University of California, San Francisco Publishes 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 just published its "Recommendations for Addressing Potential Health Risks from Nanomaterials in California” which was commissioned by California's Office of Environmental Health Hazard Assessment  (OEHA).  The document is 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.  We previously provided our comments on the May 2010 draft of this document here.  A year later, many of our same concerns still apply to the final document.

The new document makes a range of recommendations, which are set forth below:

Recommendations to address health risks from nanomaterials for OEHHA that can be achieved under the existing regulatory structure:

1. Develop a definition of nanomaterials that can be used to identify them.

2. Identify and define priority properties for risk characterization and collect information about them for each nanomaterial.

3. Develop characteristics by which to define, describe, and group nanomaterials according to conventional or unique properties.

4. Establish a publicly accessible clearinghouse and inventory of nanomaterial sources and products.

5. Identify and/or develop methods for monitoring nanomaterials in environmental media and through human biomonitoring.

6. Collect information on the fate and transport of nanomaterials, including through monitoring in environmental and biological media.

7. As for other chemicals, focus on identifying and addressing nanomaterials that are persistent, bioaccumulative, and toxic (PBT).

8. Use existing hazard traits from other chemicals and toxicological and environmental-health-related endpoints to assess potential adverse health outcomes from nanomaterial exposure.

9. Evaluate existing risk-assessment guidelines to determine whether they sufficiently cover nanomaterials, adjusting or incorporating nano-specific approaches as needed.

10. Integrate nanomaterials into current efforts to modernize toxicity testing.

11. Develop and maintain relationships with other governments and researchers to share relevant data and information on nanotechnology and nanomaterials’ use, applications, and toxicity.

12. Improve coordination and monitor communication among federal and state agencies, other countries’ governments, businesses, and NGOs.

13. Continue to include opportunities for public input and comment during decision-making processes.
 

Recommendations to support successful approaches to address potential health risks from nanomaterials that are currently outside the scope of OEHHA.

1. Require disclosure of where and what nanomaterials are manufactured, in what quantities, and for what new or existing products.


2. Require reporting of properties that can identify nanomaterials that are persistent,bioaccumulative, and toxic (PBT). Phase out uses consistent with approaches for other PBTs.


3. Develop a framework for making policy and regulatory decisions that balances the uses and benefits of nanomaterials with their toxicity and exposure potential.


4. Require testing of release and exposure potential for nanomaterials in consumer products for both existing and new products.


5. Increase efforts to protect and educate workers, researchers, and downstream users of nanomaterials


6. Require sufficient toxicological testing—preferably pre-market and also post-market as necessary—to assess risks to manufacturing and other workers and to downstream users, including consumers and susceptible subpopulations such as infants.


7. Implement a labeling system that requires labeling of products that contain nanomaterials.
 

8. Increase funding and support for targeted, nano-specific research to fill data gaps.
 

9. Conduct targeted research on the biological fate, transport, and distribution of nanomaterials, including sources, exposure routes, and internal distributions. Integrate this research with information gathered on exposure potential.
 

California Targets Nanoscale Metal Oxides and Quantum Dots for Data Call Ins

California's Department of Toxic Substances Control (CDTSC) held a conference today during which they identified the next six nanoscale materials they intend to target in their second round of data call ins.  Regular readers may remember that CDTSC targeted 26 manufacturers/importers of carbon nanotubes with its first data call in in 2009. 

In addition to identifying the nanoscale materials which will be the subject of the data call in, CDTSC also provided a preliminary list of manufacturers/importers that will receive the data call in, as well as the proposed questions they will be asked.  We cover each material below.

CDTSC also indicated that carbon nanotube manufacturers/importers will receive a second round of data call in questions. 

CDTSC plans to issue all of these new data call ins sometime before the end of the year.  Stay tuned . . .

