Why is the nanotech industry so intent on keeping EPA from doing its job?

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

Ten years and counting.  That’s how long EPA has been trying to gather the most basic information on nanoscale materials in commerce.  And that’s how long the nanotech industry has been throwing up roadblocks – despite its rhetoric that it supports EPA’s effort, which it sees (in theory) as a means to “favorably and efficiently address unwarranted concerns that have been raised” about the products of nanotechnology.  This “say-one-thing, do-another” approach is both unfortunate and ironic, given that it has stymied getting to a well-informed government oversight system for nanotechnology that the industry should recognize is in its own best interest.

The latest round comes in the wake of EPA’s proposal of a reporting rule under the Toxic Substances Control Act (TSCA) that would call on makers and processors of nanoscale materials – those in the size range of 1-100 nanometers (nm) – to provide the agency with information relating to the materials’ manufacture, processing and use, as well as available data relevant to understanding their potential exposures and health or environmental impacts. Here’s EPA’s succinct summary of the rationale for the rule:

Nanoscale materials have special properties related to their small size such as greater strength and lighter weight, however, they may take on different properties than their conventionally-sized counterpart. The proposal is not intended to conclude that nanoscale materials will cause harm to human health or the environment; Rather, EPA would use the information gathered to determine if any further action under the Toxic Substances Control Act (TSCA), including additional information collection, is needed.

Despite this modest, common-sense objective, the proposal was met with vociferous opposition from the nanotech industry.  

Particularly strident were the NanoBusiness Commercialization Association and the NanoManufacturing Association,[1] each of which filed 30-plus pages of comments challenging virtually every aspect of EPA’s proposal.  Other industry groups also criticized the proposal, including the Society of Chemical Manufacturers and Affiliates (SOCMA), SOCMA’s Nanotechnology Coalition, the Chemical Users Coalition, and the American Chemistry Council’s Nanotechnology Panel.  (See comments of these and other industry organizations in the docket for the proposed rule here.  It should be noted that EPA also received many comments supporting its proposal or arguing that it did not go far enough, including comments from EDF.)

Industry commenters have variously called for EPA to withdraw the proposed rule, and either start over from scratch or forgo it altogether.  Many of the comments fall into the category of “Don’t make us do this at all,” or “Don’t make us do this until later,” or “Okay, but exempt most of the nanoscale materials we make or use.”  Ten years ago some of these stock demands might have held water, but coming after the repeated pushes since then by the industry to delay, dilute and deflect EPA’s voluntary and regulatory efforts – which have denied EPA and the public the information needed to understand the nature and extent of nanoscale materials in commerce – those demands warrant scant consideration.

Most galling are the industry’s calls for EPA to wait until it can specify in minute detail every aspect of the proposal – precise test methods for nano-specific properties; delineation of exactly how the information will be used; identifying nanoscale materials subject to reporting based on evidence of risk – all of which put the cart far ahead of the horse because they would require EPA having access to the very information it is seeking to collect via the reporting rule!

Industry also urges EPA to allow reporting of information in a manner that does not distinguish between bulk and nanoscale forms, or between different nanoscale forms, of the same chemical structure – an approach that would defeat the very reason for requiring reporting in the first place.  It is precisely the variability and nature of engineered changes (even if quite subtle) in size and other characteristics of nanoscale materials that imbue them with unique or enhanced properties; EPA needs information at that level of granularity in order to begin to understand how such variation or changes influence the fate and behavior of nanoscale materials in ways that may be risk-relevant.

Long history of industry opposition

Unfortunately, none of this resistance from the industry is new; indeed, this latest round is déjà vu all over again.

It has been 10 years since a federal advisory committee that included industry participants identified the development of reporting rules for nanoscale materials as a near-term need.  EPA indicated at that time that it was initiating such an effort, alongside development of a voluntary reporting program – which ultimately drew only paltry industry participation and yielded little useful information.  I’ve recounted several times on this blog the long, sad history of this ill-fated endeavor by EPA and the active effort of the nanotech industry to thwart it; see here, here, and here.

Given the history-repeating-itself nature of this ordeal, I have neither the space here nor the patience to rebut the slew of beefs the industry has voiced over EPA’s current proposal.  But I do want to take up a couple of claims made by the NanoBusiness Commercialization Association (NanoBCA), as they strike right at the heart of EPA’s ability to address nanoscale materials under TSCA.  The NanoManufacturing Association and ACC’s Nanotechnology Panel made similar claims.

Smoke and mirrors

NanoBCA’s main argument is that EPA cannot require reporting specifically of nanoscale materials under TSCA because TSCA doesn’t allow EPA to distinguish nanoscale materials from their bulk counterparts (i.e., larger-sized versions of a material with the same chemical structure).  This line of argument first surfaced ca. 2007 when EPA was considering whether nanomaterials were “new chemicals” under TSCA.  Specifically, the question was whether or not new nanoscale forms of chemical substances whose bulk forms were already in commerce should be treated as new chemicals under TSCA.  Such a designation would require companies to file premanufacture notifications (PMNs) and would afford EPA an opportunity to review their safety prior to commencement of manufacturing.

In 2007, EDF and the National Institute for Occupational Safety and Health (NIOSH), among others, argued that EPA has full authority – as well as strong policy reasons – to designate new nanoscale forms of existing substances as new substances under TSCA.  (Note that the California Department of Health filed comments on EPA’s current proposed rule calling on the agency again to take this approach.)  Nonetheless, in 2008, EPA issued a policy statement indicating that it would not consider new nanoscale forms of chemical substances whose bulk forms were already in commerce as “new chemicals” under TSCA.

