Richard Denison, Ph.D., is a Senior Scientist.
I just read an interesting column by John DiLoreto, CEO of NanoReg, that appears online at Nanotechnology Now. It’s titled “We Should Have Seen It Coming: States Regulating Nanotechnology.” It nicely describes the important role states play in advancing environmental policy and regulation – especially when the feds are asleep at the wheel. And it also gives a neat rundown of the various state actions aimed at nanomaterials that are underway.
But, search as I might, I couldn’t find a single acknowledgment in Mr. DiLoreto’s latest column – or in his earlier related column titled “What Drives the Regulation of Nanomaterials?” – of the role the nanotechnology industry itself played in bringing all of this on itself.
That’s quite an omission, in my view, given that the industry’s actions (or, more accurately, the lack thereof) played a central role in getting us to where we are (or, more accurately, aren’t) today on nanotechnology oversight. That includes driving states to feel they had to step in to fill the federal void.
In the nearly seven years I’ve followed the issue, the principal stance of the industry, with some exceptions, has been to urge or compel the federal government to “slow-walk” nanotechnology oversight. That includes seeking to block or slow down even modest proposals by the U.S. Environmental Protection Agency (EPA) to obtain better information about nanomaterials in or about to enter commerce.
Here are a few examples:
- The industry fought hard for and was instrumental in securing a policy decision by EPA in 2007 that declared nano forms of existing chemicals to be existing rather than new chemicals, thereby removing the only means under the Toxic Substances Control Act (TSCA) by which EPA could have reviewed such nanomaterials before they entered commerce and taken any steps needed to protect the public or the environment.
- Despite the recommendation of a multi-stakeholder advisory panel convened by EPA back in 2005 that the agency simultaneously advance both mandatory and voluntary vehicles to maximize development and reporting of information about nanomaterials, the industry helped convince EPA to move forward only with a voluntary reporting program.
- Despite EPA eating up more than two years to launch the voluntary program, and despite EPA’s efforts to beat the bushes to get companies to volunteer, the industry delivered only paltry participation in the program. EPA’s own analysis found that it had received only limited information on less than one-tenth of the nanomaterials it identified as already in commerce, and even some in industry acknowledged the industry response had been “lukewarm at best“.
- EPA was unable to provide public access to most of the information that was volunteered, because of rampant industry claims for protection of the information as confidential. This, despite industry lip-service paid to the need for transparency and stakeholder engagement, and EPA exhortations to the industry that it please, please refrain as much as possible from asserting confidentiality claims.
- As the new leadership at EPA began last year to try to use its limited regulatory authority under TSCA, some in industry have challenged and sought to delay even the most modest steps, such as those that would merely require a company to notify EPA of its intention to manufacture a carbon nanotube in a manner that differs from that previously reviewed and approved.
Indeed, in recent months, as EPA has begun to resuscitate itself and start pursuing nano-specific data call-ins, Significant New Use Rules (SNURs) and test rules, I have been quite amused to see these mere notification and information development instruments be described by the industry – including by Mr. DiLoreto – as the heavy hand of government regulation of nanomaterials. Yet not one of these actions would actually regulate, i.e., place any restriction at all on the production or use of, any nanomaterial.
All of this foot-dragging by industry has real consequences for public acceptance of nanotechnology. Today – 6 years after EDF first wrote to EPA to raise concerns about its oversight of nanomaterials under TSCA – EPA and the public know little more about which nanomaterials are being made, in what quantities, by whom, for what uses and with what associated risks than we did back then. And government is no closer to being able to demonstrate to the public that the products of this industry are safe.
Mr. DiLoreto concludes the earlier of his two columns with this:
“Clearly, the real danger here is an over-stimulated, political regulatory process that results in a reduction in the research and development of nanomaterials and one that provides a chilling effect on the growth of nano-enabled products.”
Hardly. The real danger 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.
That is why whenever there’s a sign of trouble – such as last year’s studies showing multiwalled carbon nanotubes can act like asbestos fibers, or last month’s field study reported in Scientific American, showing that relatively low concentrations of nanosilver particles in soil suppress plant growth as well as microbial activity – all the same questions about safety and adequacy of oversight pop right back up to the surface.
That in turn leaves the nano industry flying through the air without a safety net, literally and figuratively, between it and the risk of rapid public rejection of this clearly promising set of technologies.
It’s high time the industry acknowledge its role in bringing all this about.
2 Comments
It is always difficult to step into the middle of a discussion and attempt to provide a third perspective. The blog by Richard Denison, Ph.D., “State-level nano regulation: Yes, indeed, the industry ‘should have seen it coming’ – it caused it!”, in the Environmental Defense Fund site addressing the column by John DiLoreto, CEO of NanoReg, titled “We Should Have Seen It Coming: States Regulating Nanotechnology” are two sides of a coin. One side stating that the states are attempting to move into the regulation of the nanotechnology industry with the potential of inhibiting growth and the other side where the industry needs to be more proactive in developing the safety measures to guarantee that there will not be negative impact on people or the environment for any applications of nanotechnology. This is addressing the wrong issue at this time.
