Regulating nanomaterials to life, not death

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

As we enter a new year and legislative season, we face a changed political climate where the thought of new regulation is anything but de rigueur.  I will argue in this post that a little regulation would have done – and still could do – the world of nanotechnology a world of good.

Come again?

Back when the debate over nanomaterial safety really got started, which I would place ‘round about 2004 (or was that just my first involvement in it?), there seemed to be broad agreement on first-order needs to ensure that nanotechnology would survive and thrive.  The aim was to “get it right the first time,” by identifying and addressing potential risks up front and in the open.  That meant we needed to adequately fund and direct risk research.  We also needed to make sure adequate regulatory authority existed to address potential risks, ideally before they arose.

Most fundamentally, there was virtual consensus on the need for prompt action to ensure regulatory agencies had at hand the basic information they needed to understand the lay of the nano-land:  what nanomaterials are already being produced and are in the pipeline; in what applications and products are they being used; and where along the nanomaterial lifecycle are the most likely points for potential releases and exposures.

With respect to this most fundamental of needs, I’m sorry to say that, in 2011, we are essentially no closer to achieving it than we were in 2004. 

In a recent post to this blog, I already described the false starts that have been attempted down this path:

  • A federal advisory committee’s 2005 call for EPA to get started on developing reporting rules even as it pursued an interim voluntary program – advice EPA ignored as it took 2 years to launch a largely toothless voluntary program that yielded little information – most of it declared confidential by the submitters and hence denied to the public.
  • An unfortunate policy call in 2007 pushed hard by the industry that declared nano forms of existing chemicals to be existing rather than new chemicals under TSCA, thereby stripping EPA of its only real means of reviewing nanomaterials before their commercialization.
  • And finally, EPA’s recent effort to move forward at last by proposing some information-generating regulations – a basic reporting rule, a significant new use rule (SNUR) to partially remedy the bad 2007 policy call , and a test rule for certain nanomaterials to address critical data gaps – only to have these declared as heavy-handed regulation by the nano industry.

It’s worth reiterating than none of these modest steps EPA is seeking to propose would regulate production or use of even a single nanomaterial.  All are simply information-gathering mechanisms.

Industry seeks to enlist the new Congress to delay things even further

More evidence of industry’s retreat from its prior commitment to provide EPA with the information it needs surfaced only a few weeks ago.  That’s when the NanoBusiness Alliance (NbA) submitted its “wish list” of regulations it wants blocked, in response to the new House Oversight Committee Chairman Darrell Issa’s invitation for industry groups to identify any and all regulations they believe block job growth.

On NbA’s list?  Those TSCA regulations I just listed – regulations that haven’t even been proposed yet, which is the point at which NbA and other stakeholders would normally get to weigh in through the open, public notice-and-comment rulemaking process.  But NbA took full advantage of the opportunity to jump the gun, writing to Chairman Issa on January 7:

“Of perhaps greater concern, however, are some developments at the U.S. Environmental Protection Agency (EPA) that may adversely impact the nanotechnology industry through direct regulatory compliance costs, or more dangerously, by raising unnecessary public alarms through unfounded and inconsistent characterizations of nanotechnology materials. … Specifically, we understand EPA is working on several proposals under the Toxic Substances Control Act (TSCA) that could have an immediate and significant impact on the commercialization of nanoscale materials. These are proposals to impose regulatory requirements on manufacturers of nanoscale materials and/or the nanoscale products they produce.”

From this kind of reaction, you’d think EPA was intent on trying to regulate nanomaterials to death.

One can only hope that NbA’s opening up of this latest front doesn’t further delay when these proposed rules will finally see the light of day and be made available for public comment.  They’re currently sitting at OMB, and still within the allotted 90-day review period.

The latest wrinkle, however, is a new interagency group recently established by the White House’s National Economic Council (NEC), charged with overseeing any and all proposed nano regulatory activities.  Step one for the new group is apparently to agree to a set of principles agencies are to use to determine whether regulations affecting nanotechnology are warranted, and if so, how they are to be developed and implemented.  No deadline for issuance of the principles has been indicated, and there is also no indication as to whether any pending regulations are to be put on hold in the meantime.

One thing is almost certain:  We can expect yet more delay before EPA gets the information it needs to do its job in deciding how best to identify and address potential risks posed by nanomaterials.

Why is this information so important?  Ask the NNI

To address this matter, I’ll turn to no less an authoritative source than the National Nanotechnology Initiative (NNI) itself, the cross-government program established in 2001 to advance Federal nanotechnology research and development.

