Readers may be interested in learning that my 2009 book "Nanotechnology Law" is now online. You can find it on Westlaw as Nanotechnology Law (NANOTECH). 

The Westlaw version is very helpful because you can now electronically search for any nano-related legal topic and let your computer do all the work -- it even provides links to the footnotes.

As another shameless plug, "Nanotechnology Law" is the only comprehensive legal text on nanotechnology currently on the market and weighs in at 1006 pages.  (All the better reason to use the Westlaw search function).

Finally, I am in the process of updating the book for the 2010 edition.  Thus, if there is anything important from 2009 that you would like to see analyzed in the 2010 edition -- please let me know and I will see what I can do.

JCM

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Today's Federal Register carries a notice of a public meeting on Tuesday March 30th and Wednesday March 31st 2010 to be held at the Holiday Inn Rosslyn-Key Bridge in Arlington Virginia .

The meeting will be a workshop designed "to provide an open forum to discuss the state-of-the-art of the science related to environmental, health, and safety aspects of nanomaterials
in two areas: Risk Management Methods and Ethical, Legal, and Societal
Implications (ELSI) of Nanotechnology."

Registration is required to attend the workshop and information on how to register is available in the notice. Anyone wishing to present 3-5 minutes of public comments also needs to register. Written or electronic comments must be submitted via e-mail at capstone@nnco.nano.gov until April 30, 2010. Written comments can also be mailed to Capstone Workshop, c/o NNCO,
4201 Wilson Blvd., Stafford II, Suite 405, Arlington, VA 22230.
 

Those unable to attend the workshop in person can view the main sessions via webcast. The draft agenda for the workshop is below. Among the invited speakers and guest is John Monica, a partner in Porter Wright's DC office. Further information about the workshop is available on the National Nanotechnology Initiative website.

Schedule and Agenda

• Email This
• Print
• Comments
• Trackbacks
• Share Link

We are all familiar, at this point in time, with the concept of "good" (HDL) and "bad" (LDL)cholesterol and with the effects of a build up of "bad" cholesterol on the walls of arteries and other blood vessels. Cardiovascular disease is now the leading cause of death in the United States, ahead of cancer.

According to an article published in late November in the New York Times, research at Northwestern University, under the direction of Drs. C. Shad Thaxton and Chad A. Mirkin, and at the Mount Sinai School of Medicine under the direction of Dr. Willem J.M. Mulder, may lead to new  tools for the diagnosis and treatment of cardiovascular disease.

Drs. Thaxton and Mirkin's work has focused on creating synthetic versions of the HDL (good cholesterol) molecule using gold nanoparticles to replace the fatty core usually found in the HDL molecule. The altered HDL molecule has been demonstrated in a pilot study to be effective in removing plaque build-ups from blood vessels, by absorbing the LDL cholesterol, just as naturally occurring HDL molecules would.

The research at Mt. Sinai has focused on developing HDL-like nanoparticles for use in different types of imaging; gold nanocrystals were most effective when used in computer tomography while iron oxide nanocrystals were more effective with MRIs. The goal of Dr. Mulder's research is to improve the imaging of hardening of the arteries due to the build-up of plaques

The potential for using the HDL-nanoparticles as treatment for cardiovascular disease, according to Dr. William O'Neill, Executive Dean for Clinical Affairs at the Miller School of Medicine at the University of Miami, "Could revolutionize cardiology".

However, as both Dr. Andre Nel, Director of the Center for Environmental Implications of Nanotechnology at UCLA and Professor Vincent M. Rotello a the University of Massachusetts at Amherst, caution, further study on the possible effects of nanoparticle accumulation in the body need to be done before wide spread use the nano-HDL in treatment for cardiovascular disease, along with exercise, diet changes etc can occur.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Last September we predicted that sometime in 2010 EPA would reverse its "distinct molecular identity" approach to determining when and whether nanoscale materials are considered New Chemical Substances requiring premanufacturing notice and approval under the Toxic Substances Control Act (TSCA).   We have been advising clients accordingly. 