Nano Silver

Proposed Questions:  What is the chemical composition of your nanosilver material? What is particle size of your nanosilver material used? What is the concentration of nanosilver used in your material? What are the instrumental techniques used to characterize your nanosilver material?What are the analytical methods used in your nanosilver material? How do you measure and monitor fate and transport after useful life of your nanosilver material? How do you detect, measure and monitor releases during facility operations?

Preliminary Recipients:  Nano Composix, Cambrios Technologies, Seashell Technology, Sun Innovations, Stanford Materials, MTI Corporation.

Nano Zero Valent Iron

Proposed Questions:  What are the analytical methods for assessment of toxic effects and safe uses of nano zero valent iron across its lifecycle? How do you sample, measure, and monitor quality? Performance? How do you detect, measure, and monitor releases from facility operations? How do you measure and monitor fate and transport after useful life?

Preliminary Recipients:  American Elements, AMEC Geomatrix, hepure Technologies, OnMaterials, Quantum Sphere, Stanford Materials, Sun Innovations.

Nano Titanium Dioxide

Proposed Questions: What machines and methods do you use to analyze your materials? What are the properties of your materials? After modification? What types of monitoring program are you using in your work place? In air? In water? What is the toxicity when your material is directly contacted with human skin? What is the weathering, liberation rate of your material into the environment? Impacts? What is you actual production amount this year?

Preliminary Recipients:  DuPont, BASF, Evonik, Ishihara, Altair nano, Huntsman, Kronos, Kemira, Kon Corp., Tronox, Nanocompsix, Nano-oxide, Green millenium, MK nano, Advanced Nano, NanoCo, Pilkington.

Nano Zinc Oxide

Proposed Questions:  Describe .specifically the nanostructure, functionalities, and properties (physical, chemical, and biological) of nano zinc oxide material that is produced in the facility.  Describe the in-house instrument and analytical methods you use to determin the presence of nano zinc oxide in the workplace and environment. Describe the chemical information provided by external vendors relative to nano zinc oxide nanostructure, functionalities, and properties.  Describe the instrumentation and analytical methods used by external laboratories that provided the above chemical information.

Preliminary Recipients:  UC San Diego, UC Berkeley, USC, Ferity Zinc Oxide Inc., APF Laboratories, Atomate Corporation, Stanford Materials, Alpha Enivornmental, Nanophase technologies, Sokang nano, Antaria Corporation, Ocean Nano Tech, LaamScience, Advanced nanotechnology, NanoGate, Inframat Advanced Materials, Reade Advanced Materials, KIA, Nanjing Hi Tech Nano Material Co., ltd., Nanozinc Oxide South Africa, NanoMaterials Technology, UmiCore Group, Horsehead Corporation.

Nano Cerium Oxide

Proposed Questions:  What machines and methods do you use to analyze your materials?  What are the properties of your materials? After modification? What types of monitoring program are you using in your work place? In air? In water? Do you know reactions when your material is released into aquatic environment? Do you know reactions when your material is released into air? What is you actual production amount this year?

Preliminary Recipients:  Saint-Gobain, Evonik, Meliorum Tech., Inframat Advanced materials, Antaria, HEFA Rare Earth Canada, Nanocerox, Nyacol, Energenics, MTI Corporation.

Quantum Dots

Proposed Questions:  What are the chemical compositions (purity, concentration, and chemical make-up) of your product's core and shell structures (including organic and inorganic attachments)? Specify its size, hydrodynamic diameter (HD), and surface area.  What analytical detection methods do you use to determine its presence in the workplace and environment? What are the surface properties (surface reactivity, groups, charge) and solubility in water and other solvents? What is the stability of your product in different environments (variable pH, temp, pressure, O2, UV light, water, etc.)? Does it aggregate in aquatic media?

Preliminary Recipients:  Nanosys/QD Soleil, Bloo Solar, Life Technologies, Stio, Quantum Dot Corporation, Chemicon International, Zymera, Invisage Technologies, University of California schools, Intelligent Optical Systems, Kovlo, NanoGram, Philips Lumileds Lighting Co., Toshiba America Electronics Components, Samsung Semiconductor, SEMI, Ultratech, Shrink Nanotechnologies.