Blurring the distinction between premanufacture notification and reporting

EDF continues to believe that EPA made the wrong policy call in 2008 – on both legal and policy grounds – with respect to whether new nano forms of existing substances are new chemicals. But even if one accepts EPA’s position with regard to premanufacture notification under Section 5 of TSCA, NanoBCA in its comments tries to extend this line of argument far beyond that limited context.  It argues that EPA cannot require reporting under TSCA Section 8(a) of different nanoscale forms of a chemical substance.

But it simply does not follow that Section 8(a) or any other provision of TSCA precludes EPA from collecting information on differences with respect to the same chemical substance.  EPA can and does routinely require separate reporting:  by different companies making the same chemical, or by the same company making the same chemical at different sites; of different processes used in the manufacturing or processing of the same chemical; of different uses of the same chemical; of different byproducts resulting from the manufacture, processing, use or disposal of a chemical.

Getting information on these differences is important, as they can bear directly on the potential for exposure and risk.

TSCA Section 8(a) gives EPA broad authority to require reporting related to chemical substances “as the Administrator may reasonably require.”  It imposes only two limitations on that authority with respect to requiring reporting in different settings involving the same chemical substance.  EPA cannot require reporting of:  (a) “a chemical substance in small quantities (as defined by the Administrator by rule) solely for purposes of scientific experimentation or analysis” or (b) “changes in the proportions of the components of a mixture” unless the reporting “is necessary for the effective enforcement” of TSCA.  Outside of these two limitations, EPA can require reporting of information that differentiates between the different circumstances under which the same chemical substance is manufactured, processed, distributed, used or disposed of.  And that in turn can encompass information on different forms of a chemical substance, including those at the nanoscale.

In sum, NanoBCA’s argument seeks to obscure and confuse what are clearly two distinct aspects of TSCA:  Circumstances that define when a substance is considered “new” and hence requires premanufacture notification (pursuant to Section 5); and EPA’s authority to require reporting of information on chemical substances (pursuant to Section 8), which clearly may include information that characterizes variability or differences in the composition or activities associated with a chemical substance.  The former is tied to TSCA’s definition of a chemical substance, while the latter is not.

Seeking to constrain what information EPA can collect on existing nanoscale materials

NanoBCA also makes the astounding claim that “[t]he manufacturer or processor of such [nanoscale] chemical substances is not required to provide EPA with information on the size or the related properties of a nanoscale chemical substance, unless the substance is a new chemical substance for which notification is required under TSCA Section 5(a).” (page 7)  Again, nothing in TSCA supports such a claim.  (Note that the information TSCA requires companies to provide EPA in their Section 5(a) notices for new chemicals is actually specified under Section 8(a), which Section 5 expressly cross-references (see Section 5(d)(1)).  In other words, the information required for new chemicals is the very same information EPA is authorized to require be reported under Section 8(a) for existing chemicals.)

NanoBCA’s point that EPA can only require reporting under Section 8(a) of information that already exists is correct, of course – as is readily acknowledged by EPA in its proposed rule (see proposed section 704.20(d) on p. 18341 of the Federal Register publication of the proposed rule).

Ironically, later in its comments, NanoBCA argues the opposite of its earlier claim, and in the process also makes a statement that supports the view (long held by EDF) that properties such as particle size are part of the “chemical identity” of a chemical substance (and hence can be used as a basis to distinguish among nanoscale and bulk forms of chemical substances with the same chemical structure).  NanoBCA states:

[S]ince morphology data may be necessary to determine the “molecular structure” of a chemical substance, and particle size and surface modification data are arguably pertinent to the “chemical identity” of a chemical substance with a given molecular structure, it appears that EPA may have sufficient authority under TSCA Section 8(a)(2)(A)40 to require reporting of these types of data in those instances where they exist. (page 24)

Why does this matter?

These questions are not merely academic:  They go directly to the heart of what makes nano nano.  The nanotech industry is all about new and different.  The entire rationale for engineering materials at the nanoscale is to impart them with new and different properties.  While that is done for reasons of performance, it doesn’t take a rocket scientist – or nanotechnology engineer – to recognize that changes in the core properties of a material may alter its behavior in the environment or when it comes into contact with biological systems in ways that could affect its risk potential.

So it’s particularly vexing to have the very industry that best understands how different nanoscale materials are from their conventional siblings turn around and play dumb when it comes to EPA’s modest efforts to better understand the health and environmental implications of those differences.  In seeking to erect legal barriers to EPA’s authority to gain a better understanding of nanoscale materials, NanoBCA and other industry commenters on EPA’s proposed rule would have us believe that there’s nothing new here that EPA needs to know about.  That’s hypocritical.

None of this is about unfairly stigmatizing nanoscale materials; rather, it’s quite the opposite.  As I said in a 2011 post to this blog:

The real danger to the future of nanotechnology is continuation of a government oversight system that is too antiquated, resource-starved, legally shackled and industry-stymied to provide to the public and the marketplace any assurance of the safety of these new materials as they flood into commerce.

[1] It is not clear who the NanoManufacturing Association represents, as neither their comments nor their website provide any listing of members.  A footnote in NMA’s comments merely indicates it is “an alliance of private companies and trade associations.”  The comments were prepared and filed by Keller and Heckman.  In contrast, the members of the NanoBusiness Commercialization Association, SOCMA’s Nanotechnology Coalition, the Chemical Users Coalition, and the American Chemistry Council’s Nanotechnology Panel are identified in their comments and/or on their websites.