Inside EPA is now reporting that "EPA toxics chief Steve Owens" . . . "is expected to announce the shift Feb. 5."

Thus, tomorrow should be an interesting day in nano-regulatory-land.  We will provide our readers with a detailed analysis should EPA in fact reverse itself on this important issue.  Stay tuned . . .

• Email This
• Print
• Comments
• Trackbacks
• Share Link

The Nanotechnology Education Act (H.R. 4502), was introduced early last week by Rep. David Wu (D-1st-OR) and co-sponsored by Rep. Daniel Lipinski (D-3rd-Ill). The bill has as it's purpose the establishment of a grant program aimed at helping secondary schools, colleges and universities to established and improve nanotechnology education programs and facilities.

The bill notes that nanotechnology "is generating scientific and technological breakthroughs that will benefit society by improving the way many things are produced" and that

Nanotechnology is likely to have a significant, positive impact on the security, economic well-being, and health of Americans as fields related to nanotechnology expand.

the bill announces its formidable goal:

In order to maximize the benefits of nanotechnology to individuals in the United States, the United States must maintain world leadership in the field, including nanoscience and microtechnology, in the face of determined competition from other nations.

To maintain that level of world leadership

the United States must make a long-term investment in educating United States students in secondary schools and institutions of higher education, so that the students are able to conduct nanoscience research and develop and commercialize nanotechnology applications.

Preparing United States students for careers in nanotechnology, including nanoscience, requires that the students have access to the necessary scientific tools, including scanning electron microscopes designed for teaching, and requires training to enable teachers and professors to use those tools in the classroom and the laboratory.

H.R. 4502 states it's purpose:

is to strengthen the capacity of United States secondary schools and institutions of higher education to prepare students for careers in nanotechnology by providing grants to those schools and institutions to provide the tools necessary for such preparation.

The Director of the National Science Foundation would be directed to "establish a nanotechnology in the schools program". To support the program, "the director shall award grants of not more than $400,000 to eligible institutions". The bill would define "eligible institutions" very broadly and would include:

1) public, private, parochial and charter schools offering one or more advanced placement science courses,

2) community colleges,

3) four year institutions of higher learning (colleges and universities), and

4) "informal learning science and technology centers". The bill does not define these informal centers any further, but this may be clarified and defined further in a committee mark-up session.

Grant funds would be used for

1) the acquisition of equipment and software for use in classrooms

2) to develop and provide educational services; that is, it would be used by teachers and other instructors to develop classes in nanotechnology

3) to pay for teacher education in nanotechnology

Equipment and software purchased with grant funds by colleges and universities would be required by the bill to be used primarily by undergraduate programs and would also be required to be mostly made in the United States.

The Director of the NSF, no later than six months following passage of HR 4502 and it's being signed into law, would need to establish the process and procedures for eligible institutions to apply for the grants. The procedures, like all other procedures for applying for government grants, would need to be published in the Federal Register and commented on by the public before going into effect. Although the bill doesn't state it, the procedures would probably also be posted to a government website for downloading. In selecting recipients for these grants, the Director would

(1) select geographically diverse institutions; grants could not all be given to institutions in one area, for example, schools in New England or California. The grants would need to be spread around the United States.

2) The Director of NSF would be required to encourage the applications of Historically Black Colleges and Universities and minority institutions as defined by section 365 of the Higher Education Act of 1965 (20 U.S.C. 1067k).

3) Select recipients located in states participating in the Experimental Program to Stimulate Competitive Research.