 

Nanotechnology VI Symposium: 'Progress in Protection'

Cal. DTSC and UCLA Present -- Nanotechnology VI Symposium: ‘Progress in Protection’

This one-day workshop, on Wednesday, October 13, is sponsored by the California Department of Toxic Substance Control and UCLA. Leading scientists will discuss the latest strategies in protecting workers in the research, development and manufacturing of nanomaterials, and define further research and developmental needs relating to occupational safety and health.

Nanotechnology is an expanding field that has the potential to create many new materials and products with a huge range of applications. It is already being used in cell phones, stain-resistant clothes, cosmetics, disease detection and in medicine. Business projections suggest that nanotechnology could be a $1 trillion industry in the US by 2015.

Registration for this free conference and webcast is required. 

The program presenters are leaders in university research, manufacturing and industry. They include:

WHO

Maziar Movassaghi, Acting Director, California Department of Toxic Substance Control

Andre Nel, M.D., Ph.D., Chief, Division of NanoMedicine, California NanoSystmes Institute; Director, UC Center for Environmental Implications of Nanotechnology

Mark Methner, Ph.D., CIH, Team Leader NIOSH Nanotechnology Field Research Team

Hilary Godwin, Ph.D. Professor, UCLA School of Public Health - Environmental Health Sciences; Education Director, UC Center for Environmental Implications of Nanotechnology

WHEN

Wednesday, October 13, from 9 a.m. to 5 p.m.

WHERE

UCLA California Nano Systems Institute. 570 Westwood Plaza, Building 114. Los Angeles CA 90095. Parking available on the UCLA campus $10. For more information contact: Teresa Lara, UCLA Luskin Center, tlara@publicaffairs.ucla.edu (310) 267-5435 or Charlotte Fadipe, DTSC, Cfadipe@dtsc.ca.gov (916) 956-2838.
 

Comments Regarding Nanotechnology Provisions in California's Green Chemistry Draft Regulation for Safer Consumer Products

Public comments regarding California's Green Chemistry Draft Regulation for Safer Consumer Products were due last week.  My comment /letter on the nanotechnology provisions contained in the draft regulation is set forth below.  Additionally, you can find a copy of the draft regulation here.

 

July 15, 2010

Heather Jones, MS 22A
California Department of Toxic Substances Control
Office of Legislation & Regulatory Policy
P.O Box 806
Sacramento, CA 95812
Re: Comments regarding draft regulation: Safer Consumer Product Alternatives, Chapter 53 of Division 4.5 of Title 22, California Code of Regulations

Dear Ms. Jones:

Please accept this letter as my personal comments regarding the nanotechnology-related provisions of the above-referenced draft regulation. Many thanks in advance for your consideration of my brief thoughts.

As a general matter, I believe chemical regulations should be drafted to provide the State with all of the power it needs to effectively do its job without unfairly maligning any chemical substance, either directly or by implication. It is a delicate balance that this draft regulation obviously attempts to achieve. I hope that my specific comments further assist in this regard.

Definition of “Chemical:” I do not believe that Part 3 of the definition of “Chemical” on Page 5 of the draft regulation is necessary. As you know, that provision provides an alternative definition of “Chemical” as: “Materials or substances manufactured or engineered at the nanoscale, which contains nanostructures, or is considered to be a nanomaterial.” Simply put, the first two parts of the definition of “Chemical” in their current form are more than broad enough to capture all nanoscale chemical substances. There is no need to single them out in a separate provision. Doing so implies some type of special skepticism or worry which is not necessary to accomplish the purpose or objectives of the draft regulation.

