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

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.

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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.

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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.

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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

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Our readers might be interested in seeing an article published by BNA's Toxics Law Report which was published on December 3, 2009 -- "Nanotechnology: The Next Battleground for Mass Torts?"  The article by a prominent California attorney and one of his Chicago-based associates is primarily a summary of our prior October 2008 article: "A Nano-Mesothelioma False Alarm" with a few added procedural suggestions for defense attorneys.  Glad to see someone out there is reading.  :)

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Earlier today, an IEEE blogger commented on a nanosilver article we previously re-published on this cite.   The original article was written by the Silver Nanotechnology Working Group and was first published on the University of Massachusetts, Amherst's InterNano website (where I am Contibuting Editor for Environmental, Health and Safety and Regulation). 

Dexter Johnson comments on the Nanoclast blog of IEEE's Spectrum website:

"In what must come as a blow to NGOs around the world it turns out that the material that has fueled much of their indignation about nanotechnology, nanosilver, has not only been 'rationally manufactured, regulated, and used commercially for over a century with no significant adverse environmental, health, and safety effects', but also the EPA has specifically been looking at nanosilver as far back as the 1950s."

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