The new 2011 edition of Nanotechnology Law published by West/Thomson/Reuters is now out. I update the book every year and the new edition has lots of new stuff. They make excellent Christmas and Birthday gifts, and are a general cure for insomnia. All proceeds go to my underprivileged daughters' college fund. Everyone should have one (or two).
One June 9, the President's Office of Budget and Management, United States Trade Representative, and Office of Science and Technology Policy issued a joint memorandum directed to all Executive branch departments and agencies entitled "Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications ofNanotechnology and Nanomaterials."
The Policy Statement is important because it confirms a "best-science" approach to potential nano-EHS issues, rather than a reactionary approach. While this has been the stated approach of various federal agencies in the past, it is nice to see it reaffirmed across the entire federal government at the highest levels. The memorandum also reaffirms the importance of nanotechnology to the US economy, and recognizes the potential adverse economic consequences that knee-jerk regulation might have.
Perhaps most interesting is that the memorandum repeatedly refers to the sufficiency of existing regulations to deal with potential nano-related EHS risks. Some advocacy groups may have been holding out hope that the Obama administration would enact new nano-specific regulations. That is very doubtful given the tenor of the memorandum, which should provide industry with a measure of reassurance in this regard.
This article originally appeared on the National Nanomanufacturing Network's InterNano website on April 30, 2010. It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.
The Program on Reproductive Health and the Environment (PRHE) at the University of California, San Francisco (UCSF) is part of the Department of Obstetrics, Gynecology & Reproductive Services located in UCSF’s School of Medicine. PRHE recently published its draft “A Nanotechnology Policy Framework: Policy Recommendations for Addressing Potential Health Risks from Nanomaterials in California.1” The draft nanotechnology policy framework will be presented to Cal/EPA’s Office of Environmental Health Hazard Assessment once finalized to “better inform . . . risk assessment recommendations for decision makers and risk managers.” It was designed to provide the State “with an overview of nanotechnology materials and their potential exposures and human health risks, and proposes a selection of policy options for addressing potential hazards and risks from nanotechnology.”
For those who might wonder about PRHE’s focus, its “mission is to create a healthier environment for human reproduction and development through advancing scientific inquiry, clinical care and health policies that prevent exposures to harmful chemicals in our environment.” While its draft nanotechnology policy framework briefly touches upon reproductive issues, it provides a more general approach to what its authors see as difficulties presented by the potential regulation of nanotechnology (or lack thereof) in California.
The draft nanotechnology policy framework was written by three PRHE staff members with the assistance of an eleven member scientific advisory panel. Only one business – DuPont – had a representative on the scientific advisory panel, and there were no representatives from the federal government (FDA, EPA, NIOSH or otherwise). In fact, federal efforts to deal with nano-related environmental, health, and safety issues are summarily dismissed: “In light of the NRC’s analysis that the federal government is inadequately prepared to deal with strategic nanotechnology risk research, and given the current changing field of chemicals policy in California, it is an appropriate time to consider new ways of regulation in the area of nanotechnology.”
The first three chapters of PRHE’s draft nanotechnology policy framework provide a general introduction to nanotechnology including an overview of some of the science regarding nano-material toxicology; potential for exposure and assessing the alleged risks of nanotechnology; and fate, transport, and transformation of nanoscale materials in the environment and biological systems. It also contains several “case studies” covering previous chemical substances which PRHE believes may have been mishandled, and thus could provide some insight to California regulators regarding how to address some of the uncertainties presented by certain nanoscale materials. The overview provided by these chapters is unbalanced and somewhat skewed, but the general themes have been covered in depth by several other organizations. At the very least, these chapters of the draft nanotechnology policy framework show that PRHE is truly attempting to understand these complex issues.
Fifteen Policy Recommendations
For our readers, the most interesting part of the draft nanotechnology policy framework will likely be its fifteen specific policy recommendations appearing in Chapter 4:
Should California Reinvent the Wheel?
Several of these recommendations have been voiced by other groups including the federal government, ISO, OECD, etc. PRHE’s draft nanotechnology policy framework could benefit from a detailed analysis of the effectiveness of existing programs already in place in the US and globally to achieve many of the recommendations urged by the authors. It is difficult to imagine that California has the desire (or funds) to replicate the same research being undertaken by hundreds of top researchers already in the field.
For example, should California develop its own definition of “nanomaterials,” or is it better and more effective to rely upon definitions promulgated by standard setting bodies such as ASTM, ANSI, and ISO? Similarly, these bodies are already developing methods to determine the “characteristics by which to define, describe, and group nanomaterials according to conventional or unique properties.” Should California join their efforts, or pursue its own independent path?
