Tag Archives: 21st Century Challenges: Reexamining the Base of the Federal Government

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.