Tag Archives: GAO

Competition, collaboration, and a smaller budget: the US nano community responds

Before getting to the competition, collaboration, and budget mentioned in the head for this posting, I’m supplying some background information.

Within the context of a May 20, 2014 ‘National Nanotechnology Initiative’ hearing before the U.S. House of Representatives Subcommittee on Research and Technology, Committee on Science, Space, and Technology, the US General Accountability Office (GAO) presented a 22 pp. précis (PDF; titled: NANOMANUFACTURING AND U.S. COMPETITIVENESS; Challenges and Opportunities) of its 125 pp. (PDF version report titled: Nanomanufacturing: Emergence and Implications for U.S. Competitiveness, the Environment, and Human Health).

Having already commented on the full report itself in a Feb. 10, 2014 posting, I’m pointing you to Dexter Johnson’s May 21, 2014 post on his Nanoclast blog (on the IEEE [Institute of Electrical and Electronics Engineers] website) where he discusses the précis from the perspective of someone who was consulted by the US GAO when they were writing the full report (Note: Links have been removed),

I was interviewed extensively by two GAO economists for the accompanying [full] report “Nanomanufacturing: Emergence and Implications for U.S. Competitiveness, the Environment, and Human Health,” where I shared background information on research I helped compile and write on global government funding of nanotechnology.

While I acknowledge that the experts who were consulted for this report are more likely the source for its views than I am, I was pleased to see the report reflect many of my own opinions. Most notable among these is bridging the funding gap in the middle stages of the manufacturing-innovation process, which is placed at the top of the report’s list of challenges.

While I am in agreement with much of the report’s findings, it suffers from a fundamental misconception in seeing nanotechnology’s development as a kind of race between countries. [emphases mine]

(I encourage you to read the full text of Dexter’s comments as he offers more than a simple comment about competition.)

Carrying on from this notion of a ‘nanotechnology race’, at least one publication focused on that aspect. From the May 20, 2014 article by Ryan Abbott for CourthouseNews.com,

Nanotech Could Keep U.S. Ahead of China

WASHINGTON (CN) – Four of the nation’s leading nanotechnology scientists told a U.S. House of Representatives panel Tuesday that a little tweaking could go a long way in keeping the United States ahead of China and others in the industry.

The hearing focused on the status of the National Nanotechnology Initiative, a federal program launched in 2001 for the advancement of nanotechnology.

As I noted earlier, the hearing was focused on the National Nanotechnology Initiative (NNI) and all of its efforts. It’s quite intriguing to see what gets emphasized in media reports and, in this case, the dearth of media reports.

I have one more tidbit, the testimony from Lloyd Whitman, Interim Director of the National Nanotechnology Coordination Office and Deputy Director of the Center for Nanoscale Science and Technology, National Institute of Standards and Technology. The testimony is in a May 21, 2014 news item on insurancenewsnet.com,

Testimony by Lloyd Whitman, Interim Director of the National Nanotechnology Coordination Office and Deputy Director of the Center for Nanoscale Science and Technology, National Institute of Standards and Technology

Chairman Bucshon, Ranking Member Lipinski, and Members of the Committee, it is my distinct privilege to be here with you today to discuss nanotechnology and the role of the National Nanotechnology Initiative in promoting its development for the benefit of the United States.

Highlights of the National Nanotechnology Initiative

Our current Federal research and development program in nanotechnology is strong. The NNI agencies continue to further the NNI’s goals of (1) advancing nanotechnology R&D, (2) fostering nanotechnology commercialization, (3) developing and maintaining the U.S. workforce and infrastructure, and (4) supporting the responsible and safe development of nanotechnology. …

,,,

The sustained, strategic Federal investment in nanotechnology R&D combined with strong private sector investments in the commercialization of nanotechnology-enabled products has made the United States the global leader in nanotechnology. The most recent (2012) NNAP report analyzed a wide variety of sources and metrics and concluded that “… in large part as a result of the NNI the United States is today… the global leader in this exciting and economically promising field of research and technological development.” n10 A recent report on nanomanufacturing by Congress’s own Government Accountability Office (GAO) arrived at a similar conclusion, again drawing on a wide variety of sources and stakeholder inputs. n11 As discussed in the GAO report, nanomanufacturing and commercialization are key to capturing the value of Federal R&D investments for the benefit of the U.S. economy. The United States leads the world by one important measure of commercial activity in nanotechnology: According to one estimate, n12 U.S. companies invested $4.1 billion in nanotechnology R&D in 2012, far more than investments by companies in any other country.  …

There’s cognitive dissonance at work here as Dexter notes in his own way,

… somewhat ironically, the [GAO] report suggests that one of the ways forward is more international cooperation, at least in the development of international standards. And in fact, one of the report’s key sources of information, Mihail Roco, has made it clear that international cooperation in nanotechnology research is the way forward.

