Topics covered in the interview ranged from Wyden's work on reauthorizing the National Nanotechnology Initiative (NNI):

I very much want reauthorization before the end of the year. I think the Commerce Committee, Chairman [Jay] Rockefeller and others, have felt strongly about this and have watched this sort of bump up against the schedule again and again and again …

If ever there was a bipartisan fit for the Senate right now, and a chance to put us on the right side in terms of taking bolder action in a tough international competition with Europe and Asia, this is the time, and that’s the case I’m going to be making.

I consider the 21st Century bill that I wrote nine years ago one of the most important things I’ve done in my time in public service. 

to training a workforce that will be able to fill the good paying jobs that nanoindustry is and will be offering now and in the future.

Professor Malloy briefly describes four functions of soft law:

1- Precursive function: Laying the groundwork

" The precursive function refers to the use of soft law to lay the groundwork for later hard law instruments. . . . often [taking] the form of voluntary programs aimed at collecting information needed to design conventional hard law programs. . . . Precursive soft law programs may also focus on taking potential regulatory approaches, methodologies or standards for 'test drives', hoping to inform or improve the design of the later mandatory program."

2- Normative Function: Leveraging Social Norms

"The normative function refers to the soft law program's capacity to support the formation and activation of norms of behavior among the targeted population of businesses. . . .Here the program has the specific substantive goal of affecting the manner in which firms and individuals use and manage nanotechnology. Such programs eschew formal law. .  relying instead upon the influence of social norms and behaviors. . . .The critical point here is that where meaningful social norms regrading the appropriate health and safety practices exist, no legally enforceable regulation may be needed."

3- Directive Function: Trading Incentives

"The directive function refers to those soft law instruments having a quasi-binding nature. . .. The directive function is perhaps the closest in operation to hard law."

Professor Malloy offers the example of a company entering a certification program. If a company follows required procedures, the company and it's products gain the desired benefit of being certified by a respected body as being as good or superior to competing manufacturers or producers. The trade off is that the company, to retain that coveted certification, has to commit itself to continuing to follow the procedures, otherwise it risks the "punishment" of de-certification.

4- Complementary Function: Integrating Hard and Soft Law

"The complementary function links hard and soft law. Here soft law serves to assist in the implementation of hard law." For example, government agencies regularly issue informal "guidances" or "guidelines", non-legally binding documents "issued by an agency to clarify its interpretation of a statute or regulation. . . .It provides some level of predictability in the implementation of hard law and can serve as a focal point for engagement among the agency and interested parties."

"Soft Law and Nanotechnology: A Functional Perspective" develops these ideas in greater depth than is possible here and is well worth a read.

After briefly surveying European Union (EU) and non-EU regulatory efforts and finding them all lacking, the WECF calls for applying the precautionary principle and the principle of "no data, no market" for all nanomaterials and products containing nanomaterials.

WECF demands that full information about possible risks of nanoparticles as well as access to information on which products contain nanomaterials should be provided to the public, including developing countries) without delay.

The position paper then presents seven additional demands or "actions" by WECF:

1- "WECF demands that manufactured nanomaterials are treated as totally new substances."

2- " WECF demands the application of "no data, no market" - and in the case of REACH, this is to be independent of tonnage. Registration of nanomaterials under the corresponding bulk chemical should by default be prohibited."

3- "Nanosubstances should be subject to a far reaching health assessment (health, environment)."

4- "WECF asks decision-makers specifically to implement the precautionary principle and introduce producers liability immediately; this will render companies already producing or using nanomaterials accountable for possible damage caused by their products."

5- "Immediate compulsory labelling of all products containing nanomaterials."

6- "Citizens must be informed and involved in decision making . . . .WECF demands a wide-ranging citizens dialogue on the risks and benefits of the new technology. The decision making procedures have to become more democratic and need to be adapted to cover dynamic technological revolutions such as nanotechnology."

7- "All products for children and pregnant women must be MNM-free until it is proven that they present no health risks to those specific groups of consumers. WECf considers the sale of products without adequate risk research as absolutely irresponsible."

While the position paper does raise legitimate issues that have been raised by other groups, legislatures and interested parties, such as providing information on product labels indicating if the product does contain nanomaterials, other issues, such as the demand for public debates, are more problematic. It should be recalled that such debates were tried in France in 2010 (and discussed here), debates which ended in chaos.  The potential exists for such public forums to become the territory of demagogues. Other demands, such as "Immediate, compulsory labelling", show that WECF has no understanding of the regulatory process.

While the position paper may hold the spotlight for a short time, it probably won't have much of an impact on the EU's regulatory bodies.

At the end of 2011, the Office of the Inspector General (OIG) of the Environmental Protection Agency (EPA) posted Report No. 12-P-0162,"EPA Needs to Manage Nanomaterial Risks More Effectively" to the reports section of its website.

The OIG, in the Introduction to the report, states that the

. . .  purpose of this review was to determine how effectively the U.S. Environmental Protection Agency (EPA) is managing the human health and environmental risks of nanomaterials.

