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).Â That notice certainly got the attention of lawyers in town (see here, here and here).Â 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.Â Well, as reported yesterday by Sara Goodman of E&E News, EPA is now withdrawing the SNURs, at least temporarily.Â Â Â
[Note:Â Since first posting this Friday, I have made a few changes.Â In first writing this post, I let show too much my frustration over the fact that even the smallest of steps taken by EPA to ensure some review of nanomaterials prior to their commercialization appears to have engendered an industry challenge.Â In a few places, I got too personal and took some gratuitous swipes I shouldn't have.Â I apologize for that, and have taken those out.]
The withdrawal notice is posted here.Â On one level, the withdrawal is based on a technicality.Â EPA had issued the SNURs as part of what is called a âdirect final rule,â 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).Â Such a rule applies immediately upon issuance â unless someone files, within 30 days, a notice of intent to submit âadverse or critical comments.â
Surprise, surprise, someone did just that.Â 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, âon behalf of one or more clients.âÂ (Hey, this is a regulation, after all, so itâs just begging to be challenged.Â Besides, things are kinda slow in DC during the dog days of August.)Â
Votawâs notice of intent is posted in an EPA docket you can access here.
Whatâs EPAâs next move?
Based on EPAâs withdrawal notice, EPA âintends to publish in the Federal Register, under separate notice and comment rulemaking procedures, proposed SNURsâ for the two nanotubes.Â It would then presumably proceed to issue a final rule containing the SNURs at some point.
Itâs unclear from this whether EPA intends now to proceed via full notice-and-comment rulemaking, or to reissue the SNURs via an âinterim final ruleâ (again, see p. 31299 of this 1989 Federal Register notice). Â The latter takes effect on the date of publication, even as public comment is taken and considered.Â As long as EPA promulgates a final rule within 180 days, the SNUR remains in effect during the interim.
The âinterim final ruleâ approach may well be more advisable in this case.Â 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 â but without ever having to tell EPA â simply by starting the activity identified as a âsignificant new useâ in the proposed rule before the rule goes final.Â 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.Â By definition, any activity already ongoing at the time a SNUR is issued cannot be considered a ânew useâ and hence is beyond the reach of a SNUR â it can only require notification for activities not already occurring.
Still with me?
A red herring
What Sara Goodman reports as Mr. Votawâs main problem with the nanotube SNURs is that EPA did not sufficiently identify the specific carbon nanotubes to which they apply.Â Indeed, the SNURs themselves refer only to a âgenericâ name for each nanomaterial.Â
Well, thatâs standard practice under the Toxic Substances Control Act (TSCA). Â 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.Â (EPAâs 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.Â Makers of any other nanotubes would still need to file their own PMNs.)
Mr. Votaw and his clients surely know this.Â 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, thereâs an app for that:Â They are to submit to EPA whatâs called a âBona Fide Intent to Manufacture or Import Notice.âÂ 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.Â (In case youâre wondering, as ordinary folk, you and I canât file a bona fide request, so thereâs no way for the public to participate in this ritual.)
The bigger problem
Notwithstanding the unfounded basis for Mr. Votawâs 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).Â For now, EPA has indicated it will identify nanotubes based on what company produced them (among other factors).Â So it may consider even two apparently identical nanotubes made by different companies to be different.Â
That means that future SNUR development and any evaluation of potential risks will be done on a case-by-case basis for each nanotube.Â Thatâs 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 â and if anyone objects, a notice-and-comment rulemaking â 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 ânew use.â
- A SNUR does not regulate a chemicalâs production or use; it only requires notification of EPA and provides an opportunity for an EPA review.Â Any regulation would require EPA to demonstrate âunreasonable riskâ and promulgate a separate rule under TSCAâs 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.
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.Â EDF is working within the Safer Chemicals, Healthy Families coalition to achieve this aim.Â
Among the changes we propose that are relevant in the current context are:
- Requiring that all producers of a chemical (including a nanomaterial) â whether new or existing â identify themselves to EPA and provide basic safety information.
- Requiring that any significant change in a companyâs 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 chemicalâs identity to be confidential in association with any information regarding that chemicalâs safety.
EPA must issue a test rule. Someone (OK, it was I) pointed out that, chemical structure activity wise, carbon nanotubes are just high tech carbon black, and carbon black is classified by IARC as a 2B carcinogen. It would not be surprising if nanosized CB, including nanotubes, were more potent. But a 2-year or lifetime bioassay in rats and mice is needed to establish that.
BTW, if these are SNURS, then there must be a PMN and rules following.