Environmental Defense and NMSP
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.
Michael Heintz takes issue with EDF's news release lamenting the mediocre level of participation and lack of transparency surrounding the EPA's Nanoscale Materials Stewardship program. His basic argument is that we should have more patience and let the program 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 program plan 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 has bumped up a bit. 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 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.
And while EPA notes that the submissions "cover more than 90 nanoscale materials," information on 63 of those materials came from 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 some of us don't think that launching, after years of delay, a years-long process to collect whatever selective information a selective group of companies 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?