University of California, San Francisco Publishes Draft Nanotechnology Regulatory Policy Recommendations.
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:
- Develop a description of nanomaterials that can be used to identify them.
- Identify and define priority properties which could be used in risk characterization and collect these properties for each nanomaterial, including: "traditional" risk assessment or hazard identification properties, such as molecular formula, density, solubility, vapor pressure, melting point, etc. as applicable; "unique” nanomaterial-specific properties, such as size, shape, surface functionality, charge, stability, and reactivity.
- Develop characteristics by which to define, describe, and group nanomaterials according to conventional or unique properties.
- Gather information regarding what types of nanomaterials are being manufactured and in what products they are being used.
- Support a publicly accessible clearing house and inventory of products and sources of nanomaterials. Require disclosure of where nanomaterials are manufactured, in what quantities and for what new or existing products such as through product labeling.
- Collect information on fate and transport of nanomaterials, including monitoring in environmental and biological media. Require centralized reporting mechanisms, and maintain them in a systematic manner (could be incorporated into clearinghouse in recommendation 5 above).
- Develop a framework for making policy and regulatory decisions based on nanomaterials’ use, exposure potential, and exposure to susceptible subpopulations, while weighing public health or societal benefit.
- Require testing of release and exposure potential for nanomaterials in consumer products that have widespread use, such as titanium dioxide, silver nanoparticles and carbon nanotubes. Testing must be completed for products to remain on the market.
- Integrate nanomaterial safe handling practices into standard lab safety training for academic, industrial and other laboratory workers and students.
- Use existing hazard traits from other chemicals and toxicological and environmental health-related endpoints to assess potential adverse health outcomes from nanomaterial exposure.
- Risk assessment guidelines should be evaluated to determine whether they sufficiently cover nanomaterials and if found to be lacking, adjust or incorporate accordingly to include them in decisions. Use existing data to evaluate and consider applying an adjustment factor to address enhanced risk for those nanomaterials that exhibit certain properties such as charge, certain size and certain surface functionalities.
- Targeted research in the area of biological transport and distribution of nanomaterials including sources, routes of contact, and internal distributions. Integrate this with the information gathered on exposure potential.
- Develop and maintain relationship with other governments (i.e. EU, Canada) and researchers (i.e. California NanoSystems Institute at University of California, Los Angeles) who conduct the research, to share relevant data and information.
- Require sufficient toxicological testing information to assess safety of risks to consumers, including susceptible subpopulations such as infants preferable premarket, and post-market as necessary.
- Implement a labeling system that requires labeling products that contain nanomaterials. Evaluate nanomaterials to determine if any should be placed on Prop 65 list.
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.
- A Nanotechnology Policy Framework: Policy Recommendations for Addressing Potential Health Risks from Nanomaterials in California, http://prhe.ucsf.edu/prhe/nanoreportDRAFT.pdf (last visited Apr. 29, 2010).
- Approaches to Safe Nanotechnology: Managing the Health and Safety Concerns Associated with Engineered Nanomaterials, http://www.cdc.gov/niosh/docs/2009-125/pdfs/2009-125.pdf (last visited Apr. 29, 2010).
- Department of Energy, Nanoscale Science Research Centers, Approach to Nanomaterial ES&H, http://orise.orau.gov/ihos/nanotechnology/files/NSRCMay12.pdf (last visited Apr. 29, 2010).
- The International Council on Nanotechnology, Virtual Journal of Nanotechnology Environment, Health and Safety, http://icon.rice.edu/virtualjournal.cfm (last visited Apr. 29, 2010).
- OECD Database on Research into Safety of Manufactured Nanomaterials, http://webnet.oecd.org/NanoMaterials/Pagelet/Front/Default.aspx? (last visited Apr. 29, 2010).
- PRHE Announcement, http://prhe.ucsf.edu/prhe/nanoannouncement.pdf (last visited Apr. 29, 2010).
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