Richard Denison, Ph.D., is a Senior Scientist.
A growing number of observers of nanotechnology policy in the U.S. – at least those outside the U.S. government! – recognize that the Toxic Substances Control Act (TSCA) is poorly suited both to spur the generation of sufficient information about nanomaterials, and to ensure that information indicating potential risks will trigger meaningful action. So why not just tweak TSCA to make it work better for nano?
In earlier posts, I have explored in some detail the challenges that arise in trying to apply TSCA to nanomaterials. Others have done so as well: the Environmental Law Institute, NRDC, the Project on Emerging Nanotechnologies, and the American Bar Association, to name a few.
On July 23, former EPA official Terry Davies released an excellent report prepared for the Project on Emerging Nanotechnologies, titled Nanotech: A Regulatory Blueprint for the Next Administration. In it, he usefully proposes a number of surgical strikes to fix key provisions of TSCA (see his Appendix C).
What is notable about these fixes is that all but one would affect and apply to all chemicals under TSCA, not just nanomaterials. That leads me to ask: Do we need a nano-fix to TSCA – or do we simply need to fix TSCA? I will argue here that the latter approach is where we need to start, for two main reasons.
We should avoid inadvertently setting a double standard
First, fixing TSCA for all chemicals avoids setting up a double standard, whereby nanomaterials would be subjected to greater scrutiny merely because they're nanomaterials, which amounts to an implicit assumption that, a priori, they're more dangerous or less well-studied than conventional chemicals.
One example: I've always been bothered by the call from some groups to selectively require the labeling of products containing nanomaterials. I share their motivation – to flag the fact that a product contains ingredients that have not been tested sufficiently or shown to be safe. But using those criteria, many if not most product ingredients warrant labeling! (I personally support the growing calls for companies to disclose the identity of all of the ingredients in their products, nano or not.)
Fixing TSCA for all chemicals will give us most of what we need for nanomaterials
The second reason I think we need to focus on a broad fix to TSCA is that making TSCA "safe" for all chemicals will get us 90% of the way to where we need to go to ensure the safety of nanomaterials. How would an improved U.S. chemicals policy – in and of itself – help with nanomaterials?
Consider the European Union's sweeping new REACH Regulation, which was developed without nanomaterials in mind at all. I absolutely agree there is a need to further tailor REACH to ensure it is adequate for nanomaterials, as most recently called for by the European Trade Union Confederation (ETUC) and the subject of a current European Commission consultation. But – even if REACH were left untouched – it will cover nanomaterials far better than TSCA ever could. Here are a few reasons:
First, EU officials are taking the same position that I blasted EPA for taking: maintaining that nano forms of substances already in commerce are existing, not new, substances. Yet I am far less concerned about such a decision in the context of REACH. That's because REACH, unlike TSCA, largely eliminates the distinction between new and existing chemicals – it requires that both types of chemicals be registered, tested, their uses identified and assessed. None of that will happen for nanomaterials deemed existing substances under TSCA, so EPA's decision has far more dire implications.
Second, REACH obligates a company to update its registration, datasets and assessments whenever the composition, use or knowledge of the risks of a chemical change – changes that would very likely be triggered by introduction of a new nano form of an existing chemical. This provision is essentially an automatic Significant New Use Rule (SNUR), in EPA jargon – except that it applies to all chemicals all of the time. In contrast, under TSCA, EPA would have to first determine that the nano form of a chemical represents a truly "new" use. If not, EPA could not issue a SNUR because, by definition, the use would not be "new"! Then EPA would have to go through a full notice-and-comment rulemaking process. Even then, only notification would be required, not development of new data or a robust assessment.
Finally, the threshold triggering registration requirements under REACH is set at one metric ton (2,200 pounds) of production or import per company per year. That threshold is far lower than the various exemption and threshold levels that apply under TSCA (discussed in parts 2, 3 and 4 of my earlier series of posts). These range from:
- 22,000 pounds per year to qualify for a low-volume exemption from new chemical notification requirements, to
- 25,000 pounds per year for TSCA Inventory Update Reporting, to
- 100,000 pounds per year that defines an exempted "small manufacturer," to
- a whopping 1,000,000 pounds per year, which is the "substantial production" threshold that is but one of several conditions that must be met for a chemical to be subject to mandatory testing.
I share the concerns of ETUC and others that some nanomaterials will be missed by the one-metric ton threshold for REACH registration, and that data requirements for low-volume substances under REACH are insufficient for nanomaterials. But even before REACH is more appropriately fitted to nanomaterials (something the EU appears intent to do), it is a vast improvement over the status quo in the U.S.
Bottom line: We need to reform TSCA for all chemicals, keeping nanomaterials squarely in mind as we do so. A good start: The Kid-Safe Chemicals Act of 2008, identical versions of which were introduced in May in both the U.S. House of Representatives by Representatives Solis and Waxman (H.R. 6100) and in the U.S. Senate by Senators Lautenberg, Boxer, Clinton, Kerry, Menendez and Whitehouse (S. 3040).