The report notes that

EPA has the statutory authority to regulate nanomaterials. . . . EPA can regulate nanomaterials during their manufacture, formulation, distribution in commerce, use, and/or disposal through the Toxic Substances Control Act (TSCA) . . . nanomaterials in pesticides through the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) . . . . EPA can regulate nanomaterials released into the environment using the Clean Air Act; the Clean Water Act; the Comprehensive Environmental Response, Compensation and Liability Act; or the Resource Conservation and Recovery Act.

However, while EPA is armed with this authority and while EPA has shifted in recent years from depending on nanoindustries to voluntarily supply EPA with information on "production, importation, and use; exposures; risk management practices; hazards; pollution prevention; and physical and chemical properties" to a more active "regulatory approach", "to collect nanomaterials data from manufacturers of industrial chemicals", the OIG, after conducting "this performance evaluation in accordance with generally accepted government auditing standards", "identified a number of shortcomings": At least some of these shortcoming were attributable to the limitations of TSCA:

1) " . . . An absence of toxicity testing and environmental fate data, and a reliance on modeling . . . .Because EPA depends on information reported by industry, it can initially fail to identify chemical risks not self-disclosed by manufacturers."

2) "The program was limited by TSCA's requirement to protect claims of confidential business information (CBI) on industry data submissions. . . . Excessive CBI designations inhibit independent peer reviews, oversight by external parties, and information sharing across EPA offices".

Other short comings are based in structural problems:

1) "EPA doesnot have an agency-wide formal process to disseminate manufacturer data gathered from TSCA and FIFRA data calls." This data is shared between offices only via informal personal relationships (a.k.a "The Grapevine") such as can be found in any office setting. While this form of communication may work to a limited extent, its limits are obvious.

"Because of the growing number of nanomaterial products entering the marketplace and the anticipated receipt of TSCA and FIFRA data following approval of . . . requested information gathering rule changes, it will be increasingly necessary for . . .offices [in EPA] to formally share information anc coordinate their efforts."

Other short comings found by the OIG recall a line from the movie Cool Hand Luke :

Captain, Road Prison 36: What we got here is... failure to communicate.
 

"Through Federal Register notices, program office web pages, public presentations, and meetings EPA has sought to communicate information related to nanomaterials and to gather input from stakeholders. However, the agency as a whole has not provided a transparent overall message about nanomaterials to the general public. . . .The agency should be prepared to communicate to the public any nonconfidential risk information generated or collected through its FIFRA, TSCA, and reseach activities because nanomaterials is emerging issue, it will be important for EPA to keep the public informed on the benefits and risks, how the public might be exposed, and what regulatory approach the agency is taking."

Other short comings are based on the limitations created by (1) a lack of technology designed to detect nanomaterials or remove detected nanomaterials from the ambient atmosphere (" . . .the agency may not be able to monitor, identify, and remediate nanomaterial comtamination if it were to occur in the natural environment") and (2) resource limitations. EPA, like all Federal, State, County and Municipal agencies, constantly face the potential for budget cuts that would severely limit agency programs.

The OIG's report concludes with the recommendation that the EPA's Assistant Administrator for Chemical Safety and Pollution Prevention be tasked with developing "a formal process to assure the effective dissemination and coordination of nanomaterial information across relevant program offices."

While EPA has agreed with this recommendation and has created a "correction plan with milestone dates" to create a formal communications process and structure, other shortcomings, as discussed above, are rooted in the limitations of TSCA, FIFRa and other laws refered to above. Changes in those are outside of EPA's control, as are those caused by the vagaries of budgets and the appropriations process.

Legislation to reform and strengthen TSCA and EPA's regulatory authority have been introduced in both the Senate and the House in both the 111th and 112th Congresses. S.847, the Safe Chemicals Act of 2011, introduced by Senator Frank Lautenberg of New Jersey on April 14, 2011, is the most recent of these bills. Assigned to the Senate Committee on Environment and Public Works Subcommittee on Superfund, Toxics and Environmental Health, hearings on the bill were held on November 17, 2011. No further action on the bill has occured and with elections coming in November of this year, it is unlikely that the bill will be reported out of committee and sent to the Senate floor for debate.

ObservatoryNANO was created and funded by the then extant European Community (EC), the predecessor of today'sEuropean Union (EU),  “to create a European Observatory on Nanotechnologies to present reliable, complete and responsible science-based and economic expert analysis, across different technology sectors, establish dialogue with decision makers and others regarding the benefits and opportunities, balanced against barriers and risks, and allow them to take action to ensure that scientific and technological developments are realized as socio-economic benefits.”

The Guide sets out and briefly discusses four "tools to identify and manage nanotechnology-related priorities":

Tool 1: Set priorities, focusing on the process of framing responsibility measures

Tool 2: Check and complement established internal guidelines and code of conduct

Tool 3: Focus actions, described in the guide as the "strategies and programmes [needed] to be put in place to assure that a guideline is of any practicle use".

Tool 4: Inform transparently, focusing on what to communicate (content), how to communicate to employees of the company, customers and/or the general public, and the choice of communication media, ranging from company websites to product labels.

The Guide has links to "Good Practice Examples", such as BASF's Code of Conduct and to sites where more information can be found.

While the Guide to Responsible Nano-Business is not on the same level as "Guide for the Perplexed" by Moses Maimonides, it is a good short and clearly written work that the owners and managers of nano-businesses would find useful in formulating policies for the workplace and for communicating with the general public.

