Nanotechnology Lawyer & Attorney : Porter Wright Morris & Arthur : Nanotechnology Law Report - Germanium nanobead image provided by UT-Battelle, which manages Oak Ridge National Laboratory for the Department of Energy

To retain respect for sausages and laws, one must not watch them in the making

Prince Otto von Bismarck

On April 22, 2010, Rep. Bart Gordon of Tennessee introduced HR 5116, the America COMPETES Reauthorization Act of 2010, which was then referred to the House Committee on Science and Technology and the House Committee on Education and Labor.

The bill's focus, as it's title implies, is on reauthorizing the America COMPETES Act passed in 2007. Both the original act provided government support for innovation, research and development, increased funding for science, technology, engineering and math (STEM for short) in high schools and colleges, and assistance in getting the results of research and development out to the private sector, ultimately leading to the emergence of new industries and an expansion of the economy. The Reauthorization act would have expanded on this and would have included other areas, such as a reorganization of the National Institutes of Standards and Technology.

The House Committee on Science and Technology reported the bill out of committee with an amendment in the nature of a substitute; all of the language after the enacting clause was stripped out and new language substituted. Both the bill as introduced and the bill as reported to the House have the same language for Title I, "Science and Technology Policy", Subtitle A, "The National Nanotechnology Initiatives Amendments Act of 2010", which will be our focus here.

Section 102, "National Nanotechnology Program Amendments" would require, within 12 months of the bill's enactment into law, of a strategic plan to guide the National Science and Technology Council (NSTC) in achieving activities described in an earlier section and

to guide the activities described under subsection (b) that specifies near-term and long-term objectives for the Program, the anticipated time frame for achieving the near-term objectives, and the metrics to be used for assessing progress toward the objectives, and that describes--

 

`(A) how the Program will move results out of the laboratory and into applications for the benefit of society, including through cooperation and collaborations with nanotechnology research, development, and technology transition initiatives supported by the States;

 

`(B) how the Program will encourage and support interdisciplinary research and development in nanotechnology; and

 

`(C) proposed research in areas of national importance in accordance with the requirements of section 105 of the National Nanotechnology Initiative Amendments Act of 2010;';

 

This new language would replace the current version:

(A) how the program will move results out of the laboratory and into application for the benefit of society;

(B) the Program's support for long-term funding of interdisciplinary research and development in nanotechnology; and

(C) the allocation of funding for interagency nanotechnology projects;

Section 102 would also add new language regarding support for the development of standards for nanotechnology, funding for the National Nanotechnology Coordination Office (NNCO), by directing the NSTC to include descriptions of funding required by the NNCO to perform functions required by earlier sections an the amount of funds provided by each federal agency that participates in the program.

The NNCO would be directed to

develop and maintain a database accessible by the public of projects funded under the Environmental, Health, and Safety, the Education and Societal Dimensions, and the Nanomanufacturing program component areas, or any successor program component areas, including a description of each project, its source of funding by agency, and its funding history. For the Environmental, Health, and Safety program component area, or any successor program component area, projects shall be grouped by major objective as defined by the research plan required under section 103(b) of the National Nanotechnology Initiative Amendments Act of 2010. For the Education and Societal Dimensions program component area, or any successor program component area, the projects shall be grouped in subcategories of--

 

`(A) education in formal settings;

 

`(B) education in informal settings;

 

`(C) public outreach; and

 

`(D) ethical, legal, and other societal issues.

The requirement for a publicly accessible database has appeared in S. 1482 and H.R. 554, discussed here and here.

Section 5 would retain the requirement for the Director of the NNCO to enter into an agreement with the National Research Council (NRC) to conduct a triennial review. However, the areas covered by the review would be greatly reduced from

(1) an evaluation of the technical accomplishments of the Program, including a review of whether the Program has achieved the goals under the metrics established by the Council;

(2) a review of the Program’s management and coordination across agencies and disciplines;

(3) a review of the funding levels at each agency for the Program’s activities and the ability of each agency to achieve the Program’s stated goals with that funding;

(4) an evaluation of the Program’s success in transferring technology to the private sector;

(5) an evaluation of whether the Program has been successful in fostering interdisciplinary research and development;

(6) an evaluation of the extent to which the Program has adequately considered ethical, legal, environmental, and other appropriate societal concerns;

(7) recommendations for new or revised Program goals;

(8) recommendations for new research areas, partnerships, coordination and management mechanisms, or programs to be established to achieve the Program’s stated goals;

(9) recommendations on policy, program, and budget changes with respect to nanotechnology research and development activities;

(10) recommendations for improved metrics to evaluate the success of the Program in accomplishing its stated goals;

(11) a review of the performance of the National Nanotechnology Coordination Office and its efforts to promote access to and early application of the technologies, innovations, and expertise derived from Program activities to agency missions and systems across the Federal Government and to United States industry;

(12) an analysis of the relative position of the United States compared to other nations with respect to nanotechnology research and development, including the identification of any critical research areas where the United States should be the world leader to best achieve the goals of the Program; and

(13) an analysis of the current impact of nanotechnology on the United States economy and recommendations for increasing its future impact.

to

 `(1) research priorities and technical content of the Program, including whether the allocation of funding among program component areas, as designated according to section 2(c)(2), is appropriate;

 

 

`(2) effectiveness of the Program's management and coordination across agencies and disciplines, including an assessment of the effectiveness of the National Nanotechnology Coordination Office;

 

`(3) Program's scientific and technological accomplishments and its success in transferring technology to the private sector; and

 

`(4) adequacy of the Program's activities addressing ethical, legal, environmental, and other appropriate societal concerns, including human health concerns.

