Tired of Waiting … [with apologies to Ray Davies]

Richard Denison, Ph.D., is a Senior Scientist.

EDF's recent news release that gave a less-than-glowing review to the performance of EPA's Nanoscale Materials Stewardship Program (NMSP) engendered a critique from Michael Heintz of Porter & Wright, accusing us of being "irresponsible" and potentially "sector damaging." Our release had lamented the mediocre level of participation and lack of transparency surrounding the NMSP. I've posted a reply to Michael's post, but also want to post it here.

Michael's basic argument is that we should have more patience and let the NMSP play out over the next two years before saying anything. Those of us following the issue over the past several years know that we've all been waiting a long time already, even as hundreds of nano products have hit the shelves.

EPA dallied nearly 2.5 years after accepting, in November 2005, its own federal advisory committee's recommendation to launch a voluntary program. Also going against that advice, EPA made the program open-ended, while the committee had recommended a limited duration on the order of six months. And — despite being urged to do so by us and other commenters on the draft program plan circulated last year — EPA failed to provide any meaningful metrics by which to measure whether the NMSP is yielding sufficient information or not.

Finally, while EPA is still paying lip service to the possibility of some day developing mandatory reporting rules if enough companies don't volunteer, its advisory committee recommended in 2005 that such rules be developed in parallel with the NMSP — a step EPA appears not even to have begun.

Since our news release, participation in the NMSP has bumped up a bit.  As of August 5, EPA had received basic program submissions from 20 companies, with an additional 10 pledging to make such submissions and three indicating interest in the in-depth program.

Moreover, almost certainly in direct response to our criticism, EPA has now actually posted the submissions it received from seven of the 20 companies — while indicating it can't post those from the 13 other companies because the submitters claimed their documents to be confidential business information (CBI). That's a welcome if small step toward the greater transparency we've called for. Why should we have to wait, as Michael argues, until EPA issues its interim evaluation to get access to non-CBI submissions EPA has already received?

I've had a look at those submissions EPA has posted, by the way, and urge Michael and all of you to do so. Despite EPA's statement that they are the "non-confidential submissions," in fact a very large fraction of the information they contain is marked as CBI. Here is a not-atypical page from one of those submissions (click to enlarge):



And while EPA notes that the submissions "cover more than 90 nanoscale materials," information on 63 of those materials came from one company, and 81 materials are covered by the seven companies with posted submissions. Hence, as we suspected, most companies have submitted information on only a single nanomaterial.

Finally, with few exceptions, the extent of information provided is exceedingly limited even where it is not claimed CBI: For most materials, only cursory information on the material identity and physical-chemical properties is all that is provided. Health and environmental effects information has been provided for at most half a dozen of the materials, and some companies have claimed even that information to be CBI, despite the fact that TSCA prohibits health and environmental studies from being eligible for CBI status.

Call me impatient, but I don't think that launching, after years of delay, a years-long process to collect whatever selective information a selective group of companies already possesses and chooses to provide to EPA is a sufficiently vigorous response to the legitimate public expectation that EPA (and other federal agencies) should be taking effective action to identify, understand and address the possible risks of nanotechnology.

Collecting existing information was only supposed to be step one in EPA's determination of an appropriate regulatory response. How long would Michael have us wait for that?

This entry was posted in Health Policy, Nanotechnology, Regulation and tagged . Bookmark the permalink. Both comments and trackbacks are currently closed.