According to Dr. Suresh's prepared statement, the 2013 request, "totals $7.373 billion, an increase of $340.0 million (4.8 percent) over the FY 2012 enacted level . . . . [Providing] increased support for core programs in fundemental research and education in all fields of science and engineering".

Dr. Suresh's prepared statement reflects the reality of budget constraints imposed by the Federal government's need to reduce the level of the Federal deficit. noting that "As good stewards of the public trust, we have reduced or eliminated lower priority programs . . . . "

Among the programs targeted for reductions in funding are the Nanoscale Science and Engineering Centers (NSECS). . . .

because the state of research in this area has matured significantly and the research should advance more rapidly in  a different, more use-inspired research center program. Several NSECS grants may transition to the Nanosystems Engineering Research Centers (NERCS) as the nanodevices and processes created at graduating NSECSs move to the systems level and potential commercialization. NSF will continue to support eleven NSECs in FY 2013 including the Nanomanufacturing ERC.

As described in a 2001 program solicitation the NSECs could be be "based at a single institution or may consist of a lead institution in partnership with one or more partner institutions".  These Centers were designed to

address opportunities that are too complex and multi-faceted for individuals or small groups of researchers to tackle on their own. They will bring together researchers with diverse expertise, in partnership with industry, government laboratories, and/or partners from other sectors, to address complex, interdisciplinary challenges in nanoscale science and engineering, and will integrate research with education both internally and through a variety of partnership activities. Each center, whether based at a single institution or distributed across a number of institutions, must have an overarching research and education theme, well-integrated programs, and a coherent and effective management plan. The NSECs as a whole will span the range from exploratory research, focused on discovery, to technology innovation and will involve a broad spectrum of disciplines such as engineering, mathematics, computer science, the physical sciences, earth science, and biological sciences.

The following is a list of these centers:

Center for Hierarchical Manufacturing
University of Massachusetts—Amherst

Center for Nanoscale Systems (NSEC)
Cornell University

Science of Nanoscale Systems and their Device Applications (NSEC)
Harvard University

Center for Biological and Environmental Nanotechnology
Rice University

Center for Integrated Nanopatterning and Detection Technologies (NSEC)
Northwestern University

Center for Electron Transport in Molecular Nanostructures (NSEC)
Columbia University

Center for Directed Assembly of Nanostructures (NSEC)
Rensselaer Polytechnic Institute

Center for Scalable and Integrated Nano-Manufacturing (NSEC)
University of California—Los Angeles

Center for Chemical-Electrical-Mechanical Manufacturing Systems (NSEC)
University of Illinois, Urbana-Champaign

Center on Templated Synthesis and Assembly at the Nanoscale
University of Wisconsin

Center for Probing the Nanoscale
Stanford University

Center for Affordable Nanoengineering of Polymeric Biomedical Devices
Ohio State University

Center of Integrated Nanomechanical Systems
University of California—Berkeley

Nano-Bio Interface Center
University of Pennsylvania

Center for High Rate Nanomanufacturing
Northeastern University

Center for Nanotechnology in Society
Arizona State University

Center for Nanotechnology in Society
University of California—Santa Barbara

Societal Interactions with Nanotechnology—NanoCenter
University of South Carolina

Dr. Suresh's statement does not indicate how much funding is being cut from the NSECs program budget.

As with other Federal Departments and agencies, this hearing was only the beginning of what can sometimes be a tedious and fractious process. While the possibility of Congress increasing NSF's FY 2013 budget over President Obama's request, the more likely possibility is of it being reduced further from the proposed $7.373 billion.

We'll continue to monitor the NSF budget as it makes it's way through Congress and will post updates.

This workshop will bring together leaders of regional, state, and local
organizations to engage in dialog with the Federal government; economic
development groups; investors and entrepreneurs; technology leaders;
and scientists and engineers from industry, business, government, and
academia. The discussion will address a wide range of resource,
organizational, and policy issues impacting RSL nanotechnology
initiatives.
 

Principal themes addressed in the workshop will include:

• Current landscape of U.S. RSL nanotechnology initiatives and their health

• Current Federal resources available for RSLs

• RSL best practices, business models, and opportunities for partnering; and

• Role of nanotechnology RSLs in future U.S. economic growth and job creation.

 

The workshop is cosponsored by the National Nanotechnology Initiative (NNI) and theOregon Nanoscience and Microtechnologies Institutes (ONAMI).

Anyone planning to attend the workshop is required to register, either online, via e-mail ( RSL12@nnco.nano.gov ) or via regular US mail (  RSL 2012 Workshop, c/o NNCO, 4201 Wilson Boulevard,  Stafford II, Suite 405, Arlington, VA 22230). Registration is on a "first come, first served" basis and runs from today, March 5, 2012 until 5PM April 27, 2012. Those interested in presenting 3-5 minutes of public comments at the meeting should also register at http://www.nano.gov/rslregistration. Written or  electronic comments should be submitted by email to RSL12@nnco.nano.gov  until April 27, 2012. The workshop will include an opportunity for any
regional, state, or local nanotechnology initiative or related  organization to present a poster explaining the activity.
 

