1:30-3:30 pm EHS Workplace Practices [Room 351 CF]
[This is part of a whole track on EHS that begins at 10:30 am with a session on Nano Toxicology Studies]
2:00-4:00 pm I will be in the Expo [Rice Booth 901] to answer questions about CBEN or ICON.
5:00-6:00 pm ICON reception at the Expo [Rice Booth 901]
10:30 am GoodNanoGuide Sneak Preview [Room 361 CF]: A hands-on demo of our newest project. Please bring your wireless-enabled laptop to take the GoodNanoGuide for a spin.
I hope to see you there!
Janelia Farm, a Howard Hughes Medical Institute located outside Washington, DC, was the picturesque setting of HHMI’s annual Environmental Health & Safety Directors Conference. The theme this year: Nanotechnology and the New Economy—Modern Challenges in ES&H Management. In the audience were about 50 high-level EHS managers at universities that are part of the HHMI network. The level of prior knowledge about nanotechnology was mixed. As we learned, some were very knowledgeable, others knew in which labs nanotech research was being pursued at their institutions, and a few had little more than passing knowledge.
The science keynote address was given by Drew Endy, PhD, assistant professor of bioengineering at Stanford University. A very interesting and provocative speaker (though in an unassuming way), Endy gave a series of slides he calls “postcards” outlining the ways in which synthetic biology is being developed. His presentation style consisted of speaking to the audience using slides with minimal content, except when needed to illustrate a technical point. (I liked this approach better than the “stuff lots of content onto your slides so people would not even have had to be there to get the gist. Which usually doesn’t work.) So quotable was he that my Twitterstream on this (#HHMIEHS) does a better job capturing the highlights than I can do here. Suffice it to say that Endy effectively presented a lot of the cutting edge developments in synbio, if he fell a tad short on offering advice to EHS managers about how to handle safety issues in their institutions. The closest he came was an illustration of a student’s home-brew synbio lab, constructed in her bedroom closet, in which her coat was clearly visible among the instruments. I had the same reaction to his talk that I had to the synbio thread at last summer’s GRC on Science and Technology in Society: Wow.
My session was entitled, “Nanotechnology & Safety Management—A New Relationship”. Joining me were Jo Anne Shatkin, PhD, Managing Director of CLF Ventures and Charles Geraci, PhD, CIH, Coordinator of the Nanotechnology Program at the US National Institute of Occupational Safety & Health (NIOSH). Given the content of our prepared remarks the three of us decided we had been placed in the agenda in the wrong order and staged a soft coup the morning of the meeting, rearranging ourselves in a more sensible order. Questions were held until the end of our talks.
Thus it was that Jo Anne started off the session with a nice overview of nanotechnology and the attendant issues that complicate an assessment of its health and safety impacts. She outlined her approach to risk assessment of nanomaterials, presented in more detail in her new book, “Nanotechnology: health and environmental risks.”
Chuck Geraci was up next, giving a thorough account of NIOSH’s many activities in nanotechnology. He spent some time describing a simple framework for identifying occupational safety issues, summarizing some of NIOSH’s recent toxicological research, including recent work presented at the SOT meeting showing long-straight multi-walled carbon nanotubes penetrating the pleural lining (AKA “The Image”). NIOSH commentary on this work can be found at the NIOSH blog. He ended by plugging the updated guidance document along with a recent document on medical surveillance programs, both available at the NIOSH nanotechnology page.
Faced with a room full of EHS Directors gathered to hear the latest about nanotechnology, what else could I do but talk at some length about the GoodNanoGuide? I gave my pitch, walked through a brief live demo of the site and invited them to participate.
For once, the schedule was constructed to allow for a generous Q&A session, even considering that collectively we went over our allotted speaking time. (In too many of these meetings, “panel” equates to “speakers talking too long leaving audience little to no time for questions.” The ABA CLE was like this.) And this audience availed itself of every minute. Among the discussion threads we pursued were
- The state of knowledge of occupational practices as they relate to medical applications of nanotechnology [a natural for this audience]
- Whether control banding should be applied to nanomaterials and which form might be best
- How to get wayward academics to understand and enforce good occupational practices in their labs [lots of grumbling about the tyranny of the academic overlords (PhD faculty) who fail to appreciate the humble servants that are only trying to help them (EHS managers).]