Definition of “Importer:” The definition of “Importer” on Page 7 of the draft regulation should contain a phrase acknowledging that “Importers” are entities physically located or operating in California. Businesses located outside of the State which ship products into the State are covered by the definition of “Make available for use in California” on Page 8. This distinction is important because some out-of-state manufacturers/distributors of carbon nanotubes were considered “importers” under the CDTSC’s January 2009 carbon nanotube data call-in. This issue should be remedied in the proposed regulation.

Definitions of “Nanomaterial,” “Nanoscale,” and “Nanostructure”: The definitions of these three terms on Page 8 of the draft regulation are only necessary if Part 3 of the definition of “Chemical” on Page 5 is retained. Consistent with my above recommendation, I respectfully suggest that they be eliminated along with Part 3 of the definition of “Chemical” which incorporates them by reference. However, in the event these terms are retained, the State should strongly consider changing the definition of “Nanoscale” to follow commonly accepted definitions used throughout the world which rely on a size range of 1 to 100 nanometers. Any deviation from this traditional definition should be thoroughly explained and justified by the State.

If the State is concerned that some companies might claim they are exempt from the regulation because the materials they manufacture are larger than 100 nm and thus are not truly “nanoscale,” the definitions of “Chemical” provided in Parts 1 and 2 on Page 5 are still broad enough to capture these companies’ materials. Additionally, the term “approximately” could be inserted in the definition of “Nanoscale” which would provide CDTSC the latitude it needs to review companies seeking to invoke any arbitrary size limitation. Further, the definitions of “Nanomaterial” and “Nanostructure” on Page 8 of the draft regulation could be amended to include materials made or sold by any company representing that it or its products are “nano,” or nanoenabled, etc. This would further prevent undue reliance on a technical size limitation.

Finally, the terms “nanomaterial,” “nanoscale,” and “nanostructure” are currently the subject of draft technical specifications being prepared by the International Organization for Standardization (ISO) which has 163 country participants. If technical definitions are included in California’s regulation, I believe ISO’s definitions are the best place to start. I am sure that ISO would be happy to provide the State with current drafts of the relevant technical specifications upon request.
Thank you again for taking the time to consider my thoughts. I would be happy to discuss the draft regulation with you or anyone else at any time.

Very truly yours,

John C. Monica, Jr.
JCM:alm
 

University of California, San Francisco Publishes Draft Nanotechnology Regulatory Policy Recommendations

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:

  1. Develop a description of nanomaterials that can be used to identify them.
  2. 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.
  3. Develop characteristics by which to define, describe, and group nanomaterials according to conventional or unique properties.
  4. Gather information regarding what types of nanomaterials are being manufactured and in what products they are being used.
  5. 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.
  6. 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).
  7. 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.
  8. 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.
  9. Integrate nanomaterial safe handling practices into standard lab safety training for academic, industrial and other laboratory workers and students.
  10. Use existing hazard traits from other chemicals and toxicological and environmental health-related endpoints to assess potential adverse health outcomes from nanomaterial exposure.
  11. 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.
  12. 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.
  13. 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.
  14. 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.
  15. 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.

References

  1. 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).
  2. 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).
  3. 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).
  4. The International Council on Nanotechnology, Virtual Journal of Nanotechnology Environment, Health and Safety, http://icon.rice.edu/virtualjournal.cfm (last visited Apr. 29, 2010).
  5. OECD Database on Research into Safety of Manufactured Nanomaterials, http://webnet.oecd.org/NanoMaterials/Pagelet/Front/Default.aspx? (last visited Apr. 29, 2010).
  6. PRHE Announcement, http://prhe.ucsf.edu/prhe/nanoannouncement.pdf (last visited Apr. 29, 2010).

Analysis: "Stanford University Responds to California's DTSC Data Call-In for Carbon Nanotubes"

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. 

In late December 2009, California’s Department of Toxic Substances Control (DTSC) received the first response1 to its January 22, 2009 information request regarding carbon nanotubes2. The original request targeted 26 purported California manufacturers and/or importers of carbon nanotubes3.