As another example, should California come up with its own policy and guidelines to “integrate nanomaterial safe handling practices into standard lab safety training for academic, industrial and other laboratory workers and students,” or should it defer to NIOSH’s excellent existing guidelines on this issue?2 - or even the Department of Energy’s?3
As a third example, there is already a large amount of research ongoing regarding the “biological transport and distribution of nanomaterials including sources, routes of contact, and internal distributions.” One need only search the International Council on Nanotechnology’s Virtual Journal of Nanotechnology Environment, Health and Safety4 to see what has already been published on these issues. OECD also has a nice online database covering these areas.5 Should California reinvent the wheel in this regard?
Perhaps the answer to all of the above-questions is “Yes.” Maybe California should undertake all of these efforts because they are not being effectively addressed by others. However, before making such recommendations the authors should at least evaluate and critique ongoing efforts in these areas so California’s policy makers can better prioritize their efforts.
Disconnect Between Science, Existing Regulation, and Policy Recommendations
Another major issue with PRHE’s draft nanotechnology policy framework is the disconnect between the science overview set forth in its first three chapters and the 15 policy recommendations appearing in its fourth chapter. It would be interesting for PRHE to develop the linkage, if any, between what it sees as the main gaps or deficiencies in the existing science and regulation surrounding nanoscale materials and PRHE’s specific policy recommendations. Simply put, how do PRHE’s 15 specific policy recommendations works towards solving the problems it identifies? Of course, the document is only a draft and perhaps PRHE will address these issues in its final version.
Two Most Controversial Recommendations
Perhaps the two most controversial recommendations in PRHE’s draft nanotechnology policy framework are its proposals to require pre-market testing for consumer products containing nanoscale materials and the mandatory labeling of such products. Both approaches have been considered and rejected (for the time being) by the federal government. Unfortunately, little effort is taken to develop the factual, logical, scientific, or legal support for these recommendations. This is particularly frustrating because the two major groups of effected stakeholders -- consumers and consumer product manufacturers/distributors -- appear to have had little, if any, input into the draft nanotechnology policy framework. However, quite a bit has already been written on these subjects, and authors have plenty of source material to assist in their analysis before the draft is finalized.
Public Comments and Meeting
PRHE has invited public comments regarding the draft nanotechnology policy framework and is holding a conference on May 5, 2010 which will include presentations from the science advisory panel who worked on the document, as well as time for public comment.6 Given the scope of the report, it will be interesting to see what comments and analysis can be pulled together by interested stakeholders in the relatively short time allotted by PRHE for review.
References
This article originally appeared on the National Nanomanufacturing Network's InterNano website earlier today. It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.
Maxine Savitz[1] and Ed Penhoe[2] provided a recent presentation summarizing the highlights of the President’s Council of Advisors on Science and Technology (PCAST)[3] report on the status of the US National Nanotechnology Initiative (NNI) at a public meeting held at the National Academics on March 12, 2010.
Ms. Savitz provided a brief review at the beginning of the presentation regarding how, when, and why NNI was formed; its history from 2000 - 2010; and some of the participants in the PCAST review process. Participants included representatives from DuPont, IBM, A123 Systems, Nanocomp Technologies, Rice, Harvard, Caltech, Sandia National Labs, and the Woodrow Wilson Institute. Ms Savitz also explained that the group held two prior working meetings to solicit input from government agencies, the legislative and executive branches, as well as outside stakeholders. Finally, she explained that PCAST’s report has three major thematic areas: NNI program management; NNI output and work product; and NNI environmental, health, and safety programs and strategies.
Ed Penhoet then provided an update regarding NNI’s continued successes. He noted that the US is currently the world leader in nanotechnology and commercialization, but that other nations are gaining fast -- particularly in Asia and Europe. He further noted that NNI has had a substantial impact on the US nanotechnology industry over the past ten years, which can be seen in the larger number of nanotechnology patents filed, nano-related publications, and nano-related products hitting the commercial market during that period.
Mr. Penhoet further explained that while NNI is being effectively managed, there is still room for some improvement and greater coordination.
For an example, Mr. Penhoet pointed out that there is a lack of basic underlying data from which to analyze the economics of nano-related research, development, and commercialization in the US. Thus, it is difficult to precisely quantify the economic effectiveness of the NNI in measurable terms.
