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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.

In its press release, Environmental Defense Fund cites to limited participation and the fact that after six months of existence, "EPA has made virtually no information public about the limited number of submissions it has received. As a result, the public can have little confidence that the program is providing the information the Agency will need to protect citizens, consumers, workers and the environment from the potential risks of nanotechnology, according to Environmental Defense Fund (EDF)."  In addition, EDF is comparing the participation in the NMSP to the weak response received by the United Kingdom's DEFRA on its voluntary program.  We've posted on the DEFRA program before.  EDF also points to EPA's original prediction of 240 submissions from 150 companies for the basic program and 15 participants in the in-depth program.  While these numbers may not have been fully realized, let's look closely at the facts now that the basic program submission deadline has passed.

First, while the NMSP has been running for six months, the entirety of that time was spent on collection submissions from voluntary participants.  There was no indication from EPA that they would release information collected on a rolling basis or somehow provide their evaluation as submissions were received.  EPA has stated that it will take time to evaluate all of the submissions and release its thoughts after a period of review.  In fact, EPA stated on its NMSP website: "EPA will publish an interim report on the program in approximately a year from its launching on January 28, 2008. A more detailed report and program evaluation will be published after approximately two years. At the time of the two-year report, EPA intends to determine the future direction of both the basic reporting and in-depth data development phases, although adjustments or decisions on future steps may be made at an earlier point if sufficient experience is gained. This would also include consideration of use of regulatory authorities under TSCA." (emphasis added).  Consequently, EPA is taking time to consider all of the information and publish two overall reports, including an interim evaluation.

Second, let's look at the numbers.  EPA received submissions from 20 organizations (including some household names) covering approximately 90 nanoscale materials.  Further, another 10 organizations committed to the basic program, but have not yet submitted.  Beyond the fact that this is potentially a significant amount of technical data to sift through, this is not analogous to DEFRA's program where, to date, eleven submission (including two in the last quarter, the report for which was just released) have been received since September 2006.  Comparing EPA's response to DEFRA's is simply unfair.  Additionally, three companies have committed to the in-depth program and more can still be added.  While its clear EPA did not receive the level of participation it hoped for, there potentially (depending on what was submitted) very significant information in the hands of EPA, and that should not be discounted.

Declaring failure minutes after the deadline for submission passes is irresponsible and does nothing more than contribute to rumor and hearsay.  EPA received a significant response from the nanotechnology sector and it will take time for the agency to fully understand the information it now possesses.  With perhaps over 100 materials to evaluate, EPA's response cannot be instantaneous, and for it to do so would conflict with its reasoned position of wanting to understand the questions surrounding nanomaterials before making statements.  Good regulation does not come from snap judgments and unconsidered public statements.  EDF should give the agency time to understand what it has.  EDF has two choices, wait for the release of the report, or file a public records request for all of the publicly available information that was submitted.  But declaring failure through a press release does not help the agency or sector get closer to the answers being sought.  Oh, and if EDF submits the records request to EPA and received copies of the submission, I wonder if a black hole will appear at EDF if it doesn't like the answers.

While the full NMSP is slated to run for 2 full years, data submissions under the Basic Program are to be in by July 28.  This poses as bit of a problem in that the number of submissions and commitments remain low. Yes, a few months ago I said to give the program time, and I still believe that. However, with one time frame coming to an end, I'm becoming concerned at the lack of responses.

As of this posting, three companies have submitted Basic Program materials: DuPont, Office ZPI, and one confidential submission.  In addition 10 more commitments for submission under the program have been received: BASF Corporation, Bayer Material Science, Dow Chemical, Evonik/Degussa, General Electric, Nanocyl North America, Nanophase Technologies Corporation, PPG Industries, Sasol North America, and Strem Chemicals.

The concern, of course, if that if EPA does not receive enough voluntary information for it to use in educating itself on the risks posed by nanomaterials, it will make such submissions mandatory.  For my money, that's what is likely to happen.  There is still time to submit voluntary information, and still opportunities to do so confidentially.  The In-depth program will continue to run, but that portion seems to have been largely ignored.  Keep and eye on July 28--it'll come faster than you think.

The UK reports that no new submissions have been received by DEFRA since the last quarterly report in December 2007.  Consequently, the count for total submissions remains at nine; seven from industry and two from academia.  DEFRA is still seeking submissions under the VRS, but is recommending that the "objectives and data requirements for the scheme be more clearly articulated."  The stalling in the submission, albeit it light before, is not a good sign going forward for the program.

Additionally, and as we've previously discussed here, there is concern that the lackluster response associated with the VRS is a harbinger of what is to come under US EPA's NMSP.  And while the concern is legitimate, I still think its too soon to paint them all with the same brush.  Sitting here today, EPA has received three submissions under the Basic Program, with a commitment from ten other companies to submit.  All of this in just the last 4 months.  As they say in the investment world, past performance is no indication of future returns.  We'll have to continue being patient and let the system runs its course for the moment.

The radio show, which runs just under an hour and can be downloaded here, "Jim Willis, Director of the Environmental Protection Agency’s Chemical Control Division, discusses nanomaterials, the Toxic Substances Control Act (TSCA), and the Nanoscale Materials Stewardship Program."  Both of these issues are near and dear to the hearts of those of us here at the Nanotechnology Law Report.

Anyone looking to get a better feel for regulatory developments should listen in as Marlene Bourne and Director Willis discuss these issues and here what Director Willis has to say first hand.