FOR FURTHER INFORMATION CONTACT: For information regarding this Notice,
please contact James Kadtke or Halyna Paikoush at the National
Nanotechnology Coordination Office by telephone (703-292-8626) or email
(RSL12@nnco.nano.gov).

A draft agenda has not yet been posted to the website. Once the agenda for the workshop is available, a link to it will be posted.

seven business-led projects that will focus on developing therapeutic agents and diagnostics where nanoscale technologies are at the heart of the innovation.

The aim of the investment is to help ensure that the UK can become an early competitive adopter of these novel technologies and rapidly meet the urgent and difficult challenges posed within the worldwide healthcare sector, by translating world-class early stage ideas from academia and commercialising them through building supply chains with innovative businesses.

The funding is conditional, subject to compliance and financial reviews by EPSRC and TSB. The U.K. views this funding as actively supporting growth in the British economy through healthcare technologies.

The companies involved in these projects are:

Critical Pharmaceuticals Ltd

Johnson Matthey plc

 Mologic Ltd

Nanomerics Ltd

OJ-Bio Ltd

Renishaw Diagnostics Ltd

Sharp Laboratories of Europe Ltd., a subsidiary of Sharp Corporation of Japan.

A list of the projects funded by the grants may be found here.

Objectives:

• Provide focus to broad policy debates by working through scenarios under which specific engineered nanomaterials might be released from products;

The NanoRelease Project is overseen by a Steering Committee composed of "Government officials, chemical manufacturers, and representives of labor and consumer advocacy groups." Among the members of the Steering Committee is John Monica, Jr, a partner in the DC office of Porter, Wright, Morris & Arthur LLP.

As the article notes, Carbon Nanotubes (CNTs) are currently incorporated into a growing number of consumer products and numerous new applications and products containing CNTs are expected in the future, products that would benefit from having CNTs as part of their matrix by being stronger, lighter and more energy efficient, ranging from the PC, laptop, or notebook that you're reading this on to sporting goods, such as tennis raquets. As CNTs become more widely used in consumer products it is necessary to develop the analytical tools and procedures to mesure potential negative effects on the environment and human health from CNTs relesed during the manufacturing process and use of products, tools and procedures that would ultimately lead to the development of safer consumer products.

More information on the NanoRelease Project is available on its website.

The symposium will focus on

the scope of economic impacts of nanotechnology, input and output factors, metrics for other technological assessments, and consideration of the appropriateness of these metrics for nanotechnology materials and products. Topics addressed will include the role of research funding portfolios, intellectual property frameworks, venture capital, public-private partnerships, state and local initiatives, international cooperation, and metrics such as private sector and industry investments, patents and publications, and the development of a technologically-educated workforce as metrics for nanotechnology.

Confirmed as speakers at the symposium are:

• Françoise Roure, Organisation for Economic Co-operation and Development

• Gregory Tassey, National Institute of Standards and Technology, United States

• Mark Morrison, Institute for Nanotechnology, United Kingdom

• Adalberto Fazzio, Ministry of Science, Technology and Innovation, Brazil

• Kazunobu Tanaka, Japan Science and Technology Agency, Japan

• Altaf Carim, Office of Science and Technology Policy, United States

• Herbert von Bose, European Commission

• Joseph Molapisi, Department of Science and Technology, South Africa

• GV Ramaraju, Department of Information Technology, India

• Tom Crawley, Spinverse

• Philip Shapira, Georgia Institute of Technology

• Francis Peters, Michelin Worldwide

• Travis Earles, Lockheed Martin

• Lawrence Tamarkin, CytImmune Sciences, Inc.

• Joerg Vienken, Fresenius Medical Care

• Hilary Flynn, Lux Research

• Reinhold Crotogino, ArboraNano

• Peter Kruger, Bayer

• Kalpana Sastry, National Academy of Agricultural Research Management, India

• Victor Berucci Neto, The Brazilian Agricultural Research Corporation

• Mike Roco, National Science Foundation, United States

• Ajit Jillavenkatesa, National Institute of Standards and Technology, United States

• Douglas Robinson, teQnode

• Diana Bowman, University of Michigan

• Tateo Arimoto, Japan Science and Technology Agency, Japan

• Julia Lane, National Science Foundation, United States

• Esper Cavalheiro, Center for Strategic Studies and Management Science, Technology and Innovation

• Leonid Gokhberg, National Research University 'Higher School of Economics'

• Ben Walsh, Oakdene Hollins

• Bertrand Loubaton, GE Healthcare Europe

• Richard Clinch, University of Baltimore

• Bertrand Loubaton, GE Healthcare

• Eunmi Jung, Korea Institute for Industrial Economics and Trade, Korea

• Oleg Karasev, National Research University 'Higher School of Economics'

• Kristen Loughery, Environmental Protection Agency, United States

• Rosalie Ruegg, TIA Consulting

 

A draft verion of the symposium agenda may be found here.

Due to space limitations pre-registration for the symposium is required and begins on Friday 02/10/2012. Pre-registration is on a "first come, first served" basis and continues until capacity is reached or until 03/23/2012.

