It All Depends on What “New” Means
Richard Denison, Ph.D., is a Senior Scientist
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.
“New” Isn’t Necessarily All That Better
In my last post, I decried EPA’s shortsighted decision to declare nano forms of chemicals listed on the Toxic Substances Control Act (TSCA) Inventory to be “existing” rather than “new” chemicals. But I noted that EPA did not rule that all nanomaterials are existing chemicals. EPA says it will consider buckyballs, carbon nanotubes, or anything else that has no counterpart – a substance with the same chemical structure – already on the TSCA Inventory to be “new.” So can we rest assured that, at least for these nanomaterials, EPA has sufficient authority under TSCA to effectively identify and address their potential risks? Would it were so.
I’ll cover below three main questions concerning how EPA’s new chemicals review process relates to nanomaterials. First, will EPA even know that a new chemical it is reviewing is a nanomaterial? Second, will available exemptions from new chemicals review allow nanomaterials to get a free pass? And third, even when they are subject to new chemicals review, will nanomaterials get the scrutiny they need? I’ll end this post with a note about transparency – or the lack thereof.
Will EPA even know a New Chemical Notification it receives is for a nanomaterial?
Under TSCA, a manufacturer of a new chemical is obliged to notify EPA prior to commencing production or import. So the first question that arises is whether EPA would even know that a new chemical being notified is actually a nanomaterial.
The fact is that no such designation is required on the reporting form used for such notifications. (An optional worksheet that can be included with a notification does include “particle size distribution” among other properties, so if a manufacturer chose to fill out and submit the worksheet, that could provide EPA with a clue.) EPA says it has received several dozen new chemical notifications for nanomaterials, but has not indicated how many of these included an explicit identification of the substance as a nanomaterial. Indeed, EPA staff say that in a number of cases its chemists have been able to “figure out” that a notification is for a nanomaterial in the absence of such designation.
All of this begs the question of whether or how often EPA has received new chemical notifications for nanomaterials that have not been identified as such – and hence has reviewed them without benefit of such knowledge. It is baffling to me why EPA has not simply amended its notification form to make this identification mandatory and unambiguous.
Exemptions from new chemical notification requirements are unsuited to nanomaterials.
The new chemical notification required by TSCA can take the form of either a Premanufacture Notification (PMN), or a written request for an exemption from PMN requirements. There are a number of such exemptions that EPA has developed, all of which are potentially available to nanomaterials. Exemptions requiring notice and EPA approval prior to manufacture are those for test marketing (TME), low volume (LVE) and low release/low exposure (LOREX) situations.
TSCA provides two additional exemptions that don’t even require a manufacturer to notify EPA at all before commencing production or import. These “self-implementing” exemptions are for R&D activities and for certain polymers. (Bizarrely, a company making an exempt polymer must inform EPA after commencing manufacture that it has done so, but the letter need not even identify the polymer! (see answer to Question 304-1 in this EPA Q&A)) Clearly, EPA will have no idea whether a nanomaterial is being made if its producer determines it qualifies for either of these exemptions.
Over the years, EPA has developed criteria to identify chemicals eligible for the various exemptions from PMN requirements. These criteria were designed with conventional chemicals in mind, so it is perhaps not surprising that they are either inappropriate or need to be revised for nanomaterials.
The low volume exemption (LVE) is available for any chemical manufactured in quantities equal to or less than 10,000 kilograms (22,000 pounds) per year. For nanomaterials, this value raises several concerns: First, a mass-based threshold fails to reflect the fact that a nanomaterial’s “potency” is often poorly represented by mass and should instead be expressed in terms of surface area, particle count or other such metrics. Second, because many nanomaterials are indeed much more potent per unit mass – that is, they have a higher activity, reactivity, etc. – than their conventional counterparts, blindly applying the same threshold to both makes no sense. Finally, a large proportion of current nanomaterial producers likely qualify for this exemption because their production falls below this effectively much higher threshold as applied to nanomaterials.
Can EPA Track “Existing” Nanomaterials?
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.
Can EPA Get Industry Data on “Existing” Nanomaterials?
Let’s now turn to dissecting just how limited EPA’s authorities are both to collect information that companies already possess on their nanomaterials, and to require companies to generate and submit new information.
Can EPA require companies to submit information they already possess about their nanomaterials?
Many observers have called on EPA to require companies producing or using nanomaterials to identify themselves, the nanomaterials they produce, their current and anticipated production volumes and uses, and the risk management measures they employ. This step, which would equally apply to all companies, would provide EPA with a basic understanding of the full scope of current nanomaterial production and use.
EPA has authority to issue such a mandatory reporting rule – limited to one-time reporting of already available information – under Section 8(a) of TSCA. While “small manufacturers” are exempted by statute from being subject to such a rule, in this case EPA has discretionary authority to alter the definition of what constitutes a “small manufacturer.” As with the Section 8(a) rule itself, EPA would need to develop the alternate definition through full notice-and-comment rulemaking. We have discussed this authority at length elsewhere; see Appendix A of these comments EDF filed with EPA last year.
Despite the advice of EPA’s own federal advisory committee in 2005 to develop, and its own statements that it was developing, such a mandatory reporting rule to accompany a voluntary reporting program, EPA has opted to pursue only the voluntary Nanoscale Materials Stewardship Program (NMSP), which it finally launched on January 28, 2008.
While EDF (as a member of that federal advisory committee) supported a voluntary program in 2005 as one component of an overall regulatory approach, we now strongly oppose EPA’s delayed decision to rely solely on such a program as “too little, too late.” Among our reasons: Such a program is almost certain to provide EPA with only a partial – and likely highly selective or even skewed – picture of the overall nano landscape in the U.S.
Just one month away from the end of the initial six-month sign-up period, the NMSP has attracted three submissions: one from DuPont, one from OfficeZPI, and a third from an entity claiming its identity confidential. Each submission appears to cover only a single nanomaterial produced by the submitting company. In addition, ten additional companies have stated that they intend to submit information under the NMSP’s “basic” program. No commitments have yet been made under the “in-depth program.
Can EPA Regulate “Existing” Nanomaterials?
This final post in this series goes to the ultimate question, where the nanorubber really hits the road: Can EPA regulate an “existing” nanomaterial’s production, use, or disposal under TSCA?
EPA’s authority to regulate a chemical in commerce is provided in Section 6 of TSCA. In principle, EPA has broad authority to impose any of a diverse range of controls on a chemical. It can:
require labeling, monitoring, or compliance testing of a chemical or a product containing it;
require communication of instructions on appropriate use to customers;
prohibit or regulate disposal of the chemical or any product containing it;
prohibit or regulate its commercial use;
prohibit or regulate specific uses or the use above a specified concentration of the chemical; or
prohibit or limit all production or use of a chemical.
But once again there’s a big catch: For EPA to take any regulatory action, it must first find that the chemical “presents or will present an unreasonable risk of injury to health or the environment.”
To make such a finding, EPA must consider more than whether the chemical is harmful and if there are significant exposures to it.