Interim Report: Lukewarm Response to EPA's Nanoscale Material Stewardship Program

Posted on January 13, 2009 by John C. Monica, Jr.

Earlier today, the EPA published an interim status report regarding its Nanoscale Materials Stewardship Program.  A final report is expected in early 2010.

Nanoscale Materials Stewardship Program, Interim Report, January 2009, U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics.

At the outset, EPA notes that "[t]he findings and conclusions [of the] report should not be construed or interpreted to represent any Agency regulatory or statutory guidance or statement of official Agency policy."   Several companies submitting NMSP data should be relieved by this disclaimer, as EPA identified 18 nanoscale materials in NMSP submissions which may be considered new chemical substances under TSCA and subject to premanufacturing notice requirements.  Whether EPA takes any enforcement steps in this regard remains to be seen.

Getting to the highlights of the report, EPA concludes that the NMSP has (thus far) produce mixed results:

  • "In the aggregate, the NMSP has sufficiently advanced EPA’s knowledge and understanding to enable the Agency to take further steps towards evaluating and, where appropriate, mitigating potential risks to health and the environment."
  • "It appears that nearly two-thirds of the chemical substances from which commercially available nanoscale materials are based were not reported under the Basic Program."
  • "It appears that approximately 90% of the different nanoscale materials that are likely to be commercially available were not reported under the Basic Program."
  • "The low rate of engagement in the In-Depth Program suggests that most companies are not inclined to voluntarily test their nanoscale materials."

EPA's overall conclusion is that:

"[T]he NMSP can be considered successful. However, a number of the environmental health and safety data gaps the Agency hoped to fill through the NMSP still exist. EPA is considering how to best use testing and information gathering authorities under the [TSCA] to help address those gaps."

My own view is that response to the NMSP has been lukewarm, at best.

Analysis of Current Submissions

As of December 8, 2008 information under the Basic Program has been submitted by 29 companies/associations, covering 123 nanoscale materials.  Seven additional companies have also committed to submitting data under the Basic Program at a future date.  The In-Depth Program has commitments from four companies thus far.   Additionally, the American Chemistry Council (ACC) has expressed an interest in coordinating In-Depth data submissions. 

A chart from the interim report breaking down Basic Program submissions by material type follows.  Nanoscale metals and metal oxides predominate.  Many materials are still in the research and development stage.

  

Beyond numbers and types of nanoscale materials, EPA also notes that "very few submissions provided either toxicity or fate studies."  This lack of information provides EPA with several challenges to meeting the NMSP's basic goal of determining whether certain nanoscale materials or categories may present risks to human health and the environment.  No doubt these challenges have contributed to EPA's recent attempt to use TSCA consent orders and SNURs to generate animal inhalation toxicity data.

An Ill-Fated Comparison

As apparent justification for the number and quality of submissions, EPA compares the information it has received under the NMSP thus far with the information available in two publicly available databases:  (i) Nanowerk's Nanomaterials Database; and (ii) Project on Emerging Nanotechnologies Inventory of Nanomaterials in Consumer Products.  EPA selected these two databases because "[a]s far as EPA is aware, there is no comprehensive database of nanoscale materials, which is a critical need for better understanding the universe of commercially available nanoscale materials."  Unfortunately, neither database was designed for this purpose (although I am a big fan of both).  Using these databases in this manner further points out the difficulties facing EPA.  Simply put, both Nanowerk and PEN appear to have far better data collections than EPA -- an unacceptable condition.

Nonetheless, EPA's search of the Nanowerk database identified 2,084 potential nanoscale materials, which the Agency then condensed to a list of 1332 potential submissions by excluding new chemical substances under TSCA (e.g./ carbon nanotubes and fullerenes), eliminating materials in which it has no interest, and grouping materials with the same molecular identity.  EPA then identified 55 commercially relevant chemicals from this truncated list.  EPA, however provides, no good reason for excluding new chemical substances from its analysis, nor does it make a convincing case that it can actually determine molecular identity from Nanowerk's database.

A similar analysis of PEN's database identifies 566 nanoscale materials, out of which EPA finds that 48 are commercially relevant chemicals. 

It is clear that despite all of this winnowing, the amount and quality of data submitted thus far under the NMSP is dwarfed by that available in both the Nanowerk and PEN databases.  Given this situation, it is hard to imagine that advocacy groups will remain muted until EPA's final NMSP report is released in 2010.  Another table from the report summarizing this comparison data follows.