As another example, Mr. Penhoet also mentioned the need to identify and understand potential nano-related risks -- both for purposes of fundamental science, and also to provide a clear regulatory environment and path for commercialization. While undoubtedly a significant portion of PCAST’s written report touches on these issues, the topic was only briefly mentioned in passing during the presentation.
Mr. Penhoet then spent the majority of his presentation explaining the five major recommendations embodied in PCAST’s written report:
The presentation closed with comments by several PCAST members regarding (i) potential methods for developing the underlying economic data needed to properly evaluate nano-related job creation and return on investment; and (ii) potential methods for increasing retention rates of foreign students obtaining advanced nano-related degrees in the US by reducing and/or streamlining citizenship restrictions.
PCAST voted to accept and approve the report after it is amended to reflect the comments discussed during the presentation.
References
[1] Director of the Washington Advisory Group, an LECG Company. Ms. Savitz is the former Deputy Assistant Secretary for Conservation, US Department of Energy. Prior to her DOE service, she was program manager for Research Applied to National Needs at the National Science Foundation. Following her government service, she served in executive positions in the private sector, including: President of Lighting Research Institute, assistant to the vice president for engineering at The Garrett Corporation, and General Manager of Allied Signal Ceramic Components. She recently retired from the position of General Manager for Technology Partnerships at Honeywell.
[2]President of the Gordon and Betty Moore Foundation. Mr. Penhoet is the former dean of the School of Public Health at the University of California, Berkeley, prior to which he cofounded and managed the Chiron Corporation. Prior that he was a faculty member of the Biochemistry Department of U.C. Berkeley. Mr. Penhot currently serves as the vice chairman of the Independent Citizen’s Oversight Committee which oversees the California Institute for Regenerative Medicine created by the passage of Proposition 71, the stem cell initiative.
[3] http://www.whitehouse.gov/administration/eop/ostp/pcast.
FDA Week is reporting that a meeting at the Food and Drug Administration late last month failed to result in any agreement about a possible policy on nanomaterials. The FDA Nanotechnology task force met on July 22, 2008 to consider the creation of a policy for nanomaterials, but failed to come to any consensus on whether one should be drafted, let alone the contents.
The primary disagreement appears to be whether to issue a policy at all, or rely on existing statutory and regulatory controls. As one might expect, the panel was split on this issue, resulting in no action in the short term. The split was right down the middle with 5 panel members voting in favor of a policy, 5 voting against, and 1 abstaining.
The panel did agree that FDA should collaborate with OSHA and EPA should either agency begin drafting a policy concerning nanoparticles. FDA will hold a public meeting in September to discuss particle size in drugs and how to obtain such information from its current database.
FDA's inaction is not wholly surprising given the state of nanotechnology regulation. However, the even split was somewhat unexpected. The debate seems to center around the data submissions by companies seek FDA approval on products and what is already required. I, personally, would not have thought the division would be so even (unless purposefully manufactured). Perhaps this is a mircochasm of the public generally, that being a 50/50 split on what the next step should be? Or perhaps this is administrative gridlock in an election year? Or perhaps this is simply an administrative agency continuing to act deliberately in considering the nanotechnology question?
The report, available on the Institute's website, lists twelve policy considerations that it believes should be considered as a policy framework is developed. Those policy considerations are: 1) societal goals, 2) public education and engagement, 3) activity and information inventories, 4) identification of lead agencies, 5) technical issue identification such as terminology and metrology, 6) regulatory framework priority identification including risk assessment, science, and stakeholder involvement, 7) labeling and consumer protection, 8) liability and intellectual property issues, 9) support for science and research, 10) commercialization and economic benefits, 11) training, and 12) security.
The report delves into each consideration in more detail, but the Institute believes that each should be developed in order to establish a solid nanotechnology framework in Canada.
Interestingly, the report also touches on barriers to a national nanotechnology policy in Canada, many of which are the same as those facing the United States. The report cites such policy development challenges as the lack of information and lack of tools to "deal responsibly" with nanomaterials already in commerce. The needed tools the Institute points to include: standard definitions, labels, and data sheets, as well as "structures and resources for public education and engagement." These are some of the very challenges facing policy development in the United States.
Through consideration of the twelve points above, the Institute believes that Canada can begin to create a policy framework. The Institute states that at this early stage, "our proposed policy framework focuses on goals; on what needs to be attended to; and to a lesser extent how it should be done: the elements of a policy framework."
Clearly nanotechnology policy development is an international issue, with many, if not all, of the same challenges and questions arising for each country to delve into the regulatory questions surrounding nanotechnology.
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