Nanotechnology Law Report’s own John Monica was recently interviewed by Melina Vissat, the news editor of “The Rose Sheet,” published by FDC Reports and formally known as the Toiletries, Fragrances & Skin Care on-line trade report.  The interview was a followup to John’s recent presentation on the perils of preemptive nanotechnology litigation at a recent conference regarding the regulation of nanotechnology in consumer products, in Washington, D.C.  Ms. Vissat’s interview is below the fold.

MV: Why would Berkeley, specifically, make this a regulation? Is there a lot of handling of nano-materials there? Or would this set precedent for California state, and/or perhaps the rest of the country?

JCM: The short answer is Berkeley primarily wanted to be a trendsetter, and secondarily wanted a forward looking ordinance to prevent any potential future problems. Officials in Berkeley have openly criticized the federal government and the state of California for failing to enact nano-specific safety regulations. They have also openly said they enacted their own ordinance because state and federal governments failed to act first. Also, while the ordinance is not binding legal precedent, Berkeley has openly encouraged other governments — city, state, and federal — to follow their lead.

As for actual application, currently there are very few companies using engineered nanoscale materials in Berkeley. (In fact, several newspapers have reported there are "none," but I do not believe this is accurate.) So, I would not say the ordinance was enacted because of any impending current safety concern.

On the other hand, University of California Berkeley labs and Lawrence Berkeley National Laboratory are both in the city limits. Both are involved in nanomaterials research. Berkeley says the ordinance was initially prompted by a lack of nanomaterials handling procedures at these two labs. The city claims to have asked the labs what nano-specific safety procedures they had in place, and the answer was "none or very few." This prompted Berkeley’s original concern and ultimately the ordinance. However, Berkeley has also now stated that the ordinance does not apply to either lab because they are federally funded. The labs, on the other hand, intend to voluntarily comply with the final ordinance.

MV: Why specifically is this legislation unnecessary? Is it because we don’t yet know whether nanomaterials are actually a threat? Or because there is simply a lack of data proving either way – dangerous vs. safe?

JCM: I believe this specific legislation is unnecessary because (i) it is virtually impossible to comply with in its current form, (ii) the federal government should take the lead in labeling any material/chemical as "hazardous," not Berkeley (iii) all "manufactured nanoparticles" – whatever that broad definition used in the ordinance implies – have not been label as "hazardous," nor is there any current scientific consensus that they all should be.
There are data on both sides of the safety/hazard issue, but I do not believe any responsible scientist is dismissing the potentially negative data out of hand. It is a real concern. However, most scientists say more research is still needed and it will take several years. They also advocate the standardization of research techniques to make sure they are all talking about the same thing as they move forward with research.

MV: Who should be doing this research to determine whether nanomaterials are safe? Companies, etc.?

JCM: The federal government is funding nano-related environmental, health, and safety research – about $44 million is in the 2007 budget. However, there seems to be a consensus among scientists that federal funding should be increased to at least $100 million annually. On the other hand, the federal government takes the position that manufacturers are primarily responsible for the research necessary to ensure the safety of their nano-products. Ultimately, product liability law imposes this same burden on manufacturers. As they must ultimately bear the social and financial burden of any liability, I believe manufacturers should plan accordingly. However, my personal belief as a policy matter is that manufacturers and the federal government have equal responsibility.

MV: Now, regarding this regulation, who does the burden fall to to provide the required information? The companies? Will this cost companies time, money, manpower? Could you please provide more detail on how this legislation is a burden to industry?

JCM: The burden falls on the companies to provide the required toxicology information. There are a couple of ways to answer the question depending on what the city wants, which isn’t crystal clear.
If the city says all that is required is a literature search (most likely), then my response is that reviewing the universe of existing toxicology studies and then reporting/summarizing them to the city is a very expensive prospect. You will have to ask a toxicologist for an estimate of the actual hours this research would take. There are over 1600 EHS studies in the best nano-database. A lot of them, of course, might not be applicable to any individual company or situation. But if you take the Cosmetics, Toiletry and Fragrance Association’s white paper on nanoparticles in personal care products to the FDA as an example of the type/level of analysis required, the required effort will be quite large and expensive indeed.

If new toxicology research is required (less likely), then that is a whole different (greater) level of expense.  There are also additional expenses associated with implementing the materials handling plan portion of the ordinance once the toxicology issue has been resolved. Of course, this is hard to estimate without having the toxicology part nailed down.

MV: Where else is this pre-emptive legislation surfacing?

JCM: This same type of current preemptive legislation is being considered in Cambridge, Massachusetts. I would look for similar efforts in nano-university communities across the country. Additionally, companies located in "top ten" states for nanotechnology development should be closely watching what’s going on at the municipal level.

MV: Also, at what stage would it NOT be considered pre-emptive? Once safety data is in-hand?

JCM: City governments are not well-equipped to analyze these issues. Thus, I would always consider municipal regulations of this specific type to be "preemptive" and ill-advised. The federal government is looking very closely at nano-EHS issues, I would leave the decision to it as to whether or not to label a nanomaterial as "hazardous" and all the burdens that come with that label.