Hiding a toxic nanomaterial's identity: TSCA's disappearing act

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

In earlier posts (here and here), I discussed a notice EPA had received in July of 2008 from BASF reporting toxic effects at very low doses of a carbon nanotube (CNT) observed in a 90-day rat inhalation study.  In that notice, BASF had declared the specific identity of its CNT to be confidential business information, hence denying that information to the public.  Now, in a setting more to its liking, it appears the company has decided to reveal the identity after all.

The original notice was submitted by BASF as required under Section 8(e) of the Toxic Substances Control Act (TSCA).  That provision requires a company that makes a chemical to notify EPA within 30 days if it obtains new information that "reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment."

Identity hidden

BASF complied – but in doing so, claimed the identity of the nanomaterial in question to be confidential business information (CBI), requesting that it be identified only generically as "Carbon Nano Tube."  No way, therefore, for the public to tell whether it was single- or multi-walled or much of anything else about its actual identity or structure.

Identity revealed

Now, just last week BASF published a paper in the journal Toxicological Sciences that is almost certainly based on the same study.  (The abstract is publicly available, but the full paper requires a subscription.)  All of the details – the doses, number and type of animals, exposure conditions, and observed effects – match those reported in the Section 8(e) notice.

But in this setting BASF chose to fully describe the identity of its CNT, disclosing for the first time that it is multi-walled and describing other structural features in detail.

As I reported before, the study found this nanomaterial to be highly toxic, causing lung inflammation and granulomas at doses 200-fold lower than the high-concern level identified under EPA and international standards.  That makes it at least an order of magnitude more toxic than crystalline silica and – as BASF itself describes in the published paper – also at least 10-fold more toxic than nano-structured carbon black.

A major effort has been mounted in the nanotechnology community to demand that researchers fully identify and characterize their nanomaterials when publishing papers in the peer-reviewed literature, and that journals accept only such papers.  See, for example, the "Minimum Information for Nanomaterial Characterization Initiative, or Characterization Matters for short.

That likely explains why BASF provides such a full identification and characterization in its recent paper.

So why, then, did BASF claim the identity of its nanomaterial to be confidential when submitting the same study to EPA?

The answer is simple:  Because it could.

Right-to-know under TSCA:  Health impacts - yes; chemical identity - no

EPA routinely posts notices it receives under Section 8(e) in which the chemical identity, and often the submitter's identity, are claimed confidential and hence not publicly disclosed.  It's hard to imagine a less useful – and more frustrating – public disclosure system:  Some chemical is found to cause serious health or environmental effects, serious enough for TSCA to require immediate submission to EPA.  As a member of the public, you get to see just how bad the effects are – but are left to guess just what chemical causes the effects!

The ultimate insult is that, under TSCA, EPA actually should be prohibiting companies from declaring confidential the identity of a chemical that is the subject of a submitted health and safety study.

Consider:

  • TSCA itself does not preclude – and hence requires – disclosure of health and safety studies; see TSCA Section 2613(b).
  • EPA regulations clearly define chemical identity to be an integral part of a health and safety study; see the definition of a health and safety study at 40 CFR §716.3 and §720.3(k).
  • EPA regulations then do provide certain conditions under which a company may assert a confidentiality claim for the identity of a new chemical even when associated with a health and safety study. However, the regulations further state that EPA will deny such a claim unless the claimant demonstrates that "the specific chemical identity is not necessary to interpret a health and safety study." See 40 CFR §720.90(c)(3).

How could anyone reasonably argue that knowing the specific identity of a carbon nanotube is not critical to interpreting a health and safety study?  Given, for example, recent findings that multi-walled CNTs of certain lengths, but apparently not single-walled CNTs of any length, behave like asbestos, knowing a nanomaterial's identity is central to interpreting health and safety data.

Yet EPA has taken no apparent action to preclude such claims for nanomaterials.  Indeed, four of the eight TSCA Section 8(e) notices EPA has received for nanomaterials that I discussed in my earlier post had masked the materials' identities.

One possible reason why EPA hasn't acted?  Lack of EPA resources to review and challenge the thousands of CBI claims asserted annually by industry.

Given the ease with which TSCA allows CBI claims to be asserted, there is every reason to expect that many such claims wouldn't pass muster if actually examined.  A 1992 EPA study identified extensive problems with respect to the extent of inappropriate CBI claims; see pp. 32-33 of this 2005 report from the Government Accountability Office.

EPA can, of course, challenge CBI designations on a case-by-case basis, but it rarely does so because of the extensive resources required.  In the absence of a successful challenge by EPA, the information must be held as confidential.

This is a nano problem that requires a macro solution:  Fundamental reform of the CBI provisions of TSCA.  That's one of ten essential elements in TSCA reform that I discuss at length in this recent paper I published in Environmental Law Reporter.

This entry was posted in Health Policy, Nanotechnology, Regulation and tagged , , , , , . Bookmark the permalink. Both comments and trackbacks are currently closed.

One Comment

  1. Jennifer Sass
    Posted July 20, 2009 at 5:41 pm | Permalink

    Excellent post, Richard. Thanks for watching the store, and for keeping the public informed.

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