It seems to me that much of the testimony and at least some of the anxiety about being left behind can be traced to a decreased 2015 budget allotment for nanotechnology (mentioned here in a March 31, 2014 posting [US National Nanotechnology Initiative’s 2015 budget request shows a decrease of $200M]).

One can also infer a certain anxiety from a recent presentation by Barbara Herr Harthorn, head of UCSB’s [University of California at Santa Barbara) Center for Nanotechnology in Society (CNS). She was at a February 2014 meeting of the Presidential Commission for the Study of Bioethical Issues (mentioned in parts one and two [the more substantive description of the meeting which also features a Canadian academic from the genomics community] of my recent series on “Brains, prostheses, nanotechnology, and human enhancement”). II noted in part five of the series what seems to be a shift towards brain research as a likely beneficiary of the public engagement work accomplished under NNI auspices and, in the case of the Canadian academic, the genomics effort.

The Americans are not the only ones feeling competitive as this tweet from Richard Jones, Pro-Vice Chancellor for Research and Innovation at Sheffield University (UK), physicist, and author of Soft Machines, suggests,

May 18

The UK has fewer than 1% of world patents on graphene, despite it being discovered here, according to the FT –

I recall reading a report a few years back which noted that experts in China were concerned about falling behind internationally in their research efforts. These anxieties are not new, CP Snow’s book and lecture The Two Cultures (1959) also referenced concerns in the UK about scientific progress and being left behind.

Competition/collaboration is an age-old conundrum and about as ancient as anxieties of being left behind. The question now is how are we all going to resolve these issues this time?

ETA May 28, 2014: The American Institute of Physics (AIP) has produced a summary of the May 20, 2014 hearing as part of their FYI: The AIP Bulletin of Science Policy News, May 27, 2014 (no. 93).

ETA Sept. 12, 2014: My first posting about the diminished budget allocation for the US NNI was this March 31, 2014 posting.

‘Valley of Death’, ‘Manufacturing Middle’, and other concerns in new government report about the future of nanomanufacturing in the US

A Feb. 8, 2014 news item on Nanowerk features a US Government Accountability Office (GAO) publication announcement (Note:  A link has been removed),

In a new report on nanotechnology manufacturing (or nanomanufacturing) released yesterday (“Nanomanufacturing: Emergence and Implications for U.S. Competitiveness, the Environment, and Human Health”; pdf), the U.S. Government Accountability Office finds flaws in America’s approach to many things nano.

At a July 2013 forum, participants from industry, government, and academia discussed the future of nanomanufacturing; investments in nanotechnology R&D and challenges to U.S. competitiveness; ways to enhance U.S. competitiveness; and EHS concerns.

A summary and a PDF version of the report, published Jan. 31, 2014, can be found here on the GAO’s GAO-14-181SP (report’s document number) webpage.  From the summary,

The forum’s participants described nanomanufacturing as a future megatrend that will potentially match or surpass the digital revolution’s effect on society and the economy. They anticipated further scientific breakthroughs that will fuel new engineering developments; continued movement into the manufacturing sector; and more intense international competition.

Although limited data on international investments made comparisons difficult, participants viewed the U.S. as likely leading in nanotechnology research and development (R&D) today. At the same time, they identified several challenges to U.S. competitiveness in nanomanufacturing, such as inadequate U.S. participation and leadership in international standard setting; the lack of a national vision for a U.S. nanomanufacturing capability; some competitor nations’ aggressive actions and potential investments; and funding or investment gaps in the United States (illustrated in the figure, below), which may hamper U.S. innovators’ attempts to transition nanotechnology from R&D to full-scale manufacturing.

[downloaded from http://www.gao.gov/products/GAO-14-181SP]

[downloaded from http://www.gao.gov/products/GAO-14-181SP]

I read through (skimmed) this 125pp (PDF version;  119 pp. print version) report and allthough it’s not obvious in the portion I’ve excerpted from the summary or in the following sections, the participants did seem to feel that the US national nanotechnology effort was in relatively good shape overall but with some shortcomings that may become significant in the near future.