 

 



 
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Spanning the Data Gap: A Marathon or Sprint?

Posted on June 11, 2008 by Michael E. Heintz
Another interesting read from our friends at Nanowerk (these "spotlight" features are very good and will really get your brain going).  This time around the topic addresses the nanotechnology data gap and the role peer-reviewed journals play.

Author Michael Berger points out the problems with the length of time in publishing the results of scientific studies in relation to the freshness of the data.  Without repeating his well written piece, there are some particularly interesting points, such as:

  • A peer-reviewed paper takes almost 2 years to publish once the scientific research is completed;
  • In a fast-growing field like nanotechnology, the knowledge contained within the field doubles roughly every five years (however, he does not define what "knowledge" means in this context)

He's got some other good points and examples, but I don't want to spoil the ending for you.

This raises the fairly obvious problem that the published results of research may very well be outdated and stale by the time the research paper is in circulation.  It is an interesting read, and one I recommend (and it'll only take about 10 minutes). 

Clearly, the delay from research to publication is a problem.  As we've talked about here before, the "data gap" that exists is one of, if not the, major barrier to nanotechnology regulation and addressing the health and safety issues that are at the front of everyone's mind.  But how to get the fast-paced information out faster?  One of Mr. Berger's suggestions is a wiki, which we've talked about before and which ICON is proposing be used for "good practices" development.  Maybe this format will work for peer-reviewed research as well (if any researchers out there are reading this, I'd be curious to know your thoughts).

Regardless, Mr. Berger and Nanowerk are correct: something has got to give between the slow pace of publication and the fast pace of the sector.  What good is information that's two years old and new information has been revealed in the interim?  Is there room to improve the system, or is the process of peer-reviewing the best we have?  Something to think on for a while.
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Unraveling Nanotechnology Standards

Posted on May 19, 2008 by Michael E. Heintz
One of my "go to" nano news sources, Nanowerk, posted an interesting story last week concerning the competing standards that are emerging with regards to the technical side of nanotechnology.  The article outlines the various scientific standards that are developing, and the lack of any one overarching, or governing, standard.

The author, Michael Berger, lists the following five problems with regards to a lack of consistent nanotechnology standardization:

  • "no internationally agreed terminology/definitions for nanotechnology
  • no internationally agreed protocols for toxicity testing of nanoparticles
  • no standardized protocols for evaluating environmental impact of nanoparticles
  • no standardized measurement techniques and instruments
  • no standardized calibration procedures and certified references materials"

In addition, there are no fewer than seven organizations with competing nanotechnology standards statements, including ASTM, ANSI, IEEE, and ISO--all well respected organizations.  In addition, the nanotechnology standards debate has been going since at least December of 2003.

Well, this got me to thinking.  In an instance of life imitating life, the competing technical standards for nanotechnology closely resembles the diverging regulatory standards that are developing (oh, c'mon, you knew where I was going with this didn't you?).

For example, take a look at the three state statutes concerning the definition of "nanotechnology."  Each of Michigan, Arkansas, and Oklahoma have enacted binding, statewide laws concerning what defines nanotechnology:

  • Arkansas, A.C.A. §15-4-2103(5): “Materials and systems whose structures and components exhibit novel and significantly improved physical, chemical, and biological properties, phenomena, and processes due to their nanoscale size;"
  • Oklahoma, 74 Okl St. Ann. §5060.4(12): “‘Technology developed at the molecular range (1 nm to 100 nm) to create and use structures, devices, and systems that have novel properties because of their small size;"
  • Michigan, M.C.L.A. 206.30 -125.2088a: “Materials, devices, or systems at the atomic, molecular, or macromolecular level with a scale measured in nanometers;"

Now, take a look at the bold sections.  All three of these statements concerning the size of nanotechnology have slightly different meanings.  In fact, only one, Oklahoma, actually defines nanotechnology as existing between 1-100 nanometers.  While this may not seem to be an overly important consideration now, imagine what these further regulations in these states will look like with diverging bases.  Add to these emerging state statutes the previously discussed Berkeley standards, and the forthcoming Cambridge standards, and a very murky picture begins to develop indeed. 

While I am not suggesting that there should be one, all-inclusive set of regulatory standards for nanotechnology, I am suggesting that we need to be mindful of these diverging paths and strive to reduce uncertainty and confusion by the regulated community as these standards develop.  Just like consistent technical standards will provide certainty to the scientific community, developing regulatory standards with an eye towards consistency will provide certainty for the regulated community.
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