It asked for information regarding analytical test methods, environmental fate and transport, and other relevant environmental, health, and safety information. The request was issued by DTSC under authority granted by California's Health and Safety Code 699, Sections 57018-57020. Stanford University was the first entity to respond to the six specific questions contained in DTSC’s request:

1.  What is the value chain for your company? For example, in what products are your carbon nanotubes used by others? In what quantities? Who are your major customers?

2.  What sampling, detection and measurement methods are you using to monitor (detect and measure) the presence of your chemical in the workplace and the environment? Provide a full description of all required sampling, detection, measurement and verification methodologies. Provide full QA/QC protocol.

3.  What is your knowledge about the current and projected presence of your chemical in the environment that results from manufacturing, distribution, use, and end-of-life disposal?

4.  What is your knowledge about the safety of your chemical in terms of occupational safety, public health and the environment?

5.  What methods are you using to protect workers in the research, development and manufacturing environment

6.  When released, does your material constitute a hazardous waste under California Health & Safety Code provisions? Are discarded off-spec materials a hazardous waste? Once discarded are the carbon nanotubes you produce a hazardous waste? What are your waste handling practices for carbon nanotubes?

Stanford’s response was thoughtful, yet very basic. The University confirmed that it follows standard laboratory safety procedures, has implemented most of the nanosafety guidelines issued by the National Institute for Occupational Safety and Health (NIOSH), and that it treats nano-waste as “hazardous waste” for disposal purposes. A summary of Stanford’s answers follows.

In response to DTSC’s first “value chain” question, Stanford responded that it has identified 16 of its laboratories that are working with carbon nanotubes. Research topics include medical applications, electronics, energy storage, fuel production, fundamental physics, and material science research. To support its “value chain” answer, Stanford attached five research papers resulting from its laboratories’ activities.

Regarding DTSC’s second “monitoring” question, Stanford answered that because there are only minimal risks of exposure and release of carbon nanotubes in its laboratories, it has not yet developed or implemented any quantitative sampling or detection methods. The University also advised that it was working with NIOSH to conduct a possible site visit of its facilities in 2010 to potentially address these issues.

Responding to DTSC’s third question concerning the “projected presence” of carbon nanotubes in the environment which may result from Stanford’s activities, the University answered that there could conceivably be (i) accidental releases and spills, (ii) routine releases from laboratory handling, and (iii) the presence of carbon nanotubes in its laboratory waste stream. Importantly, Stanford indicated that the combined use of carbon nanotubes in all of its laboratories only amounts to approximately 16 grams per year and that its nano-waste stream is treated as “hazardous waste.”

Regarding DTSC’s fourth question concerning Stanford’s knowledge of the possible environmental, health, and safety effects of its carbon nanotubes, the University responded that it takes “a precautionary, but reasonable approach” and uses good laboratory safety practices when working with nanoscale materials. Additionally, Stanford maintained that one the articles attached to its submission supports the position that carbon nanotubes are cleared from the body without adverse health effects. Finally, Stanford indicated that it closely follows the nano-EHS literature posted on NIOSH’s website, as well as the comprehensive nano-EHS website of the International Council on Nanotechnology at Rice University.

In response to DTSC’s fifth question concerning the nano-specific workplace safety measures implemented by Stanford, the University responded that (i) it follows a standard chemical hygiene plan created and implemented under existing California law, (ii) has implemented its “General Principles and Practices for Working Safely with Engineered Nanomaterials,” and (iii) has created a standard operation procedure template for use by its nano-laboratories “to assist in determining the [appropriate] levels and types of controls” which should be used in each laboratory working with nanoscale materials. Stanford’s “General Principles” document4 can be found on its website and basically summarizes the key points from NIOSH’s “Approaches to Safe Nanotechnology” document5 in a condensed bullet point format.

Finally, regarding DTSC’s sixth “hazardous waste” question, Stanford largely mooted the question by explaining that it treats its carbon nanotube waste stream as “hazardous waste,” whether or not such material actually constitutes “hazardous waste” from a scientific and/or regulatory perspective.