First, government investment illustrates the importance the US has placed on its nanotechnology efforts (excerpted from p. 11 PDF; p. 5 print),

Focusing on U.S. public investment since 2001, the overall growth in the funding of nanotechnology has been substantial, as indicated by the funding of the federal interagency National Nanotechnology Initiative (NNI), with a cumulative investment of about $18 billion for fiscal years 2001 through 20133. Adding the request for fiscal year 2014 brings the total to almost $20 billion. However, the amounts budgeted in recent years have not shown an increasing trend.

Next, the participants in the July 2013 forum focused on four innovations in four different industry sectors as a means of describing the overall situation (excerpted from p. 16 PDF; p. 10 print):

Semiconductors (Electronics and semiconductors)

Battery-powered vehicles (Energy and power)

Nano-based concrete (Materials and chemical industries)

Nanotherapeutics (Pharmaceuticals, biomedical, and biotechnology)

There was some talk about nanotechnology as a potentially disruptive technology,

Nanomanufacturing could eventually bring disruptive innovation and the creation of new jobs—at least for the nations that are able to compete globally. According to the model suggested by Christensen (2012a; 2012b), which was cited by a forum participant, the widespread disruption of existing industries (and their supply chains) can occur together with the generation of broader markets, which can lead to net job creation, primarily for nations that bring the disruptive technology to market. The Ford automobile plant (with its dramatic changes in the efficient assembly of vehicles) again provides an historical example: mass – produced automobiles made cheaply enough—through economies of scale—were sold to vast numbers of consumers, replacing horse and buggy transportation and creating jobs to (1) manufacture large numbers of cars and develop the supply chain; (2) retail new cars; and (3) service them. The introduction of minicomputers and then personal computers in the 1980s and 1990s provides another historical example; the smaller computers disrupted the dominant mainframe computing industry (Christensen et al. 2000). Personal computers were provided to millions of homes, and an analyst in the Bureau of Labor Statistics (Freeman 1996) documented the creation of jobs in related areas such as selling home computers and software. According to Christensen (2012b), “[A]lmost all net growth in jobs in America has been created by companies that were empowering—companies that made complicated things affordable and accessible so that more people could own them and use them.”14 As a counterpoint, a recent report analyzing manufacturing today (Manyika et al. 2012, 4) claims that manufacturing “cannot be expected to create mass employment in advanced economies on the scale that it did decades ago.”

Interestingly, there is no mention in any part of the report of the darker sides of a disruptive technology. After all, there were people who were very, very upset over the advent of computers. For example, a student (I was teaching a course on marketing communication) once informed me that she and her colleagues used to regularly clear bullets from the computerized equipment they were sending up to the camps (memory fails as to whether these were mining or logging camps) in northern British Columbia in the early days of the industry’s computerization.

Getting back to the report, I wasn’t expecting to see that one of the perceived problems is the US failure to participate in setting standards (excerpted from p. 23 PDF; p. 17 print),

Lack of sufficient U.S. participation in setting standards for nanotechnology or nanomanufacturing. Some participants discussed a possible need for a stronger role for the United States in setting commercial standards for nanomanufactured goods (including defining basic terminology in order to sell products in global markets).17

The participants discussed the ‘Valley of Death’ and the ‘Missing Middle’ (excerpted from pp. 31-2 PDF; pp. 25-6 print)

Forum participants said that middle-stage funding, investment, and support gaps occur for not only technology innovation but also manufacturing innovation. They described the Valley of Death (that is, the potential lack of funding or investment that may characterize the middle stages in the development of a technology or new product) and the Missing Middle (that is, a similar lack of adequate support for the middle stages of developing a manufacturing process or approach), as explained below.

The Valley of Death refers to a gap in funding or investment that can occur after research on a new technology and its initial development—for example, when the technology moves beyond tests in a controlled laboratory setting.22 In the medical area, participants said the problem of inadequate funding /investment may be exacerbated by requirements for clinical trials. To illustrate, one participant said that $10 million to $20 million is needed to bring a new medical treatment into clinical trials, but “support from [a major pharmaceutical company] typically is not forthcoming until Phase II clinical trials,” resulting in a  Valley of Death for  some U.S. medical innovations. Another participant mentioned an instance where a costly trial was required for an apparently low risk medical device—and this participant tied high costs of this type to potential difficulties that medical innovators might have obtaining venture capital. A funding /investment gap at this stage can prevent further development of a technology.

