President's Council Evaluates National Nanotechnology Initiative

Posted on March 19, 2010 by John C. Monica, Jr.

This article originally appeared on the National Nanomanufacturing Network's InterNano website earlier today. It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

Maxine Savitz[1] and Ed Penhoe[2] provided a recent presentation summarizing the highlights of the President’s Council of Advisors on Science and Technology (PCAST)[3] report on the status of the US National Nanotechnology Initiative (NNI) at a public meeting held at the National Academics on March 12, 2010.

Ms. Savitz provided a brief review at the beginning of the presentation regarding how, when, and why NNI was formed; its history from 2000 - 2010; and some of the participants in the PCAST review process. Participants included representatives from DuPont, IBM, A123 Systems, Nanocomp Technologies, Rice, Harvard, Caltech, Sandia National Labs, and the Woodrow Wilson Institute. Ms Savitz also explained that the group held two prior working meetings to solicit input from government agencies, the legislative and executive branches, as well as outside stakeholders. Finally, she explained that PCAST’s report has three major thematic areas: NNI program management; NNI output and work product; and NNI environmental, health, and safety programs and strategies.

Ed Penhoet then provided an update regarding NNI’s continued successes. He noted that the US is currently the world leader in nanotechnology and commercialization, but that other nations are gaining fast -- particularly in Asia and Europe. He further noted that NNI has had a substantial impact on the US nanotechnology industry over the past ten years, which can be seen in the larger number of nanotechnology patents filed, nano-related publications, and nano-related products hitting the commercial market during that period.

Mr. Penhoet further explained that while NNI is being effectively managed, there is still room for some improvement and greater coordination.

For an example, Mr. Penhoet pointed out that there is a lack of basic underlying data from which to analyze the economics of nano-related research, development, and commercialization in the US. Thus, it is difficult to precisely quantify the economic effectiveness of the NNI in measurable terms.

As another example, Mr. Penhoet also mentioned the need to identify and understand potential nano-related risks -- both for purposes of fundamental science, and also to provide a clear regulatory environment and path for commercialization. While undoubtedly a significant portion of PCAST’s written report touches on these issues, the topic was only briefly mentioned in passing during the presentation.

Mr. Penhoet then spent the majority of his presentation explaining the five major recommendations embodied in PCAST’s written report:

  • Increase NNI funding for manufacturing research while maintaining support for basic research.
  • Strengthen the NNCO, the NNI coordinating entity, with additional funds and a broader mandate.
  • Require that metrics be developed to track benefits of nanotechnology such as job creation.
  • Develop a cross agency strategy that links EHS research and knowledge gaps and decision making needs.
  • Expedite the citizenship review process for those receiving advanced degrees in science and engineering.

The presentation closed with comments by several PCAST members regarding (i) potential methods for developing the underlying economic data needed to properly evaluate nano-related job creation and return on investment; and (ii) potential methods for increasing retention rates of foreign students obtaining advanced nano-related degrees in the US by reducing and/or streamlining citizenship restrictions.

PCAST voted to accept and approve the report after it is amended to reflect the comments discussed during the presentation.

 

References
[1] Director of the Washington Advisory Group, an LECG Company. Ms. Savitz is the former Deputy Assistant Secretary for Conservation, US Department of Energy. Prior to her DOE service, she was program manager for Research Applied to National Needs at the National Science Foundation. Following her government service, she served in executive positions in the private sector, including: President of Lighting Research Institute, assistant to the vice president for engineering at The Garrett Corporation, and General Manager of Allied Signal Ceramic Components. She recently retired from the position of General Manager for Technology Partnerships at Honeywell.

[2]President of the Gordon and Betty Moore Foundation. Mr. Penhoet is the former dean of the School of Public Health at the University of California, Berkeley, prior to which he cofounded and managed the Chiron Corporation. Prior that he was a faculty member of the Biochemistry Department of U.C. Berkeley. Mr. Penhot currently serves as the vice chairman of the Independent Citizen’s Oversight Committee which oversees the California Institute for Regenerative Medicine created by the passage of Proposition 71, the stem cell initiative.

[3] http://www.whitehouse.gov/administration/eop/ostp/pcast.

