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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.

DuPont released a statement that it was making this submission under the NMSP  in order to support EPA's program.  Said Terry Medley, global regulatory affairs director, "We are fully supportive of the [NMSP] and believe this program will give the EPA the information that it needs to help ensure the responsible use of new nanomaterials."  In the same statement, DuPont began encouraging other companies to make similar submissions to EPA.  Light Stabilizer 210 is a titanium dioxide compound used to protect plastics from sun exposure.  The same material was used as a test case under the Nano Risk Framework.

And, speaking of the Nano Risk Framework, DuPont's partner in that effort, Environmental Defense was very critical of EPA's NMSP, as recently as January 30--two days before DuPont submitted the first data set to EPA.  Environmental Defense claims the NMSP will only delay decision making by regulators while not providing necessary information.  Richard Denison, senior Environmental Defense scientist said, "EPA is simply 'kicking the can down the road' by shunning approaches that could have delivered needed information faster, and by opting instead to pursue an open-ended approach with no end in sight."  Environmental Defense is particularly critical of the lack of firm deadlines in the NMSP and the otherwise "loose design" of the program.

While the Nano Risk Framework is a voluntary system of "best practices" that does not involve any centralized reporting, I'm left to wonder what will become of the program now that one of the Framework's founders, DuPont, has signed onto the NMSP.  Certainly companies can participate in both without too much duplication of effort, but will they?  I'm similarly left wondering if there is any damage to the Environmental Defense/DuPont relationship that once seemed a promising partnership between the private and nonprofit sectors for responsible development of nanomaterials.  I hope that relationship is not negatively impacted by this apparent schism between the actors.

Finally, I am encouraged by the quick response of DuPont to support the NMSP.  I've been concerned that the NMSP will go the way of the similar program in the United Kingdom, that garnered 7 submissions in the last 16 months (see prior post here).  DuPont's immediate participation is an early sign of life for the NMSP.  We'll have to see if others follow suit.

Information for this post was obtained from SafeNano.

The partnership agreement outlines the relationship, and includes such areas as human health hazards, release and exposure potential, and occupational and environmental risk management.  The framework will primarily focus on the industrial, chemical, and manufacturing industries, and each partner will bear its own costs of research.  Further, the parties plan to involve additional stakeholders throughout the project in an effort to form a framework that will be widely accepted across all areas of nanotechnology.  Once the partnership is complete (following publication of the findings) all information will be released publicly for consideration.  A draft framework is available here, and is open for comment.

MEH:  This is exactly the type of partnership that will forward the research and understanding of nanotechnology impacts and how to address them.  By having two differing views involved, an understanding can be reached that can then be spread to the industry at-large.  The more stakeholders that get involved in the process, the better the resulting research and regulations will be.  This partnership is an excellent first step, and both DuPont and Environmental Defense should be commended for their initiative.