The term  Missing Middle has been used to refer to the lack of funding/investment that can occur with respect to manufacturing innovation—that is, maturing manufacturing capabilities and processes to produce technologies at scale, as illustrated in figure 8.23 Here, another important lack of support may be the absence of what one participant called an “industrial commons”  to sustain innovation within a  manufacturing sector.24 Logically, successful transitioning across the  middle stages of manufacturing development is a prerequisite to  achieving successful new approaches to manufacturing at scale.

There was discussion of the international scene with regard to the ‘Valley of Death’ and the ‘Missing Middle’ (excerpted from pp. 41-2 PDF; pp. 35-6 print)

Participants said that the Valley of Death and Missing Middle funding and investment gaps, which are of concern in the United States, do not apply to the same extent in some other countries—for example, China and Russia—or are being addressed. One participant said that other countries in which these gaps have occurred “have zeroed in [on them] with a laser beam.” Another participant summed up his view of the situation with the statement: “Government investments in establishing technology platforms, technology transfer, and commercialization are higher in other countries than in the United States.”  He further stated that those making higher investments include China, Russia, and the European Union.

Multiple participants referred to the European Commission’s upcoming Horizon 2020 program, which will have major funding extending over 7 years. In addition to providing major funding for fundamental research, the Horizon 2020 website states that the program will help to:

“…bridge the gap between research and the market by, for example, helping innovative enterprises to develop their technological breakthroughs into viable products with real commercial potential. This market-driven approach will include creating partnerships with the private sector and Member States to bring together the resources needed.”

A key program within Horizon 2020 consists of the European Institute of Innovation and Technology (EIT), which as illustrated in the “Knowledge Triangle” shown figure 11, below, emphasizes the nexus of business, research, and higher education. The 2014-2020 budget for this portion of Horizon 2020 is 2.7 billion euros (or close to $3.7 billion in U.S. dollars as of January 2014).

As is often the case with technology and science, participants mentioned intellectual property (IP) (excerpted from pp. 43-44 PDF; pp. 37-8 print),

Several participants discussed threats to IP associated with global competition.43 One participant described persistent attempts by other countries (or by certain elements in other countries) to breach information  systems at his nanomanufacturing company. Another described an IP challenge pertaining to research at U.S. universities, as follows:

•due to a culture of openness, especially among students, ideas and research are “leaking out” of universities prior to the initial researchers having patented or fully pursued them;

•there are many foreign students at U.S. universities; and

•there is a current lack of awareness about “leakage” and of university policies or training to counter it.

Additionally, one of our earlier interviewees said that one country targeted. Specific research projects at U.S. universities—and then required its own citizen-students to apply for admission to each targeted U.S. university and seek work on the targeted project.

Taken together with other factors, this situation can result in an overall failure to protect IP and undermine U.S. research competitiveness. (Although a culture of openness and the presence of foreign students are  generally considered strengths of the U.S. system, in this context such factors could represent a challenge to capturing the full value of U.S. investments.)

I would have liked to have seen a more critical response to the discussion about IP issues given the well-documented concerns regarding IP and its depressing affect on competitiveness as per my June 28, 2012 posting titled: Billions lost to patent trolls; US White House asks for comments on intellectual property (IP) enforcement; and more on IP, my  Oct. 10, 2012 posting titled: UN’s International Telecommunications Union holds patent summit in Geneva on Oct. 10, 2012, and my Oct. 31, 2011 posting titled: Patents as weapons and obstacles, amongst many, many others here.

This is a very readable report and it answered a few questions for me about the state of nanomanufacturing.

ETA Feb. 10, 2014 at 2:45 pm PDT, The Economist magazine has a Feb. 7, 2014 online article about this new report from the US.

ETA April 2, 2014: There’s an April 1, 2014 posting about this report  on the Foresight Institute blog titled, US government report highlights flaws in US nanotechnology effort.

Report on nano EHS from US General Accountability Office (GAO)

According the June 22, 2012 news item on Nanowerk, The US General Accountability Office (GAO) has release a new report titled, Nanotechnology: Improved Performance Information Needed for Environmental, Health, and Safety Research (published May 2012). From the report,

Nanotechnology involves the ability to control matter at approximately 1 to 100 nanometers. Worldwide trends suggest that products that rely on nanotechnology will be a $3 trillion market by 2020. However, some of the EHS [Environmental, Health, and Safety]impacts of nanotechnology are unknown. The NSTC [National Science and Technology Council] coordinates and oversees the NNI [National Nanotechnology Initiative], an interagency program that, among other things, develops national strategy documents for federal efforts in nanotechnology.

