Richard Denison, Ph.D., is a Senior Scientist.

[Links to posts in this series: Part 1, Part 2, Part 3, Part 4, Part 5]

In this and my next two posts, I want to explore the question of whether EPA has sufficient authority under the Toxic Substances Control Act (TSCA) to effectively oversee nanotechnology.  EPA (as well as the White House) maintains that the agency has ample statutory authority to do what’s needed to identify and address any potential risks nanomaterials may pose to consumers, the general public and the environment.  I beg to differ. 

As others have noted, there is no question that TSCA “covers” nanomaterials, that is, a nanomaterial meet the law’s definition of a “chemical substance” and hence fall within TSCA’s domain – assuming, that is, that it is not used as a pesticide, drug, food or food additive, or cosmetic or personal care ingredient, in which case it does not (and instead is covered by another law).

But the real question is whether, in practice, EPA has the ability to apply and tailor TSCA’s provisions to address the special challenges posed by nanomaterials, as distinct from other chemical substances.
 
First let’s set the stage.  In this post, I’ll briefly discuss a recent decision EPA made that greatly limits its own authority over nanomaterials.  In my next post, I’ll discuss some of the major constraints on EPA’s authority for nanomaterials deemed to be “new chemicals” under TSCA.  In a third post in this series, I’ll do the same for those nanomaterials that EPA considers “existing chemicals.”

This distinction between “new” and “existing” chemical status under TSCA is critical.  (But, as I’ll discuss in my next post, even a “new chemical” designation for a nanomaterial is far from nirvana in terms of EPA’s ability to discern and mitigate potential nano risks.)

You are to be forgiven for thinking this “new vs. existing” question is a no-brainer.  Of course, you say, nanomaterials are new!  After all, that’s what all the buzz is about, right?  Would the Feds be spending $1.5 billion annually to develop and promote nano if it wasn’t new?  Not so fast, I’m afraid.

EPA recently ruled that TSCA precludes it from considering anything other than a material’s chemical structure to decide whether or not it is a new chemical substance.  As a result, it has decided to designate any and all nano forms of chemicals whose chemical structure is already on the TSCA Inventory to be “existing” rather than “new” substances.  To EPA, size really doesn’t matter – nor does surface chemistry or reactivity or any other property that makes a nanomaterial a nanomaterial. 

Of course, EPA’s policy decision flies in the face of nano science, which makes clear that a nanomaterial’s properties are dictated at least as much by its physical characteristics as by its chemical structure.

But it gets worse:  EPA’s ruling effectively guts the only meaningful opportunity EPA – and hence the public – had to ensure that such nanomaterials get any scrutiny before they hit the market.  That’s because EPA has authority to do a pre-market review only for new chemicals.  (As we’ll see in my third post, EPA’s options under TSCA to control a chemical already on the market are as close to non-existent as a statutory authority can get!)

Now, we and others (including another federal agency active on nano issues, the National Institute for Occupational Safety and Health) think EPA could and should have made the right call and declared all nanomaterials to be new chemicals – unless they are demonstrably the same as their bulk counterparts on the Inventory.  But let’s assume, for argument’s sake, that EPA’s right and that TSCA forbids it from considering size or other critical properties of a material in deciding whether it’s new.  The problem is – EPA doesn’t see any problem with this outcome!  EPA cedes its only real chance for pre-market review of these novel materials, and offers no Plan B.

It’s important to note that EPA did not rule that all nanomaterials are existing chemicals.  EPA will consider buckyballs, carbon nanotubes, anything that has no counterpart already on the TSCA Inventory to be “new.”  So the next question is, for these “new” nanomaterials, how effective is TSCA in allowing EPA to identify and address their potential risks?  We’ll turn to that question in my next post.

[Links to posts in this series: Part 1, Part 2, Part 3, Part 4, Part 5]