne publishes an electronic newsletter called: Ariadne’s Performance Plus Newsletter along with Performance Plus Tips which are sent to all the participating trainees. She also co-hosts a weekly radio program on CFRO 102.7 FM, which has been on the air for the past two years. The Performance Plus Mini Course has been presented on the show with astounding success. She has two electronic courses available soon on the Internet. Performance Plus Level One and the Performance Plus Diplomacy Course. Ariadne has worked with trainees from Europe, the US and across Canada.

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Posted in interviews, nanotechnology, performing arts, regulation, writing | 5 Comments »

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