Richard Denison, Ph.D., is a Senior Scientist.
It's been nearly a year since EPA launched its voluntary Nanoscale Materials Stewardship Program (NMSP) – and over three years since EPA was urged, by a diverse group of stakeholders, to do so only in conjunction with the development of mandatory reporting rules as a backstop and to limit the duration of the basic part of the program to at most six months.
EPA ignored that advice, and proceeded with an open-ended voluntary program and no development of backstop rules. Now EPA has issued its first evaluation of the NMSP. So what did EPA find?
Despite a major arm-twisting effort by EPA to get companies to sign up, only 29 have made submissions to EPA under the basic program, and only four have said they're willing to discuss the possibility of doing any testing under the in-depth program.
Perhaps not surprisingly, few of the submissions contain any health and environmental data – confirming that few if any nanomaterials have been sufficiently studied, despite their rapid commercialization. Also in the category of "not surprising:" Large amounts of the data that were submitted were claimed to be confidential business information – despite EPA's plea that companies disclose as much information as possible.
More surprising, but welcome, is EPA's forthright acknowledgment that the submissions cover only a small fraction of both: a) those nanomaterials likely to be already commercially available, and b) the underlying chemical structures on which they are based. EPA's report provides a rather extensive analysis that reveals the following:
- Fewer than 10% – 123 out of the more than 1,600 unique nanomaterials EPA estimates are already commercially available – were addressed in the basic program submissions.
- The submissions encompass only one-seventh (28 of 200) of the unique chemical structures on which nanomaterials in use or development are based.
[Update: In my haste to get this post up, while I got the "fewer than 10%" and "only one-seventh" right, I mis-stated the underlying numbers: The first bullet above should read "123 out of the more than 1,800 … ." And the ratio in the second bullet should be 34 out of 238 unique existing chemicals.]
EPA also acknowledged it cannot determine whether participants submitted information on all or only a subset of nanomaterials they produce, and whether information submitted for a given nanomaterial was complete or selective. EDF had predicted precisely this problem because of EPA's failure to include these metrics in the design of the Nanoscale Material Stewardship Program.
And given that only four companies have agreed to consider conducting any testing, EPA concluded that "most companies are not inclined to voluntarily test their nanoscale materials."
The good news is that, given the poor showing for the NMSP, EPA now says it is finally "considering how to best use testing and information gathering authorities under the Toxic Substances Control Act" to address the remaining gaps in information.
Reading between the lines a bit, this is the first time EPA has been willing publicly to state that mandatory reporting and testing rules will be needed to provide the Agency with the information it needs to craft a regulatory approach to nanomaterials.
Let's hope EPA is serious about refocusing its energies on these critical tasks.