>> Treye Thomas: Thank you all for joining us today. My name is Treye Thomas, and on behalf of the NEHI Working Group I would like to welcome you to the webinar. The NEHI Working Group is composed of a number of representatives from Federal agencies, and focuses on the support of the responsible development of nanotechnology. So it's really important for us to reach out to our stakeholdersandprovideusefulinformationonanumberoftopics supporting nano[technology-related] environmental, health, and safety [issues]. We're very pleased to have this webinar and pleased that you could join us, and since we have a very short amount of time, I would like to turn it over to Dr. Ajit Jillavenkatesa who will serve as our host for the webinar today. ThankyouandIwillturnitovertoAjit. >> Ajit Jillavenkatesa: Thank you very much for that introduction and certainly my thanks to the participants who are taking time out of their schedule to join the conversation. So [for] those of us participating in the panel, it's pretty clear we like standards. We really like standards. That's why we're in the midst of it, but we also appreciate our participants joining in. Good morning to everyone, and good afternoon particularly to our international colleagueswhoarealsojoiningfromdifferentpartsoftheworld. 1 >> Ajit Jillavenkatesa: So this is a great opportunity to start talking about some fundamental aspects around standards, and particularly exploring aspects of standards with regards to NanoEHSandwhythey'reimportant. We have a great panel representing three different perspectives. Dr. Shaun Clancy is a director of product stewardship at Evonik Corporation. Shaun is very active in a range of international, multilateral activities, and will provide industry perspectives. Following Shaun we have Dr.Stacey Harper,anassociate professor at Oregon State University. Stacey is also the chair of [ASTM] Committee E56 [on Nanotechnology], and brings a lot of good perspectives. And the last speaker this morning is Dr. Anil Patri, who is with the U.S. Food and Drug Administration. Prior to joining the FDA, Dr. Patri was a staff member and a leader at the National Cancer Institute’s Nanotechnology Characterization Laboratory. So he brings really unique perspectives both from a practitioner’s side and also from a standards development side, and now particularly fromaU.S.FederalGovernmentagencythathasanimportantrole intheregulatorycontext. 2 >>AjitJillavenkatesa:Sowithoutmuchado,whatIwantedtodois very quickly is to talk a little bit about some baseline issues. First and foremost is the concept of what is a standard? Colloquially, weusethistomeandifferentthings.Itcanbeaprotocol.It'soften used to describe a kind of a very generally agreed-upon measurement method, because it's been used many times and fairly often, but it can also refer in this context or in an NPL [National Physical Laboratory of England] English context to a physicalstandard,thebasisorthebaseunitsformeasurement. As many of you are familiar, standards also refer to well-characterized materials, but for the purposes of our discussion and the conversation here, what we're talking about is adocumentary standard.Thisisalsoknownasvoluntarystandard, consensus standard. These are products, which are typically defined or developed by a range of experts who represent different perspectives. They could be representing their individual perspectives or their organizations, coming together in a very well-run moderated forum, and through a very transparent and predictable and iterative process, they develop an agreed-upon wayofdoingthings,whichoftenrepresentsthestateoftheart 3 >> Ajit Jillavenkatesa: A light-hearted look at why standards matter.Ithinkallofusknow standardsareimportant,theymatter. But the reason why also, from our perspective, standards really matteris[that]standardsdoabunchofthings. 4 >>AjitJillavenkatesa:Firstofall,theyactuallyenableustodevelopa sharedvocabulary.WhenIuseaparticularphrase ora word,howdo I have assurance that what I'm trying to convey is exactly the same that you will understand, you will think of? Where this becomes particularly important is certainly in sharing of information, but also often in aspects of trade or in aspects of commerce, where words canhavesignificantimplications. As many of you are aware, and certainly of big interest for you, is the fact that standards enable the protection of health, safety, and [the] environment. But also because standards and the standards development processes bring together a range of experts from a range of different industries, from a range of different academic institutions, bodies. And these are people who are experts in that particular area, in that field. It reflects the state of technology, the stateofart. 5 >> Ajit Jillavenkatesa: There is always a push for developing consensus, and in that manner, what standards do is they embody, really broad agreement about ways of doing things. By doing that, it creates the foundation for technological innovation. What this really means is that companies can use a standard as the basis for developing their product, their service, their system, which actually helps them save money,because of this foundationupon which they can build. And in areas like manufacturing, whatstandards enable us to do is develop economies of scale. We're not having to develop different products or different markets or different approaches for different markets. We can use the same standards as the basis for thendevelopingdifferentiatedorvalue-addedproducts. 6 >> Ajit Jillavenkatesa: So it should not be at all surprising that standards have a really broad impact. They enable trade and certainly play a major role in enabling technology and innovation, but they also facilitate competitiveness. And so standards are more than just technical instruments. They really have economic, social,geopoliticalaspectstoo. 7 >> Ajit Jillavenkatesa: In the context of nanotechnology standardization, the formal international standards development activities in bodies such as ASTM, ISO, and the IEC [International Electrotechnical Commission] started right around the 2004-2005 time frame. So we're almost approaching -- just past about the ten-yearpoint.Andwhatwe'restartingtoseeisacertainmaturity andcertainmaturationofthestandardsdevelopmentprocess. Different bodies have taken slightly different approaches, and not surprisingly, while initially there's a slight shake-out period as different groups are trying to identify their scope of activities, we'renowatthestagewhereinternationalstandardsactivitiesfor nanotechnology have really started to develop some very good aspects. There is incredibly strong industry participation. It's very international inits nature.We're starting to see uptake of many of thesestandards,thenanotechnologystandards, certainlyamongst industry,butalsoamongstmanyregulatorswhoareactuallytrying to reach out to really broad regulated communities. And these standards are starting to address some very fundamental questions around measurements, around EHS aspects. So this is reallysettingthestageforasolidbodyofwork. 8 >> Ajit Jillavenkatesa: Over this ten-year period what they're starting to see is a broad grouping of how standardization is startingtocometogether.Thisfocusondevelopingterminologyor nomenclature (what do you call something); how do you measure it (which is the measurement of the characterization aspect); the EHS aspects (what effect it may have on health, safety, and the environment); how do we categorize, how do we classify materials; often on specifications (this is a recognition of the fact that nanotechnology also is reaching a certain maturity in commercialization,andsoasitentersintomainstreamcommerce, how should materials be specified in a supply chain or in a value chain?). We'restartingtoaddressthe question ofimpacts andimplications through societal issues, through consumer and sustainability aspects, and increasingly as we're starting to see, again, from a commercialization perspective, both nanotechnology-enabled and nanotechnology-enhanced products, we’re now starting to see a desire for standardization that helps address some fundamental questions around devices or around systems. So we're going past justthematerialscharacterization,butthatisnottosaythereisn't strong interest in further exploring issues around materials characterization, like there is a lot of interest around graphene standardization. 9 >> Ajit Jillavenkatesa:SoIthinkcertainlyoneofthethingsthatwe see as a broad trend, is a focus not only on addressing technical issues, but also on broader issues, which go beyond just the technical issues. And I think this is a really good sign that standardization is not just applicable only to a few select experts working within technical companies, but is also really resonating withpeopleatlarge. 10