- Whether biosafety protocols should be in place for labs working with nanomaterials. [Setting up a Level 1-4 type of containment system similar to that used by labs working with known or potential pathogens.]
This last question caught the three of us somewhat flat-footed. It is not a concept I have heard discussed in many other forums on nano-safety. I suppose EHS managers who deal with medical research think more about biosafety than many others in the nanotechnology community who have more of a chemical safety mindset. The question is whether the biosafety approach can be justified, and for which types of nano research. One obvious difference between current nanomaterials and, say, the Ebola virus, is that today’s nanomaterials are still largely the Phase 1 “passive” materials presented in Mike Roco’s much disseminated scheme. Until we progress to the later stages of nanotechnology we should not be overly concerned with nanoparticles multiplying.
Response to our session was very positive and I expect to hear from many of these people again as we all grapple with the occupational issues surrounding academic nanotechnology research. Plus, Janelia Farm is a very cool place to visit.
I was joined on the panel by Stephen B. Ruddy, PhD of Elan Drug Technologies, George Kimbrell, staff attorney of the International Center for Technology Assessment, and Fionna Mowat, PhD of Exponent. Panel organizer Judi Abbott Curry of Harris Beach, LLC, opened with some brief remarks about nanotechnology and its potential importance to the tort law community.
Dr. Ruddy gave his perspective on the broad diversity of nano-based medicines currently on the market or under development, arguing against a “one-size-fits-all” approach to regulation. Elan has launched four nanotechnology based drug products in the US since 2001. He asserted that FDA’s regulatory review process for new drug products appears adequate for nanotechnology-based drug products such as liposomes, nano emulsions and engineered drug nanoparticles but may need to be evaluated periodically as more complex drug products emerge.
George Kimbrell struck a strongly precautionary tone, which should come as no surprise to people familiar with CTA’s work in nanotechnology. [They have filed a number of petitions to FDA and EPA urging them to interpret their regulatory authority more broadly.] He highlighted nanosilver and nanoscale sunscreen ingredients as products of particular concern and called for more federal funding for environmental, health and safety (EHS) research, faster response by federal agencies charged with regulatory oversight, and a stronger regulatory framework that protects workers, the general public and the environment from the impacts of nanomaterials throughout their lifecycle.
Fionna Mowat, an expert in exposure assessment, presented a case study comparing carbon nanotubes and asbestos. Tort lawyers in particular understand the implications of a material showing asbestos-like behaviors. She reviewed three recent papers comparing multi-walled carbon nanotubes (MWCNTs) to asbestos, two of which were reviewed in an ICON backgrounder published last year.The third paper, published this year, investigated the effect of injecting MWCNTs intrascrotally into rats. After identifying similarities and differences between MWCNTs and asbestos fibers she argued for more research and a more nuanced understanding of the potential exposures to MWCNTs throughout the lifecycle.
I spoke last, focusing my remarks on the information needs assessment workshops ICON has convened over the last two years. I previewed some of the conclusions and recommendations of our most recent workshop on Eco-Responsible Design and Disposal of Engineered Nanomaterials, held in Houston in March 2009. One of the working groups focused their attention on regulatory issues for nanomaterial disposal raising questions about whether nanomaterials can leak out of landfill liners, calling for more research into potential impacts of antimicrobial nanoparticles on waste treatment plants, and policies for dealing with nanomaterials in construction and demolition materials, which are often recycled. More information about the workshop’s conclusions and recommendations is forthcoming when the full report is published. Meanwhile, for those who can't wait another moment, Chemical & Engineering News, who embedded a reporter in the two-day workshop, published a summary of views presented and conclusions drawn.
Despite the lower-than-normal level of attendance (blamed on the economy) the question and answer period was lively and it was clear that this was many people’s first serious introduction to the subject of nanotechnology. It is no exaggeration to say that our panel, with its diversity of viewpoints was an eye-opener for attorneys who represent plaintiffs and defendants alike. Afterwards, Ms. Curry confirmed that the tort community is behind the knowledge curve on nanotechnology and that our session accomplished her goal of beginning to inform them about this emerging topic.