 

Tags: , , , , , , , , , , , , , , ,

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.

 

 



 
Tags: , , , , , , , , , , , , , , , ,

EPA Issues Significant New Use Rules for Two Nanomaterials

Posted on November 19, 2008 by John C. Monica, Jr.

This article, which appeared in the Nov. 17, 2008 issue of Pesticide & Toxic Chemical News, Volume 37, No. 3, was reproduced with permission from Agra Informa. Further use of this article is prohibited without the express written permission of the publisher. For more information about Pesticide & Toxic Chemical News, Food Chemical News or other Agra Informa publications, go to: www.foodregulation.com .

EPA earlier this month announced it is promulgating significant new use rules (SNURs) under TSCA for two nanomaterials — siloxane modified silica nanoparticles and siloxane modified alumina nanoparticles — that were subject to premanufacture notices (PMNs). Some stakeholders view the move as a further sign that EPA is willing to use its authority to regulate nanomaterials, although to what extent remains uncertain.

The rules take effect on Jan. 5, 2009 unless the agency receives critical comments before Dec. 5.
The SNURs are the latest action from EPA on the nanotechnology front. The agency recently issued a consent order for carbon nanotubes (see PTCN, Oct. 20, Page 1). In addition, EPA provided clarification of TSCA requirements for carbon nanotubes last month (see PTCN, Nov. 3, Page 23).

Fewer than 10 SNURs for nanomaterials have been promulgated, according to EPA spokesperson Enesta Jones, but she could not name the materials or when the SNURs had been promulgated because of confidential business information protections.

With the most recent SNURs, anyone who intends to manufacture, import or process either siloxane modified silica nanoparticles or siloxane modified alumina nanoparticles for a significant new use, which includes using either substance without gloves or a respirator and using either substance as a powder, is required to notify EPA at least 90 days before beginning to do so. "The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs," the agency said in a Nov. 5 Federal Register notice.

According to their PMNs, siloxane modified silica nanoparticles and siloxane modified alumina nanoparticles will be used as additives. Based on data from tests of unidentified analogous material and the substances' physical properties, EPA has determined that there are concerns for lung effects from inhalation and systemic effects from dermal exposure. However, the PMNs indicate worker inhalation exposure to the alumina nanoparticles is expected to be minimal, inhalation exposure to the silica nanoparticles is not expected, and dermal exposure to both materials is also not expected.

"Therefore, EPA has not determined that the proposed manufacture, processing, or use of the substance[s] may present an unreasonable risk," the agency said in the FR notice. "EPA has determined, however, that use without impervious gloves or a NIOSH-approved respirator with an [Assigned Protection Factor] of at least 10; the manufacture, process, or use of the substance[s] as a powder; or uses of the substance[s] other than as described in the PMN[s] may cause serious health effects."

EPA would have to be notified at least 90 days before anyone began to manufacture, process or use the nanomaterials in such ways.

The agency has also determined that the results of a 90-day inhalation toxicity test would help characterize the human health effects of the two nanomaterials, although the test isn't required.
"Manufacture can occur as long as the manufacturer does not engage in the significant new uses," Jones told Pesticide & Toxic Chemical News via e-mail.

"[The 90-day inhalation toxicity test] is the test EPA recommends to be conducted to address health concerns cited in the SNUR. In other words, if a manufacturer wants to engage in the new uses or have EPA modify or revoke the SNUR, then conducting these tests could help EPA change its original findings."

The 90-day inhalation study is the same study that is required under the recently issued carbon nanotube consent order. But the study is not designed for determining chronic effects or for nanomaterials, according to John Monica, head of the nanotechnology practice group at the law firm of Porter Wright Morris & Arthur.

Monica told PTCN that EPA can recommend alterations to a study to make it more relevant for a specific material, and in fact did so for the inhalation studies requested in some of the other non-nanomaterial SNURs also announced in the Nov. 5 FR notice.

The SNURs and consent order are a "great opportunity" to get testing done on nanomaterials, but EPA needs to sit a group of experts down to determine how chemical test guidelines need to be modified for nanomaterials, Monica said. "During the request for comments [on the SNURs], someone will raise or should raise the issue."