Those wishing to attend can register online at www.nano.gov/symposium, via e-mail to symposium@nnco.nano.gov or via snail mail at the following address:

International Symposium on Assessing the Economic Impact of Nanotechnology,

c/o NNCO,

4201 Wilson Blvd.,

Stafford II, Suite 405,

Arlington, VA 22230

Anyone who would like to present 3-5 minutes of public comments at the symposium should register online. Written comments may be submitted to symposium@nnco.nano.gov until 03/23/2012..

As noted here in October 2010, Professors Geim and Novoselov were awarded the Nobel Prize in Physics for their discovery of graphene.

The two new knights join Sir Mark Edward Welland, head of theUniversity of Cambridge's Nanoscience Centre, in being honored for their contributions to the fields of nanotechnology and nanoparticle research. Sir Mark's knighthood was discussed here inJune 2011.

According to a press release on the University of Manchester's site, Professor Geim seemed to be taking his knighthood in stride:

Professor Geim said: “In my life, I have got used to being called four-letter names. Going down to three is a completely new experience which I will hopefully enjoy.”

Rule Britannia.

(1) Declaring that the Defendants have violated the Administrative Procedure Act by failing to respond to the 2006 Petition within a reasonable time;

(2) Declaring that the Defendants continue to be in violation of the Administrative Procedure Act by failing to respond to the 2006 Petition;

(3) Ordering Defendants to respond to the 2006 Petition as soon as reasonably practicable"

In May of 2006, ICTA filed a "Petition Requesting FDA Amend Its Regulations for Products Composed of Engineered Nanoparticles Generally and Sunscreen Drug Products Composed of Engineered Nanoparticles Specifically". The petition requested "that the Commissioner undertake the following actions with regards to all nanomaterial products:

1) Amend FDA regulations to include nanotechnology definitions necessary to properly regulate nanomaterial products . . . .

2) Issue a formal advisory opinion explaining FDA's position regarding engineered nanoparticles in products regulated by FDA.

3) Enact new regulations directed at FDA oversight of nanomaterial products establishing and requiring . . .that: nanoparticles be treated as new substances; nanomaterials be subjected to nano-spefic paradigms of health and safety testing; and that nanomaterial products be labeled to delineate all nanoparticle ingredients

4) Any currently existing or future regulatory FDA programs for nanomaterial products must comply with the requirements of the National Environmental Policy Act (NEPA) including . . . that FDA conduct a Programmatic Environmental Impact Statement (PEIS) reviewing the impacts of nanomaterial products on human health and the environment.

Petitioners request that the Commissioner undertake the following actions with regard to nanomaterial sunscreen drug products:

5) Reopen the Administrative Record of the Final Over the Counter (OTC) Sunscreen Drug Product Monograph for the purpose of considering and analyzing information on engineered nanoparticles of zinc oxide and titanium dioxide currently used in sunscreens.

6) Amend the OTC Sunscreen Drug Monograph to address engineered nanoparticles, instructing that sunscreen products containing engineered nanoparticles are not covered under the Mongraph and instead are "new drugs" for which manufacturers must complete a New Drug Application. . . .

7) Declare all currently available sunscreen drug products containing engineered nanoparticles of zinx oxide and titanium dioxide as an imminent hazard to public health and order entities using the nanoparticles in sunscreens regulated by FDA to cease manufacture until FDA's Sunscreen Drug Monograph is finalized and FDA nanotechnology regulations are developed and implemented.

8) Request a recall from manufacturers of all pulically available sunscreen drug products containing engineered nanoparticles of titatium dioxide and/or zinc oxide until the manufacturers . . .complete new drug applications, those applications are approved by the agency, and the manufactureres otherwise comply with FDA's relevant nanomaterial product testing regulations.

FDA held open meetings and established docket FDA -2006-P-0213 (two versions of this docket exist, on Regulations.gov and on the FDA's site). Comments were filed by various stakeholders between 2006 and 2009. Many of these comments, such as those submitted by Purest Colloids Inc and the Cosmetic, Toiletry and Fragrance Association (CFTA) severly criticized the ITCA's petition and urged the FDA not to take the actions requested in the petition.

In an interim response dated Nov. 9, 2006, Randall W. Lutter, then the FDA's Associate Commissioner for Policy and Planning noted that the

. . .FDA has been unable to reach a decision on your petition because it raises complex issues requiring extensive review and analysis by agency officials. . . . We will respond to your petition as soon as we have reached a decision on your requests.

Almost six years later, FDA is still in the process of formulating regulations and policy affecting nanotechnology and nanoindustry.

The parties in the case have been referred by the US Distirct Court to Alternative Dispute Resolution. We will continue to monitor the case and update as warranted.

UPDATE:

The parties in International Center for Technology Assessment et al v Hamburg, in a stipulation filed with the court on January 13, 2012, agreed  to grant the EPA " an extension of time to April 23, 2012 to answer, move, or otherwise respond to the complaint". EPA requested the extension "because defendent is working in good faith to respond to the citizen petition . . .on or before April 23, 2012."

As before, we'll keep monitoring and updating as warranted.

This investment also means that over 2500 existing jobs will remain in New York and 2500 new jobs will be created directly by the consortium, slong with an estimated 1900 construction jobs that will be created to renovate existing and to construct new facilities.

To help support the R&D work, the state government of New York will direct $400 million, also over a five year period, to SUNYCollege of Nanoscale Science and Engineering in Albany. In addition, it is expected that further investment and job creation will result from the purchase of goods and services by the members of the consortium from local businesses.