The report would be transmitted to be submitted to the Director of the NNCO, who in turn would

transmit it to the Advisory Panel, the Committee on Commerce, Science, and Transportation of the Senate, and the Committee on Science and Technology of the House of Representatives not later than September 30 of every third year, with the first report due September 30, 2010.

 The definition of "Nanotechnology" would be changed from the current

Nanotechnology

 

The term “nanotechnology” means the science and technology that will enable one to understand, measure, manipulate, and manufacture at the atomic, molecular, and supramolecular levels, aimed at creating materials, devices, and systems with fundamentally new molecular organization, properties, and functions.

 

to a more focused

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The NanoSafety Consortium for Carbon has recently posted a bibliography of in vivo tox studies on its website.  The bibliography is (obviously) a work in progress.  We would greatly appreciate it if our readers would bring to our attention any pertinent articles that are not already on the bibliography.  The articles will be used to inform and guide our attempt in crafting a representative toxicity testing regime with US EPA.  Many thanks in advance for your input.

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Members of the European Parliament’s environment, public health and food safety committee have voted to control the use of nanotechnologies in foods for humans. The proposed measure entirely excluded entry onto European Union (“EU”) markets of any food derived from cloned animals as well as food produced by nanotechnology processes, unless such food has undergone a specific risk assessment regarding possible impact on health. Those risk assessment methods must also have been approved for use, i.e., not imply the use of vertebrate animals for testing. The measure also required all ingredients containing nanomaterials to be clearly labeled by listing the names of the ingredients followed by the word 'nano' in brackets. A definition of nanomaterials was included in the proposed text as: “nanomaterial means an intentionally manufactured material with one or more external dimensions or an internal structure, of order of 100 nm or less.” The new regulation can only be adopted after co-decision by both the European Parliament and Members States and must be endorsed by the whole parliament in July.

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The Nano-Network and Wright State University are holding a joint conference on Multifunctional Nanomaterials: Cross-cutting Growth Opportunities in Energy, Environment and Aerospace Applications on May 24, 2010 at Wright State University in Dayton, Ohio.  

"The aim of this one-day networking event is to bring together leaders and sponsors from Ohio industry, AFRL, AFOSR and university faculty to discuss possible growth options and collaborative opportunities."

For more info. contact:

Ken Vaughan, Executive Director
Nano-Network
PolymerOhio Inc.
155 Commerce Park Drive, Suite 8
Westerville, Ohio 43082
Phone: (614) 776-5720
Email: kvaughan44@aol.com
URL: http://www.polymerohio.org/  
 

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The General Assembly of Maryland has concluded its annual 90 day session. Among the bills that were passed during this year's session was House Bill 795, introduced by Delegate Susan C. Lee. 

As introduced, HB 795 was to establish a "Task Force to Study Nanotechnology and Nanobiotechnology", but was amended to focus solely on Nanobiotechnology and was passed by both the MD State Senate and the House of Delegates on April 1, 2010, signed into law by Governor Martin O'Malley on April 13, 2010 and Chapterized as Chapter 163 Acts of 2010.

The Task Force is to be composed of members appointed by the President of the MD State Senate, the Speaker of the House of Delegates - these individuals will serve as co-chairs of the task force - the Secretary of Business and Economic Development, Chair of the MD Technology Development Corporation or their designees. The Governor is empowered to appoint three representatives to the task force from universities and colleges in Maryland that are involved in research in nanobiotechnology and two CEOs of nanobiotech companies. In addition, the Directors of NIH, NIST, FDA and the USPTO or their designees are also to be invited to become part of the task force.

The task force is charged with studying the benefits  of the nanobiotech industry, ranging from job creation to "the generation of revenues for the state", the state's role in supporting nanobiotech, including promoting private-public partnerships, offering financial incentives for nanobiotech companies to establish themselves in Maryland, etc.. The task force is also charged with reporting its recommendations to the Governor on or before 01/11/2011, prior to the beginning of the next General Assembly session.

The State of Maryland has been criticized lately as having an "unfriendly" business environment for existing businesses or for companies that might relocate or expand into Maryland. Such criticism may become one of the themes of the 2010 election season in the state. Forward looking legislation such as Chapter 163, designed to help attract the next generation of nanoindustry, may help to prove that criticism wrong.

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The Northeast Nanomanufacturing Summit 2010 is a showcase for high-quality technical contributions by scientists, experts, and businesses in the field of nanomanufacturing. The event will include topical papers on emerging technologies, applications, and fundamental research for academic institutions and industries in the Northeast, along with national and international contributions.

Topics will include:

• Green, Environmentally Safe NanoManufacturing
• Environmental Health & Safety
• Toxicity & Standardization
• Nanoelectronics
• Energy & Power
• Advanced Processes and Tools for Nanomanufacturing
• Nanomanufacturing Strategies for Multiscale Nanomanufacturing
• Bio-Inspired Processes
• Nanomaterials

The event will take place on June 22-24, 2010, at the Inn & Conference Center at UMass Lowell
Lowell, Massachusetts

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Inside EPA reports today that a "senior policy adviser for EPA's Office of Pesticide Programs, said EPA would issue in June a long-awaited response to a 2008 activist petition asking the agency to regulate nanoscale silver under FIFRA."  The article also mentions that EPA intends to define nanoscale ingredients for FIFRA purposes as "an ingredient that contains particles that have been intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers."

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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).

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