The nanotube SNURs: Nano step forward, nano step back

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

In June, EPA published a Federal Register notice that included Significant New Use Rules (SNURs) for two carbon nanotubes (as well as 21 other chemicals).  That notice certainly got the attention of lawyers in town (see here, here and here).  The nanotube SNURs would require anyone planning to produce or process either of the two substances to notify EPA if the person intended not to comply with the (rather limited) risk management conditions specified by EPA.  Well, as reported yesterday by Sara Goodman of E&E News, EPA is now withdrawing the SNURs, at least temporarily.

The withdrawal notice is posted here.  On one level, the withdrawal is based on a technicality.  EPA had issued the SNURs as part of what is called a "direct final rule," a mechanism EPA can and typically does use as a short-cut to get around having to go through lengthy full notice-and-comment rulemaking (see p. 31299 of this 1989 Federal Register notice).  Such a rule applies immediately upon issuance – unless someone files, within 30 days, a notice of intent to submit "adverse or critical comments."

Surprise, surprise, someone did just that.  One of those DC lawyers, James Votaw of the firm Wilmer, Hale, had the notice hand-delivered to EPA just 2 days before the deadline, "on behalf of one or more clients."  (Hey, this is a regulation, after all, so it's just begging to be challenged.  Besides, things are kinda slow in DC during the dog days of August.)

Votaw's notice of intent is posted in an EPA docket you can access here.

What's EPA's next move?

Based on EPA's withdrawal notice, EPA "intends to publish in the Federal Register, under separate notice and comment rulemaking procedures, proposed SNURs" for the two nanotubes.  It would then presumably proceed to issue a final rule containing the SNURs at some point.

It's unclear from this whether EPA intends now to proceed via full notice-and-comment rulemaking, or to reissue the SNURs via an "interim final rule" (again, see p. 31299 of this 1989 Federal Register notice).  The latter takes effect on the date of publication, even as public comment is taken and considered.  As long as EPA promulgates a final rule within 180 days, the SNUR remains in effect during the interim.

The "interim final rule" approach may well be more advisable in this case.  Otherwise, some devious DC lawyer could advise his or her clients that, if they hurry, they could engage in the very activity for which EPA intended to require notification – but without ever having to tell EPA – simply by starting the activity identified as a "significant new use" in the proposed rule before the rule goes final.  Such a client could be a downstream processor or another manufacturer of the nanotubes, as the SNURs would apply to both.

This loophole speaks more generally to the major limitations facing EPA in trying to use SNURs to regulate new chemicals or new uses of existing chemicals.  By definition, any activity already ongoing at the time a SNUR is issued cannot be considered a "new use" and hence is beyond the reach of a SNUR – it can only require notification for activities not already occurring.

Still with me?

A red herring

What Sara Goodman reports as Mr. Votaw's main problem with the nanotube SNURs is that EPA did not sufficiently identify the specific carbon nanotubes to which they apply.  Indeed, the SNURs themselves refer only to a "generic" name for each nanomaterial.

Well, that's standard practice under the Toxic Substances Control Act (TSCA).  The specific identities of the nanotubes are claimed as confidential business information (CBI) by the original submitters of the corresponding pre-manufacturing notifications (PMNs), so EPA is barred from revealing them publicly and must use a generic name.  (EPA's use of the generic name apparently confused enough folks that EPA felt obliged to email around a clarification that the SNURs do indeed apply only to the very specific nanotubes made by the companies that submitted the original PMNs.  Makers of any other nanotubes would still need to file their own PMNs.)

Mr. Votaw and his clients surely know this.  They also surely know that, if his clients really want to know whether the SNURs in question apply to a nanotube they intend to produce, there's an app for that:  They are to submit to EPA what's called a "Bona Fide Intent to Manufacture or Import Notice."  EPA then determines whether the specific nanotube the client proposes to make is or is not the same as that to which the SNUR applies, and informs them of the determination.

All of that so as not to reveal the confidential identity of the nanotubes that started all this.  (In case you're wondering, as ordinary folk, you and I can't file a bona fide request, so there's no way for the public to participate in this ritual.)

The bigger problem

Notwithstanding the unfounded basis for Mr. Votaw's concern, in light of the standard remedy EPA has provided, the fact remains that EPA lacks a nomenclature system that can distinguish between different nanotubes (or any other classes of nanomaterials, for that matter).  For now, EPA has indicated it will identify nanotubes based on what company produced them (among other factors).  So it may consider even two apparently identical nanotubes made by different companies to be different.