Institutions receiving these grants would need to raise funds equal to 1/4 of the grant amount. And, if the grant exceeds $100,000, the institution would need to wait for 2 years before it could apply for another grant. Each institution would be required to submit a report to the Director of the NSF no later than one year after the grant was awarded regarding its use of grant funds. Every three years, the Director would, on the basis of these reports, evaluate the program, assessing both short and long term impacts of activities supported by the grants. No later than six months after the evaluation, the Director would submit a report to Congress - in its current form, the bill doesnot specify which committee or committees the report would be submitted to. Again, this is something that may be clarified in a committee mark-up session. The Director's report would contain "recommendations concerning the continued need for Federal support of the program. . . ."

HR 4502 authorizes an appropriation of $40 million for FY 2011 and necessary funds for 2012-2014. The bill has been assigned to the House Committee on Science and Technology. No hearings have been scheduled.

To date, only a handful of colleges and universities offer courses or degree programs in nanotechnology, leading to a shortage of trained workers available for the jobs that are and will be created in nanoindustries. The grants that the Nanotechnology Education Act would distribute would represent an investment in preparing a trained workforce capable of stepping into those jobs.

It should be noted, however, that the bill is being introduced against the shadow of President' Obama's statement in in State of the Union speech to freeze all discretionary spending by the federal government for three years:

Starting in 2011, we are prepared to freeze government spending for three years.  Spending related to our national security, Medicare, Medicaid, and Social Security will not be affected.  But all other discretionary government programs will.  Like any cash-strapped family, we will work within a budget to invest in what we need and sacrifice what we don't.  And if I have to enforce this discipline by veto, I will. 

As with other nanotechnology related legislation filed during the 111th Congress, we'll monitor HR 4502's progress and provide updates.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

The Center for the Study of Law, Science & Technology, part of the Sandra Day O'Connor College of Law at Arizona State University,  Monash University Law School, and the Institute of Environmental and Energy Law jointly created the Nanotech Regulatory Document Archive in 2009. The archive is a free and easily searchable database of, as the name implies, documents regarding the regulation of nanotechnology, nanomaterials and nanoindustry produced by national and state governments, government agencies, and others throughout the world. Users are supposed to create an account in order to access the documents, which are in PDF formats, however the documents seem to be accessible even without setting up an account. Users may also add documents to the archives collection, which does require registering and setting up an account. Documents can either be accessed via the "Recent Documents" tab at the top of the page, by clicking on one of the countries listed on the left hand side of the page or via the search box

The database will prove useful for various groups, ranging from the general public who are just curious to business people in the nanoindustrial field who want to see what the rules and regulations are in other countries to elected representatives ( or more likely their staffs who would need to do the research in the area) who, inevitably, will be engaged in debates over the writing and enforcement of laws and regulations. Corporate Counsels  for nanotech companies and outside counsels may also find it a useful place to do research for their clients who are thinking of expanding into other countries and need to see what regulations are already in place.

The database was funded by a multi-year grant from the US Department of Energy. Due to its relatively recent establishment, there are a limited number of documents available, but I suspect that as word of it gets around and more people realize its usefulness, the database will grow.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

On Thursday 01/21/2010, Senator Mark Pryor (D-Ark) introduced S. 2942, "The Nanotechnology Safety Act of 2010", the first nanotechnology related bill of the 2nd session of the 111th Congress. The bill is co-sponsored by Senator Benjamin Cardin (D-MD). The text of S. 2942 has not yet been made available by the Government Printing Office; the link above is to Senator Pryor's introductory remarks in the Congressional Record. The text of S. 2942 as introduced follows the Senator's remarks.

In his introductory remarks Senator Pryor stated that the bill would "authorize a program of scientific investigation by the Food and Drug Administration on nanotechnology based medical and health products . . . . [to] enable the FDA to properly study how nanomaterials are absorbed by the human body, how nanomaterials designed to carry cancer fighting drugs target and kill tumors, and how nanoscale texturing of bone implants can make a stronger joint and reduce the threat of infection."

