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