In this context, GAO examined: (1) changes in federal funding for nanotechnology EHS research from fiscal years 2006 to 2010; (2) the nanomaterials that NNI member agencies’ EHS research focused on in fiscal year 2010; (3) the extent to which NNI member agencies collaborate with stakeholders on this research and related strategies; and (4) the extent to which NNI strategy documents address desirable characteristics of national strategies. GAO’s review included seven NNI agencies that funded 93 percent of the EHS research dollars in fiscal year 2010. This report is based on analysis of NNI and agency documents and responses to a questionnaire of nonfederal stakeholders.

GAO recommends that the Director of the Office of Science and Technology Policy (OSTP), which administers the NSTC, (1) coordinate development of performance information for NNI EHS research needs and publicly report this information; and (2) estimate the costs and resources necessary to meet the research needs. OSTP and the seven included agencies neither agreed nor disagreed with the recommendations. [p.2 of the PDF]

This provides some interesting contrast to the National Nanotechnology Initiative’s (NNI) 4th assessment report which I wrote about in my May 2, 2012 posting,

PCAST [President’s Council of Advisors on Science and Technology] acknowledges that the NSET [Nanoscale Science, Engineering, and Technology Subcommittee coordinates planning, budgeting, program implementation, and review of the NNI] has acted on our recommendation to identify a central coordina­tor for nanotechnology-related EHS research within NNCO. The EHS coordinator has done a laudable job developing and communicating the 2011 NNI EHS research strategy. [emphasis mine] However, there is still a lack of integration between nanotechnology-related EHS research funded through the NNI and the kind of information policy makers need to effectively manage potential risks from nanomaterials. The estab­lishment of the Emerging Technologies Interagency Policy Coordination Committee (ETIPC) through OSTP has begun to bridge that gap, but without close integration between ETIPC and the NEHI working group [Nanotechnology Environmental and Health Implications Working Group], the gap may not be sufficiently narrowed. OSTP and the NSET Subcommittee should expand the charter of the NEHI working group to enable the group to address cross-agency nanotechnology-related policy issues more broadly.

Alphabet soup, eh? The best I can gather is that the GAO report has identified gaps that are identified by the NNI (and which they have begun to address) as per my emphasis in the excerpt from the 4th assessment. As someone who does not know the politics or have access to inside information, the GAO report recommendations are much simpler to understand as the issues are laid out from a more ‘global’ perspective (or big picture perspective) as per US EHS nanotechnology research efforts. The NNI’s 4th assessment report offers more detail and, frankly, I found it more confusing.

This is my 2nd GAO report and, again, I love the writing and organization of the report. (Note: I am lauding the report writing skills.)  Thank you to Frank Rusco, Dan Haas, Krista Anderson, Nirmal Chaudhary, Elizabeth Curda, Lorraine Ettaro, Alison O’Neill, Tind Shepper Ryen, Jeanette Soares, Ruth Solomon, Hai Tran, and Jack Wang.

Regulating nanomaterials according to the US GAO and EPA

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

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

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

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

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

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

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

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

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

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

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

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

There’s more than one way to be exposed,

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

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

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

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

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

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

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

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

Compare,

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

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

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

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

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

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

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

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

US Government Accountability Office chimes in on the nanomaterials regulatory debate

Yet another jurisdiction (US) and government agency (Government Accountability Office [GAO]) has released a report about regulating nanomaterials. From the news item on Nanowerk,

The U.S. Government Accountability Office (GAO) has released a report “Nanotechnology: Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk” (pdf) in which it recommends that EPA complete its plans to modify its regulatory framework for nanomaterials as needed.

As usual, Canada is mentioned for its ‘nanomaterials inventory plan’ but for the first time it’s described as a plan and not a fait accompli,

Australia and the United Kingdom have undertaken a voluntary data collection approach whereas Canada plans to require companies to submit certain types of information.

Thank you to whoever authored the GAO report for getting it right. Meanwhile, I wonder when the Canadian government will choose to notify Canadians (or at least our companies) of this plan.

If you want an overview of the report do go to Nanowerk; I’ve started reading the report and will comment on it tomorrow.

One last note, I remember (having worked in a library and filed their documents) when GAO stood for Government Accounting Office.