Monica added he would expect someone to ask EPA to identify the analagous materials and test data it used to determine there are concerns for certain effects.

The SNURs, consent order, and carbon nanotube notice indicate what EPA has maintained all along — that EPA has the authority to regulate nanomaterials under TSCA and is willing to use it, Monica said.

Betsy Mason, an associate in the law firm Goodwin Procter's Environmental and Energy Practices, echoed Monica, telling PTCN that EPA's recent actions show "the agency is willing — perhaps more now than previously — to use the different legal tools available to it under TSCA Section 5 to regulate nanomaterials."

But Mason also noted that it isn't yet clear whether the agency is shifting away from relying on voluntary industry efforts like the Nanoscale Materials Stewardship Program to "bona fide regulation and enforcement" or if it's using the SNURs and consent order as a supplement to encourage more volunteers to participate in such initiatives.

"In either case, I think it's reasonable to expect that EPA will issue more nano-related consent orders and more nano-related SNURs in the future," she said.

U.K. commission urges testing

While EPA is starting to use some of its regulatory powers to address the potential risks of nanomaterials, the United Kingdom's Royal Commission on Environmental Pollution is urging quick action on testing and regulating nanomaterials in a report published Nov. 12.

The commission, which is appointed by the Queen and funded by the government, publishes in-depth reports on critical environmental issues. In its current report, "Novel Materials in the Environment: The Case of Nanotechnology," the commission finds no evidence of harm to human health or the environment from nanomaterials.

"However, it is very early in the development of this technology, and the amount of testing has been relatively limited," the commission said in a statement. "We are aware that laboratory tests on some nanomaterials suggest that they have properties which could cause concern. This strengthens our case for an increase in the amount and type of testing to assess whether these theoretical risks are real, and to monitor their behavior in the environment."

Furthermore, this research has to be done "on a more systematic and strategic" basis, which includes evaluating methods for predicting the fate and effects of nanomaterials, better understanding of the principles that determine nanomaterial toxicity, and enhancing nanomaterial monitoring and surveillance methods, the commission says in its report.

As for the U.K. government, the commission recommends that any revisions to existing regulations should be focused on the properties of nanomaterials, not their size. "Since these properties and functionalities will often differ substantially from those of the bulk material, strict chemical equivalence does not preclude the need for a separate risk assessment," the report says. Furthermore, the government should prioritize testing, starting with those materials with properties suggesting they pose a risk to human health or the environment. The government should also require companies to report any "reasonable suspicion" that a nanomaterial poses a risk "at the earliest opportunity."

The commission's report is available at www.rcep.org.uk/novelmaterials.htm.

— Liz Buckley elizabeth.buckley@informa.com

 
Tags: , , , , , , , , , , , , , , , , , , , ,

Reducing NanoRisks and Increasing NanoRevenues

Posted on June 26, 2008 by John C. Monica, Jr.

The Woodrow Wilson International Center for Scholars' Project on Emerging Nanotechnologies (PEN) recently published a short pamphlet intended to steer "nano firms" down the path towards commercial prosperity.

D. Lekas, "How to Reduce Your Firm's Risk and Increase Revenues Related to Nanotechnology," Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars, PEN Brief No. 4, April 2008.

PEN's "8 Step Program for Small Firms" is:  1. focus on the bottom line; 2. become or develop a champion within your firm; 3. incorporate life cycle thinking and operations and product development; 4. seek information and assistance on EHS implementation; 5. follow best practices for worker health and safety precautions; 6. prepare for potential nano-specific regulations; 7. increase educational efforts; and 8. seek continued improvement.

The new pamphlet is somewhat superficial and lacks the detail provided in PEN's numerous regulatory papers.  Additionally, regular readers will note that steps 3-6 in particular have been advocated by PEN in one form or another since its inception.  However, two of our friends received nice plugs under step 6 where PEN suggests that "[t]o keep up with the latest developments, firms may wish to subscribe to various listservs, including . . . www.nanoregnews.com . . . [and] . . . www.smalltimes.com."

Tags: , , , , , , , , , , , ,