That means that future SNUR development and any evaluation of potential risks will be done on a case-by-case basis for each nanotube.  That's good on one level, in that their properties may well be quite specific; bad on another level, in that any SNUR will apply only to a very specific nanotube and hence does not provide a viable avenue to require notification or to regulate nanotubes more generally.

This episode also vividly illustrates how cumbersome chemical regulation is under TSCA:

  • Even to require notification via a SNUR, EPA must go through a rulemaking – and if anyone objects, a notice-and-comment rulemaking – for each and every case.
  • A SNUR cannot require notification by any companies who maintain they are complying with the conditions of the SNUR, naturally raising compliance questions.
  • A SNUR cannot reach any activities associated with a chemical that are already underway, because by definition they are not a "new use."
  • A SNUR does not regulate a chemical's production or use; it only requires notification of EPA and provides an opportunity for an EPA review.  Any regulation would require EPA to demonstrate "unreasonable risk" and promulgate a separate rule under TSCA's Section 5(f) (for a new chemical) or Section 6 (for an existing chemical), a task that has proven virtually impossible in practice.
  • In the absence of a SNUR, any company can produce and use any chemical on the TSCA Inventory under any conditions it chooses, without having to notify EPA it is doing so.

Solutions

This convoluted situation is one of many aspects of current chemical regulatory practices in the U.S. that is motivating calls for major reform of TSCA.  EDF is working within the Safer Chemicals, Healthy Families coalition to achieve this aim.

Among the changes we propose that are relevant in the current context are:

  • Requiring that all producers of a chemical (including a nanomaterial) – whether new or existing – identify themselves to EPA and provide basic safety information.
  • Requiring that any significant change in a company's production or use of a chemical automatically trigger both EPA notification and an update safety review.
  • Extending the definition of specific chemical identity to include physical as well as chemical characteristics of a substance, to ensure EPA can distinguish among nanomaterials based on more than just their underlying chemical structures.
  • Limiting the ability of companies to claim a chemical's identity to be confidential in association with any information regarding that chemical's safety.

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3 Comments

  1. Posted August 24, 2009 at 12:35 pm | Permalink

    Apology accepted. And you needn’t be so concerned. You might even thank me. There is no legal “loophole” here. As EPA's June 24 Federal Register notice made clear, use of these CNTs is already (and will continue to be) restricted by TSCA §5(e) administrative orders. These CNT have been regulated that way since as early as August 2008 when the first of two §5(e) control orders was issued after an eight month review of the submitter’s PMN. EPA’s temporary withdrawal of the direct final significant new use rule (SNUR) last week does not change that status. The contemplated SNUR will only be deferred for a time while EPA receives public comment on a narrow possible range of issues. One of those comments is likely to point out, however, EPA’s apparent error in the (withdrawn) SNUR of treating the chemical identity of the particular CNTs as confidential business information (CBI) (and, therefore, using a generic name to hide the particular identity in the SNUR) when, in fact, the submitter did not claim the identity as confidential in the PMN (the PMN is also available from the public docket). If the SNUR is issued correctly, we’ll all know upfront which particular CNT are, or are not, covered by this SNUR, and without any lengthy regulatory application process (available only to manufacturers). I’m starting to think you should take me to lunch! Best regards.

  2. Posted August 24, 2009 at 3:17 pm | Permalink

    I'm probably missing somthing, but if EPA is taking the position that the SNURs only apply to the two specific carbon nanotubes in the original PMNs, why even issue the SNURs in the first place? There are Consent Orders for these two very specific nanotubes bind any successor manufacturer or processor. Why isn't that enough? Isn't the better approach for EPA to issue a federal register notice stating that there are unlikely to be manufacturers or processors of the substance other than the PMN submitter already subject to the consent order and thus no new SNUR is necessary? 40 C.F.R. 721.160(a)(2). Why issue a SNUR and go through all of this confusion in the first place?

    BTW — Glad to see you two made up :)

  3. Posted August 24, 2009 at 4:17 pm | Permalink

    Welcome to TSCA. The consent orders are binding only on the importer who signed them. For the time being, the importer is obligated by the order to bind its customers to the same functional terms by contract. The SNUR will make the relevant order control terms (including export notice duties) directly, legally applicable and enforceable by EPA against the importer's direct and indirect customers and anyone else importing, processing or manufacturing, as you say, the "two specific carbon nanotubes in the original PMNs." It may seem a convoluted process, but this bifurcated approach is in fact a very practical (and now standard)response by EPA to avoid real world timing concerns raised by the alternatives. I'll explain over lunch.

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