On the whole, Stanford put considerable effort into its response to DTSC’s information request, but it contained no “earth shattering” revelations. The University appears to be following state of the art procedures for working safely with carbon nanotubes. More importantly, there was little information in Stanford’s response that the State did not already know or could have learned with a simple telephone call. Of course, all of this begs the question of whether a formal data call in was even necessary in the first place and/or whether California is squandering its rapidly diminishing capital on this project. At the very least, the data call in should have contained a minimum threshold requirement in order to weed out minimal users and to prevent them from having to engage in the time consuming process which Stanford went through.

References:
  1. Stanford University CNT Submittal Letter
  2. DTSC January 22, 2009, Information Request Regarding Carbon Nanotubes
  3. DTSC Carbon Nanotube Contact List
  4. Stanford's General Principles Document
  5. NIOSH's Approaches to Safe Nanotechnology

 

Nanosafety in Uncertain Times

The International Association of Nanotechnology (IANT), a non-profit organization established with the goals of fostering research and business development in Nanoscience and Nanotechnology, is sponsoring a talk and discussion on "Nanosafety in Uncertain Times"  on October 21, from 5:30PM -7:30 PM in San Jose California. The featured speaker will be John Monica Jr, a partner in Porter Wright Morris & Arthur's DC office. The focus of the evening's talk will be on AB-289, passed by the California State legislature during the 2005-2006 session and chaptered as Chapter 699. Chapter 699 added sections 57018, 57019, and 57020 to California's Health and Safety Code. While the talk and discussion are geared towards the CEOs, risk management personnel, compliance officers and safety officers of nanotech companies, anyone who wants to find out more about nanotech regulation is welcome to attend.  To register for this event, please go here.

Mapping Nano

It's almost a bit of a cliche now to say that nanotechnology is a growth field, ever expanding it's presence in government, academia and business.

With the release yesterday by the Project on Emerging Nanotechnologies (PEN) of an updated version of the Nano Metro Map, we can see that there is a good deal of truth to the cliche. The map shows the metro areas with the largest concentrations of nanoindustries,  universities, research institutes, organizations, and government agencies involved in various areas of nanotechnology.

While the map shows that California and the New England - New York region dominating, with the Research Triangle area of the Carolinas and Texas as 3rd and 4th in rank, what it also shows is the presence in all the continental states, (Alaska and Hawaii are not shown on the map), of at least one research facility, nanoindustry, etc. Nanotechnology has spread from the California and New England regions to become a national presence.

The map will be updated as PEN receives and analyzes more data. 

California Formally Requests Carbon Nanotube Information From Manufacturers

On January 22, 2009, California's Department of Toxic Substances Control (DTSC) sent a formal request to several California manufacturers and/or importers of carbon nanotubes seeking information regarding analytical test methods, environmental fate and transport, and other relevant environmental, health, and safety information regarding carbon nanotubes.  The request was issued by DTSC under its authority granted under California's Health and Safety Code 699, Sections 57018-57020.

DTSC asked manufacturers to answer the following questions:

What is the value chain for your company? For example, in what products are your carbon nanotubes used by others? In what quantities? Who are your major customers?

What sampling, detection and measurement methods are you using to monitor (detect and measure) the presence of your chemical in the workplace and the environment? Provide a full description of all required sampling, detection, measurement and verification methodologies. Provide full QA/QC protocol.

What is your knowledge about the current and projected presence of your chemical in the environment that results from manufacturing, distribution, use, and end-of-life disposal?

What is your knowledge about the safety of your chemical in terms of occupational safety, public health and the environment?

What methods are you using to protect workers in the research, development and manufacturing environment?

When released, does your material constitute a hazardous waste under California Health &Safety Code provisions? Are discarded off-spec materials a hazardous waste? Once discarded are the carbon nanotubes you produce a hazardous waste? What are your waste handling practices for carbon nanotubes?

Recipients have one year to supply the requested information.