EPA Nano Authority under TSCA, Part 3: Can EPA Track "Existing" Nanomaterials?

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

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

This was going to be the last post in my series on the fate of nanomaterials under the Toxic Substances Control Act (TSCA), where I turn to what will likely be – at least in the near term – the most common regulatory scenario that will apply:  the extent to which EPA has authority to regulate nanomaterials as “existing” chemicals under TSCA.  But there’s so much to cover that I’ve decided to split this last topic into three separate posts. 

This post will cover whether EPA can effectively track existing nanomaterials in commerce.  The final two posts will then address these questions:

  • Can EPA readily obtain information that companies already possess on their nanomaterials?  And can EPA compel companies to generate and submit new information?
  • What burdens must EPA meet to actually regulate the production, use, or disposal of an “existing” nanomaterial under TSCA?

So let’s turn to whether EPA will be able effectively to track nanomaterials in commerce.  EPA is authorized and required under Section 8 of TSCA to maintain and update an inventory of existing substances.  The updating is done periodically through the so-called Inventory Update Rule, or IUR, through which EPA can track chemicals once they are in commerce.

But here are five big catches:

First, the update is done only once every five years, and then only for a single year out of those five.  This is despite the well-known fact that chemical production fluctuates dramatically over time, so that such reporting provides only a blurry snapshot of actual production.

Second, only substances produced in amounts of 25,000 or more pounds per year per manufacturing site are subject to reporting.  This quantity is a lot even for a conventional chemical;  given that most nanomaterials have greater “potency” (increased activity per unit mass), this high threshold means that the production of very few nanomaterials will be required to be reported, until and unless they attain quite substantial levels of production.  Indeed, 2008 data on production volumes for various classes of nanomaterials compiled by Lux Research suggest that only carbon nanotubes and certain ceramic nanomaterials (e.g., nanoclays, nanotitania) would likely surpass this threshold.

Third, there are a number of exemptions from IUR reporting (see pages 7 and 8 of this EPA Q&A).  Reporting is not required if the substance:  is a polymer; is produced in small quantities for research and development; is imported as part of an article (e.g. consumer product); or is manufactured by a company that qualifies as a “small manufacturer.”  All of these exemptions could of course apply to many nanomaterials;  in particular, many or most companies making nanomaterials are likely to meet one of the definitions of a "small manufacturer," which is a company that either:  has less than $40 million in annual sales and produces no more than 100,000 pounds of the substance per year at any given site owned by the company; or has less than $4 million in annual sales, regardless of the substance’s production volume.

Fourth, IUR reporting does not require companies to identify the substances they are reporting as nanomaterials;  indeed, nothing under the IUR requirements would require that nano forms of existing conventional substances be separately noted, and the TSCA Inventory itself makes no such distinction.  (Ironically, this is a consequence of EPA’s failure to consider more than chemical structure for the purpose of listing substances on the Inventory, as discussed at length in my first post in this series.)

Finally, companies submitting information under the IUR have wide latitude to claim such information – including the identity of a given substance and their association with it – as confidential business information (CBI).  Once so claimed, any access by the public or other governments – whether domestic (e.g., state or local) or foreign – is precluded.  While this CBI allowance is available for all substances, such claims are even more likely to be made for nanomaterials that – despite being regarded by EPA legally to be “existing” – are actually new to the market.

So, it seems that many or most nanomaterials will simply be missed by TSCA’s current reporting mechanisms, or if they are caught, no one will be able to tell that they’re included.

Check back soon:  My next post will address the questions:  Can EPA readily obtain information that companies already possess on their nanomaterials?  And can EPA compel companies to generate and submit new information?

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

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