A successful international joint regulatory meeting was held in Washington, DC on March 10 and 11 drawing upon the collective knowledge of more than 150 government regulators, consumer advocates, and interested private sector representatives. The meeting, titled “Bridging NanoEHS Research Efforts: A Joint US-EU Workshop,” was intended to “provide an open forum and engage in an active scientific discussion about environmental health and safety questions for nanomaterials and nanotechnology-enabled products, to encourage joint US-EU programs of work that would leverage resources, and to establish communities of research practice, including identification of key points of contact/interest groups/themes between key US and EU researchers for near-term and future collaboration.” Dr. Anna Gergely from Steptoe & Johnson LLP was an invited participant to the meeting and she contributed her knowledge, experience, and insight into these discussions.
The workshop agenda featured examples of both EU and US efforts, and highlighted “environmental health and safety” (EHS) research programs and related initiatives, and included industry and non-governmental organization (NGO) perspectives on these research efforts. Several themes came up repeatedly across the two days of discussion, particularly in the March 10 breakout sessions which were designed to focus on and explore human health and environmental data needs for nanomaterials. During the second day (March 11), detailed breakout sessions covered:
- characterizing the intrinsic hazard characteristics of nanomaterials and how surface modification to nanomaterials can change these properties;
- understanding the most relevant and accurate measures of toxicity and exposure and whether new methods are needed to apply this understanding to establish protective exposure limits based on health effects;
- identifying the critical factors driving fate and transport in the environment as well as exposures among consumers and the population at large; and
- evaluating existing “model nanoparticles” (i.e., nano reference materials such as those being established by an EU initiative) to determine if they can be used to assess worker exposures and identify protective industrial hygiene practices.
The repeated themes that came up during discussions were by-and-large not “new” concerns or thoughts, and often centered around existing uncertainties regarding the ability to measure nanomaterials in the workplace and how to design conservative hygiene programs in the face of incomplete information. For example, a US Environmental Protection Agency (EPA) representative lamented that regulators do not have enough information on exposure point concentrations mainly due to lack of methods to measure nanoparticles in various matrices, such as soil, air, water, blood, and urine. It should be noted that this state of knowledge should change in the near-term as the ongoing California Department of Toxic Substance Control (DTSC) “chemical call in” for metal oxides, carbon nanotubes, and quantum dots has requested detailed information along these lines, which will be shared with EPA and other California regulatory agencies through a series of information-sharing agreements (see our earlier column on California’s nanomaterial DCI). Through its data call in, DTSC is asking for analytical approaches for “identifying and determining concentration of nano chemical, its metabolites, and degradation products in specified matrices,” including water, air, soil, sediment, sludge, chemical waste, fish, blood, adipose tissue, and urine.
Much discussion during the workshop also centered around the effectiveness of existing industrial hygiene workplace controls and related regulations. While a US industry representative stated that workers are already adequately protected by a number of different regulations that apply to chemicals, European regulators countered that not only do “we know almost nothing” about worker exposures but little is known about what nanomaterials are released in workplace environments, the rates at which they are released, and what constitutes the most sensitive receptor and toxic endpoint. Towards this end, conference participants suggested leveraging existing applicable data and other information on how to control worker exposure to ultrafine particles. Such a project has been underway in Europe since 2009—the “Nanodevice Project”—which is striving to design workplace monitoring devices (for nanoscale materials) affordable to smaller companies.
Finally, several participants issued a strong call for a more comprehensive and focused approach to management and curation of nanomaterial-specific data. It has long been recognized that a “publication bias” exists against negative findings, such that typically only positive findings (e.g., a nanomaterial toxicity study shows adverse health effects) are submitted for publication, despite the fact that negative studies can provide just as much insight into health effects and toxic mode of action. At the meeting, there was a strong sentiment that journals should not only accept negative studies for publication, but should institute a peer review system for all submitted nanomaterial data, positive or negative. Furthermore, to facilitate future international harmonization of the overall nanomaterials knowledgebase, it was suggested by participants that existing databases be coordinated and/or linked together to promote information sharing and greater global understanding of the risks nanomaterials may pose to human health and the environment.
While the joint EU-US meeting may not have addressed all of the pressing questions of the day with regard to understanding EHS impacts from nanomaterial use and production, it was enormously successful in terms of setting the stage for future international collaborations in this area. Materials from the meeting are expected to be posted to http://www.nano.gov/ in the coming weeks as the conference organizers, as of this writing, are still compiling breakout session summaries and speaker presentations for public posting.