Although the announcement was greeted with praise by the Business Council of New York State, it was greeted with more cautious optimism by the local newspaper and by local government officials.

As that noted philosopher, wordsmith, catcher and manager of the New York Yankees and the New York Mets,  Lawrence "Yogi" Berra once expressed, "It's deja vu all over again."

H.R. 2359 is an only slightly changed version of H.R. 5786, the "Safe Cosmetics Act of 2010", introduced by Rep. Schakowsky on July 20, 2010 and referred to the same House Committees (the House Committee on Education and the Workforce was then known as the House Committee on Education and Labor) and discussed here on July 26, 2010.

The language affecting nanoparticles in cosmetics, section 613 in H.R. 2359, is the same as it was in section 618 of the previous bill:

SEC. 613. INGREDIENTS LABELS ON COSMETICS

 

`(d) Labeling of Nanomaterials in Cosmetics- The Secretary may require that--

 

`(1) minerals and other particulate ingredients be labeled as `nano-scale' on a cosmetic ingredient label or list if not less than 1 percent of the ingredient particles in the cosmetic are 100 nanometers or smaller in not less than 1 dimension; and

 

`(2) other ingredients in a cosmetic be designated with scale-specific information on a cosmetic ingredient label or list if such ingredients possess scale-specific hazard properties.

Similarly, the language of section 614 in H.R. 5786 is now part of section 615 in H.R. 2359:

SEC. 615. COSMETIC AND INGREDIENT SAFETY INFORMATION.

`(2) CONSIDERATION OF NANOMATERIALS- The Secretary shall--

 

`(A) monitor developments in the scientific understanding from any adverse health effects related to the use of nanotechnology in the formulation of cosmetic (including progress in the standardization of testing methods and specific size definitions for nanomaterials); and

 

`(B) consider scale specific hazard properties of ingredients when reviewing and evaluating the safety of cosmetics and ingredients under paragraph (1).

 

No hearings on H.R. 5786 were ever held, nor was it reported out of committee. No hearings are currently scheduled for H.R. 2359.

Noting that "There is no single source of information that provides an overview of nanomaterials and products in Denmark or in the EU for that matter",

DEPA has therefore initiated this project to provide an overview of the existing knowledge about seven of the most common nanomaterials, their environmental and health properties, the use of those nanomaterials and the possibility of exposure of humans and the environment.

The seven nanomaterials selected as the focus of the survey are

1 - Titanium dioxide

2 - Cerium dioxide

3- Fullerenes (aka carbon balls or 'buckeyballs")

4- Nanosilver

5- Zero-valent iron

6 - Silicium dioxide

7 - Nanoclay

These nanomaterials were selected based on

1- Application volums

2- Potential human exposure

3- Potential direct discharge into the environment

4 - Expected biological effect (human and/or environment), persistence or bioaccumultion

The authors of the survey developed "profiles" for the nanomaterials, focusing on " the general characteristics and manufacture of the nanomaterial, their current uses (mainly focused at consumer products) and hazard profiles (ecotoxicity and human toxicity) . . . . The profiles included sections discussing relevant exposures from consumer products and considerations regarding the related risk."

The first two chapters of the survey, "Introduction" and "Nanomaterials Survey" discuss the nature of the nanomaterials, their use in industries, general availability of products incorporating the nanomaterials and brief summaries of earlier studies. Chapters 3-9 focus on the individual nanomaterials selected for this survey, discussing the general characteristics of a specific nanomaterial, how it is manufactured, which consumer products available in Denmark, either via a website or a bricks and mortor shop, review of toxicity studies, possible scenarios where humans and the environment might be exposed to the nanomaterials, ranging from disposal of products containing nanomaterials in landfills to the use of nanomaterial ensconced cosmetics, such as sunscreens containing titanium dioxide, and brief discussions of "risk profiles" for the selected nanomaterials. Summary sheets are found at the end of the chapters.

Chapter 10, "Exposure and risk potential", raises a point that critics of this survey will note:

. . . the range of toxicological and ecotoxicological studies available is not sufficient to allow firm conclusions with regard to the toxicity of the nanoparticles compared to their bulk counterparts. . . (emphasis added)

As one might then expect, the authors of this survey come to the conclusion that, in order to answer the questions regarding nanomaterials and risk more information and research is needed.

According to Rep. Honda's remarks of August 1,2011

. . . the bill addresses concerns that have been raised about whether the Federal Government is doing enough to address potential health and safety risks associated with nanotechnology. The NANO Act requires the development of a nanotechnology research strategy that establishes research priorities for the Federal Government and industry that will ensure the development and responsible stewardship of nanotechnology. This strategy will help to resolve the uncertainty that is one of the major obstacles to the commercialization of nanotechnology--uncertainty about what the risks might be and uncertainty about how the Federal Government might regulate nanotechnology in the future.

