Richard Denison, Ph.D., is a Senior Scientist.
Since my first post concerning EPA's Consent Order, I've been reflecting further on the management conditions it imposes – or, more accurately, on what conditions it doesn't impose. The Order's only such conditions address potential worker exposure. What about the rest of the nanomaterial's lifecycle?
The need to consider the full lifecycle and the full range of potential release and exposure pathways is a basic tenet of sound and responsible management of nanotechnology. That's the backbone of the EDF-DuPont Nano Risk Framework, and it's also a key principle in EPA's own Nanotechnology White Paper and Nanotechnology Research Strategy.
Yet the Consent Order lacks conditions to address any potential releases or exposures beyond requiring gloves and other personal protective equipment for workers handling the nanomaterial.
Remember, the Consent Order notes that no test data were included in the producer's premanufacture notification (PMN). On what basis, then, has EPA concluded that no other potential risks exist? What about potential releases:
- from the manufacturing facility to the ambient air or water?
- from disposal or other management of wastes?
- from downstream transport, storage or processing?
- from post-use management (e.g., aging, weathering, repair, recycling) and disposal of products (electronics, polymer composites) containing the nanomaterial?
Nothing in the Consent Order addresses these questions – not, for example, a requirement to test products for potential releases, not even provisions to require reporting of waste management information or measurement or monitoring of releases.
Now, it may be that EPA has somehow managed to fully evaluate these and related questions and has determined that all of these risks are – and will remain, no matter what quantity of the nanomaterial is produced and used in the future – negligible. If so, it should disclose how and on what basis it did so.
EPA's failure to make public the decision framework it uses to evaluate new chemical submissions for nanomaterials – something we and other stakeholders have been requesting for some time – is a major impediment to building public trust in its process.
EPA's only bite at the apple
Some might argue that all this is premature and that EPA should wait until manufacture and use of this nanomaterial has ramped up even to consider such questions. But here's the problem with that: Under TSCA, the PMN review and conditions imposed through the Consent Order are essentially EPA's only bite at the apple.
Once Swan Chemical commences manufacture of its multiwalled carbon nanotubes (MWCNTs), they will be listed on the TSCA Inventory and will no longer be a "new" chemical. At that point, anyone may manufacture and use the substance without even having to notify EPA. And no matter what the quantity of the nanomaterial being produced and used, no further review by EPA would be triggered.
It should be noted that EPA is likely developing a Significant New Use Rule (SNUR) to accompany this Consent Order, and there are hints of that in the Order itself. But all that a SNUR will do is to extend the same conditions that apply to the submitter of the PMN to other producers; it would require them to notify EPA only if they don't comply with these conditions.
Should a concern later develop about some other type of release or exposure not addressed by the Order and SNUR, EPA's only recourse would be to seek to use its authority under TSCA Section 6 to regulate the MWCNTs as an "existing" chemical – something EPA was unable to do, ironically, even for asbestos. Yet that would be the only way that EPA could impose further conditions on production, processing, use, distribution or disposal of this nanomaterial.
Absent reform of TSCA to provide EPA with greater authority to regulate "existing" chemicals, EPA's new chemical review is, practically speaking, the only chance to ensure that potential risks across a new substance's full lifecycle are addressed. An examination of EPA's Consent Order suggests that this opportunity has been lost for this nanomaterial.