Senator Pryor also noted in his remarks that

The FDA needs the tools and resources to assure the public that nanotechnology-based medical and health products are safe and effective. The development of a regulatory framework for the use of nanomaterials in drugs, medical devices, and food additives must be based on scientific knowledge and data about each specific technology and product. Without a robust scientific framework there is no way to know what data to collect. More than a dozen material characteristics have been suggested even for relatively simple nanomaterials. Without better scientific knowledge of nanomaterials and their behavior in the human body, we do not know what data to collect and examine.

. . . the Nanotechnology Safety Act of 2010 will provide the FDA the authority necessary to scientifically study the safety and effectiveness of nanotechnology-based drugs, delivery systems, medical devices, orthopedic implants, cosmetics, and food additives regulated by the agency. This bill is a sound investment on the promise of nanotechnology to improve human health and reduce costs in the 21st Century.

The Nanotechnology Safety Act of 2010 would amend Chapter X of the Federal Food, Drug and Cosmetic Act  by adding section 1011. There would be three major parts to this new section.

Part 1 would establish a program within the FDA to investigate

(A)nanomaterials included or intended to be included in products regulated by the FDA

(B) the potential toxicity of such nanomaterials

(C) the effects of nanomaterials on biological systems

(D) the interaction of nanomaterials with biological systems.

S.2942 would also establish that the new program's purpose would include (1) assessment of the scientific literature and data on the general interaction of nanomaterials with biological systems and on specific nanomaterials of concern to the FDA (2) develop and organize information using databases and models that would enable the formation of general principles about the behavior of classes of nanomaterials with biological systems (3) promote collaborative efforts to understand the properties of nanomaterials that might contribute to possible toxicity (4) promote and participate in collaborative efforts at measurement and detection of nanomaterials (5) collect, interpret and make available scientific information and data about the interaction of nanomaterials and biological systems (6) build scientific expertise on nanomaterials (7) insure ongoing training and dissemination of new information (8) encourage FDA participation in international and national standards activities and (9) carrying out other activities that the Secretary of Health & Human Services (HHS) determines are necessary.

Part 2 of the new section, "Program Administration"  would create the position of a program manager. The position's duties would include developing "a detailed strategic plan for achieving specific short and long term technical goals . . . .", co-ordinate and integrate the strategic plan with investments from FDA and other agencies and departments that participate in the National Nanotechnology Initiative (NNI) and the development of the legal instruments (Memorandums of Understanding, etc) for cooperative arrangements necessary for meeting the long term goals of the program.

Part 2 would also require the Secretary of HHS to submit reports by 03/01/2011 and 03/01/2014 to the House and Senate Appropriations Committees, the Senate Health, Education, Labor and Pensions Committee and the House Committee on Energy and Commerce. The reports would review the short and long term goals of the program,  the coordination of activities under the program with other participants in the NNI and the current and proposed funding levels for the program and if those funding levels would support the work of the program adequately.

Part 3 would authorize an appropriation of $25 million per fiscal year from 2011 through and including 2015.

S. 2492 has been assigned to the Senate Committee on Heath, Education, Labor and Pensions. No hearings are scheduled at this time. As with legislation introduced in the first session of the 111th Congress, we will monitor and report on the bill's progress.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Last year, the French Commission of Public Debates launched a series of public debates about nanotechnology, with the purpose of presenting all aspects of nanotechnology and nanoindustry to the general public and to use the views expressed by all sides in shaping future government policies in the nanotech area.

However, according to a recent report on Science magazine's blogsite, the debates have not quite gone according to Robert's Rules of Order. A faction of French environmentalists have appeared at three of the debates using tactics similar to those of the "Tea Partiers" during last summers town hall meetings about the health care reform bills. Two of the debates had to be canceled while a third saw the audience sent away while the debate was conducted as a webcast.

Five more debates are scheduled to be held this month and February. One hopes that the remaining debates, where stakeholders and the general public can exchange views and concerns, can be held as scheduled.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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

• Email This
• Print
• Comments
• Trackbacks
• Share Link