In reality, we do not understand enough about nanomaterials to be able to properly regulate the industry. Companies are working to protect their workers and safely apply nanomaterials to enhanced products. However, there is not enough information to be able to proceed in reasonable manner. There are numerous examples of our inability to evaluate the potential interactions of the materials with people or the environment. Silver nanoparticles are one such example. At sizes below 30 nm, they have properties that can prevent infections and effectively accelerate healing of wounds. This same ability to kill bacteria becomes a challenge if the nanoparticles are in the environment and capable of killing beneficial bacteria. There are a number of examples of the good/bad effects of silver nanoparticles. It has been shown that silver nanoparticles can have a healing effect in the brain and counteract the effect of alcohol. However, there have been reports of magnetic particles having a detrimental effect on brain function. Why is this statement important? The reason is that 13 atoms of silver has been shown theoretically to have a magnetic moment!
Agencies have provided many opportunities for companies to simultaneously do the correct thing and not be in compliance. One example is the U.S. Environmental Protection Agency’s Office of Pesticide Programs (OPP) has come out with its definition of a “nano-scale material”: “an ingredient that contains particles that have been intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers,” along with a new policy stating that an active or inert ingredient will be considered new if it is nano-scale. But the size-based focus of that definition is different from the one used by the EPA’s Office of Pollution Prevention and Toxics (OPPT), which says size alone does not determine whether or not a chemical is new, and therefore subject to review under the Toxic Substances Control Act (TSCA). Manufacturers of nano-engineered products are getting frustrated by the uncertainties about the regulatory definitions of chemicals, materials, and products made with nanotechnologies. [From Meridian Institute Nanotechnology Portal on Tuesday, May 18, 2010 http://www.merid.org/NDN/%5D How does a company proceed and stay in compliance? For example, if a regulation is passed, like the City of Berkeley’s requirement to have MSDS (Material Safety Data Sheets) for nanomaterials brought into the city for research, and the MSDS does not exist, how can a company comply? If a MSDS did not exist for carbon nanotubes, would not an MSDS on graphite suffice? What is the alternative? Should there be no research because there has not been the full evaluation (five plus years) of a new material? Obviously, there is a need for a comprehensive strategy.
Nanomaterials are chameleons. CeO2 10nm shifts toward {111} octahedron. [Waychunas, Glenn A., Hengzhong Zhang. Structure, Chemistry, and Properties of Mineral Nanoparticles. December 2008 issue. Elements. Vol. 4, pp381-387.] According to Michael Hochella [Hochella, Michael F. Jr.. Nanogeoscience: From Origins to Cutting Edge Applications. December 2008 issue. Vol. 4, pp. 373-379] nano-sized metals exist in five different states: as hydrated atom; metal complexed in a small protein; metal adsorbed to surface on 1nm mineral particle; metal adsorbed to surface of 20nm particle; the same except to a 200nm particle. 13 atoms of platinum have been experimentally shown to have a magnetic moment. We really don’t know all the possibilities of nanomaterials, much less have been able to evaluate their effects.
Company size is a determent. When the semiconductor industry had an issue with potential chemical impact, it was able to pull together support to address the issues. The semiconductor industry is composed of a small number of very large companies with significant revenues. The ability to leverage the revenue flow to address issues has an impact on their total operational costs, but it is not a large percentage. This is not the situation with startups and small companies involved in nanotechnology. The barrier to entry in semiconductors is the significant cost of the facilities. That financial barrier does not exist for many applications of nanotechnology. Consequently, there are many companies delving into the nanotechnology development effort. The vast majority of them do not have the capacity to fund a large effort on developing the full understanding of the nanomaterial properties. In addition, the time to do a full evaluation of the impact on the nanomaterials’ impact on people and the environment is beyond the life of many emerging companies.
What needs to be done? We need to approach the issue in a systematic manner. What we are currently doing is aiming at any target (the target du jour) without looking for a systematic solution. My 2007 white paper on NANO-SAFETY [linked at http://www.nano-safety.info] provides four elements that comprise the nanotechnology safety issue. There is a conference in October 2010, Rice University’s “Year of Nano” [http://buckyball.smalley.rice.edu/year_of_nano/], which has a “Nanotechnology Occupational EH&S” session on Tuesday afternoon October 12, 2010, chaired by Prof. Kristen Kulinowski, addressing various issues involved with nanotechnology. [Full disclosure: I am presenting “Needed: A Strategy for Nanotechnology Safety” at this session of the conference.] While there has been some progress in addressing the elements, especially in the educational focus, the progress has been too limited. What is needed is a national (global?) strategy to provide a systematic approach to identifying, correlating, and categorizing the potential dangers and the possible solutions.
Dear Walt: Thanks for your detailed comment, to which I will only post this brief reply, it being late on a Friday. I completely agree with you as to the complexities involved in trying to get a handle on nano safety, given the sheer diversity of materials and applications, as well as the inadequacy of the database on nano safety and the constraints it places on government’s (and industry’s) ability to design appropriate regulations/safe practices. My frustration with the industry (and I realize that is perhaps too broad-brush) is that it has often stymied efforts by EPA even to get basic information about nanomaterials already in use or in the pipeline. You will notice that all of my examples were efforts by EPA, not to limit or control development or use of a nanomaterial, but only to get better information. The lack of progress even in this basic information-gathering step is a significant reason, in my view, as to why we haven’t made much progress over the last 5 years, and why we’re still organizing and attending the same meetings as we were 5 years ago on topics like “Needed: A Strategy for Nanotechnology Safety.”