• The NANO Act also includes a number of provisions to create partnerships, raise awareness, and implement strategic policies to resolve obstacles and promote nanotechnology. It will: create a public-private investment partnership to address the nanotechnology commercialization gap; establish a tax credit for investment in nanotechnology firms; authorize a grant program to support the establishment and development of nanotechnology incubators; establish a Nanoscale Science and Engineering Center for ``nano-CAD'' tools; establish grant programs for nanotechnology research to address specific challenges in the areas of energy, environment, homeland security, and health; establish a tax credit for nanotechnology education and training program expenses; establish a grant program to support the development of curriculum materials for interdisciplinary nanotechnology courses at higher education institutions; direct NSF to establish a program to encourage manufacturing companies to enter into partnerships with occupational training centers for the development of training to support nanotechnology manufacturing; and call for the development of a strategy for increasing interaction on nanotechnology interests between DOE national labs and the informal science education community.

Title I, "Investment in Nanotechnology Industry", directs the Secretary of Commerce to "establish the Nanomanufacturing Investment Partnership (NIP) . . .with private sector investments", contingent on the private sector raising $100,000,000 within two years of the NANO act being passed and signed into law. Although it's unstated in the text of the bill, should the private sector fail to raise the $100,000,000 by the end of the two years, the NIP would not be established and Title I rendered moot.

The NIP's purpose would be to

provide funding for precommercial nanomanufacturing research and development projects, . . .  through funding mechanisms described in subsection (c) in a manner so as to advance the commercialization of nanomanufacturing technologies to address critical scientific and engineering needs of national importance, especially with respect to projects that would not be adequately funded or pursued by the private sector or pursuant to the 21st Century Nanotechnology Research and Development Act or other law, and to increase the commercial application of federally supported research results. . . .at least 85 percent of the funding provided by the Nanomanufacturing Investment Partnership under this section shall be provided to startup companies.

The funding would be in the form of "direct investments . . .contracts, loans, or loan guarantees, unsecured subordinated debt, or any other mechanism designed to advance nanomanufacturing technologies". In turn, the start-up enterprises that received investments from NIP would "return to the Nanotechnology Investment Partnership. . .. fair and reasonable amounts resulting from the commercialization of technologies developed with funding provided by the Nanotechnology Investment Partnership."

An Advisory Board consisting of

(A) representatives of each investor providing more than $10,000,000 to the Nanomanufacturing Investment Partnership, whose votes shall--

 

(i) be distributed proportional to the size of their investment in the Nanomanufacturing Investment Partnership; and

 

(ii) collectively amount to 40 percent of the votes on the Advisory Board; and

 

(B) independent experts on nanomanufacturing and finance appointed by the President from among representatives of government, industry, and academia, whose votes shall collectively amount to 60 percent of the votes on the Advisory Board.

 

would be established to assist the Secretary of Commerce in making awards.

Section 102 of the NANO Act would create a tax credit to encourage the purchase of "qualified technology developer stock", defined as  meaning ". . . any common stock in a C Corporation or any membership unit in a state registered limited liability company  . . . "

The act defines a "qualified technology developer as ". . .  any entity

`(A) which is a C corporation or limited liability company organized under the laws of any State or of the United States,

 

`(B) which is a small business concern (as defined in section 3(a) of the Small Business Act), and

 

`(C) with respect to which a certification under subsection (d) is in effect. . . .

 

 

`(d) Certification-

 

`(1) IN GENERAL- The Secretary, in consultation with the National Nanotechnology Coordination Office, shall certify an entity under this subsection if such entity demonstrates by the submission of such information as required by the Secretary that not less than 51 percent of its activities relate to the development, production, and sale of products using nanotechnology.

 

`(2) REVOCATION- The Secretary shall revoke the certification of any entity which is certified under paragraph (1) if the Secretary determines that--

 

`(A) the proceeds from any qualified nanotechnology developer stock issued by such entity are used during the 5-year period following such issue for a purpose other than the development, production, or sale of products using nanotechnology, or

 

`(B) such entity no longer meets the requirements of paragraph (1).

 

Section 103 would direct the Secretary of Commerce to award competitive grants for the acquisition/renovation of space to serve as nanomanufacturing "incubators", defined as meaning

an entity affiliated with or housed in a degree-granting institution that provides space and coordinated and specialized services to entrepreneurial businesses that work in the field of nanotechnology commercialization and that meets selected criteria during the businesses' startup phase, including providing services such as shared office space and services, access to equipment, access to telecommunications and technology services, flexible leases, specialized management assistance, access to financing, and other coordinated business or technical support services.

Other grants would be awarded to develop "curricula related to nanotechnology;

 (II) providing services for commercialization, including preparing providing services to appropriate businesses including corporate charters, partnership agreements, and basic contracts, assistance with patents, trademarks, and copyrights, and technology acquisition services; or

(III) providing programming for entrepreneurs working in nanotechnology housed in an incubator;

Other grants would be awarded "for feasibility studies for determining the need for or siting of incubators, and for "research regarding best practices for incubator programs. . . ."

The Secretary of Commerce

shall establish a Nanotechnology Startup Advisory Council composed of industry leaders, business and marketing professionals, venture capitalists, attorneys, and nanotechnology researchers.

 

(2) PURPOSE- The purpose of the Nanotechnology Startup Advisory Council is to ensure that emerging nanotechnology companies create a sound foundation for new business.