The NNI recently posted its draft Environmental, Health, and Safety Research Strategy.  The 100+ page document is rife with statements all but begging for precisely the kind of information the EPA rules would provide, and identifying the lack of such information as a critical data gap.

Here are some representative excerpts (with page numbers, emphases added):

  • Key data gaps/needs:
    • Systematically collect and analyze information about nanomaterial manufacture, processing, and direct use in consumer products.” (p. 21)
    • “Critical research gaps include … data on emission sources (types, rates, locations, etc.), manufacture of nano-enabled products (processes, types of nanomaterials, etc.).” (p. 24)
  • “There should be an expectation that the private sector will provide adequate information to enable policymakers and members of the public to understand and make decisions regarding possible exposures to nanomaterials.” (p. 25)
  • “Inventory databases of production and use information should be developed…. Populating such databases implies a shared responsibility and commitment by industry and government to make information available that, while addressing confidential business information needs, also provides the public with information on how much of what kinds of materials are being produced for what uses.” (p. 43)
  • Critical gap:  “Understand environmental exposures through identification of principal sources of exposure and exposure routes:  Manufacturing processes and product incorporation; Life cycle of technology and exposures subsequent to product manufacturing.” (p. 44)
  • “As the use of nanomaterials increases rapidly, it is of vital importance that the risk assessment community understands the complexities of the issues surrounding the manufacture, use, and disposal of nanomaterials, the potential of environmental and occupational exposure to human populations, as well as potential adverse health outcomes…. The lack of such data severely hinders our ability to intelligently assess and manage the potential risks of nanomaterials.” (pp. 57, 59)
  • “A systematic approach to gather and evaluate information is needed to develop a more realistic view of the potential impact of nanomaterials on the workplace.” (p. 61)

And remember, this report is from the Federal entity charged with promoting nanotechnology.

I’ll end this post with a recap of what I said in my last post on this subject:

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.

A little regulation could go a long way toward restoring confidence in our ability to produce and use these emerging materials in a manner that reaps the benefits and avoids the harm they may otherwise cause.

That’s what I mean when I say there’s such a thing as regulating nanomaterials … to life.

You’d think the industry would get that.  I can only hope the good folks at OMB do.

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

3 Comments

  1. josephguth
    Posted January 28, 2011 at 12:17 pm | Permalink

    The thing that is maddening about this debate is the way the environmentalist position is framed by industry and too often the media. I believe the environmentalist/public health advocates majority position is that what is important is that the nanotechnology industry develop products that are safe for human health and the environment. Unless we think that all nanoproducts are inherently hazardous, this is not an objection to the entire industry nor a philosophical or moral objection to materials constructed on a nanoscale (as there can be to genetically engineered materials, even if they are safe).

    The industry cannot be directed along a path of developing safe products unless there exists a set of incentives and disincentives that distinguish between safe and unsafe products. Can anyone dispute that proposition? It is also clear that there is no such set of incentives and disincentives governing today's market for nanomaterials. Modern private tort law principles are completely ineffective, so TSCA is our only current means of creating a distinction between unsafe and safe materials that the market and legal system could respond to.

    Industry avoids this issue by successfully characterizing the regulatory position as one that is hostile to the entire industry, so it becomes one of a tyrannical government vs. jobs and the future. What I would like to see is industry forced to defend itself on actual ground in dispute: whether it should be free to market dangerous products as well as safe ones and if not, how it proposes to distinguish the one from the other.

  2. Posted January 31, 2011 at 6:09 pm | Permalink

    this is nonsense. in over a dozen years of research and development in nanomaterials and germinal production of nanomaterials and incorporation of nanomaterials into larger or other products, there is not a single case of disability or provable human harm from products at the nanosize. We've been breathing smog for years in cities and had nano particles in the air from carbon black in tires plus had the inclusion of nanostuff in cosmetics and anti bacterial formulations for many years and nothing fatal or long term harmful has ever been directly proven to be caused by the nanopart of any product. The scare tactics of the press and so called 'safety minded" professionals, without any supporting data has unjustifiably hurt the prospects and the image of the nanotechnology industry.. The FDA has applied it's health processes to nanosized particles and determined that the have adequate regulations… etc. Basically, Denison is a speculator in scare due to possible nanotech harm… for the purposes of self promotion and headline seeking. that's why self regulation is working and needs no regulatory help other than what regulations current govern production, sale and use of such products.

  3. Posted February 2, 2011 at 3:00 pm | Permalink

    I'll respond to Mr. Shalleck by letting a few pictures speak a thousand words:

    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2958975/figure/F4/

    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2958975/figure/F7/

    Richard

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