 

Title II, "Research and Development Directions", contains provisions directing the Secretaries of Energy, Homeland Security, Health and Human Services, and the Administrator of the Environmental Protection Agency (EPA), to establish grant programs for nanotechnology research "to address the need for "clean, cheap, renewable energy","sensors and other materials related to Homeland Security needs", "Health related applications of nanotechnology", and "technologies for the remediation of pollution and other environmental protection technologies".

Title III, "Environmental Nanotechnology Applications", requires the Director of the National Nanotechnology Coordination Office, not later tahn one year following enactment of the NANO Act to

. . . after consultation with appropriate Federal agencies and industry, transmit to the Congress a report containing a nanotechnology research strategy that establishes priorities for the Federal Government and industry that will ensure the development and responsible stewardship of nanotechnology. The report shall include recommendations regarding the funding levels the Director anticipates the agencies charged with implementing this research strategy will require

Title IV, "Education" would create a tax credit

for the taxable year an amount equal to 50 percent of nanotechnology education and training program expenses paid or incurred by the taxpayer for the benefit of--

 

`(A) in the case of a taxpayer engaged in a trade or business, an employee of the taxpayer, or

 

`(B) in the case of a taxpayer who is an individual not so engaged, such individual. . . .

`(c) Nanotechnology Education and Training Program Expenses- For purposes of this section--

 

`(1) IN GENERAL- The term `nanotechnology education and training program expenses' means expenses paid or incurred by reason of the participation of the taxpayer (or any employee of the taxpayer) in any nanotechnology education and training program. Such expenses shall include expenses paid in connection with--

 

`(A) course work,

 

`(B) certification testing,

 

`(C) programs carried out under the Act of August 16, 1937 (50 Stat. 664, chapter 663; 29 U.S.C. 50 et seq.) which are registered by the Department of Labor, and

 

`(D) other expenses that are essential to assessing skill acquisition.

 

`(2) NANOTECHNOLOGY EDUCATION AND TRAINING PROGRAM- The term `nanotechnology education and training program' means a training program in nanotechnology workplace disciplines or other skill sets which is provided in the United States by an accredited college, university, private career school, postsecondary educational institution, a commercial nanotechnology provider, or an employer-owned nanotechnology training organization. . . .

SEC. 402. ELIGIBLE EDUCATIONAL INSTITUTION.

 

(a) In General- Section 25A(f)(2) of the Internal Revenue Code of 1986 (relating to eligible educational institution) is amended to read as follows:

 

`(2) ELIGIBLE EDUCATIONAL INSTITUTION- The term `eligible educational institution' means--

 

`(A) an institution--

 

`(i) which is described in section 101(b) or 102(a) of the Higher Education Act of 1965, and

 

`(ii) which is eligible to participate in a program under title IV of such Act, or

 

`(B) a commercial nanotechnology training provider (as defined in section 30E(c)(3)).'.

The National Science Foundation (NSF) would be directed to establish a competitive grant program to assist with the cost of developing "curriculum materials for interdisciplinary nanotechnology courses at institutions of higher learning". NSF would also be required, through the Advanced Technological Education Program, to "establish a program to encourage manufacturing companies to enter into partnerships with occupational training centers for the development of training to support nanotechnology manufacturing."

Title V, "Public Outreach", directs the Secretary of Energy

Not later than 6 months after the date of enactment of this Act, the Secretary of Energy shall transmit to the Congress a report containing a strategy for increasing interaction on nanotechnology issues between scientists and engineers at the Department of Energy's National Laboratories and in the informal science education community, to enable researchers to use their expertise to assist in the development of appropriate nanotechnology exhibitions for school age children and the general public.

H.R. 2745 has been referred to the House Committees on Science, Space and Technology, Energy and Commerce, Homeland Security, and Ways and Means, "for consideration of such provisions as fall within the jurisdiction of the committee concerned."

Any consideration of H.R. 2745 will not occur until the House  returns from recess on September 6.

The 30 day extension was requested by four commenters - Croplife America, a trade group repsenting " the developers, manufacturers, formulators and distributors of plant science solutions for agriculture and pest management in the United States", the American Chemical Council, the Chemical Producers and Distributors Association, a trade group "representing the interests of generic pesticide registrants, with a membership that includes manufacturers, formulators, and distributors of pesticide products", and theInternational Center for Technology Assessment, "a non-profit, bi-partisan organization committed to providing the public with full assessments and analyses of technological impacts on society". The comments may beviewed on Regulations.gov.

Information on submitting comments is available from either the original notice or the notice published on Wednesday.

 LCDs to display about 50% more color than they can today. This means richer, more viscerally alive reds, a deeper palette of greens (the color the human eye sees more intensely than any other color) and vivid blues. Browsing through photos on a tablet is now more like holding a stack of high quality, professional prints. Watching a movie on a big screen in the living room is more akin to attending a private screening at a Hollywood studio.

Other companies, such as Samsung Electronics and QD Vision of Massachusetts, have also begun to design, test and market their own products with the same goal as Nanosys - using quantum dots to improve the picture quality and color range of LCDs, efficently and at low cost.

As the Commerce Committee considers a reauthorization of the National Nanotechnology Initiative, the hearing will examine the potential of nanotechnology, federal initiatives to coordinate research investments, barriers to commercialization, possible environmental and health risks, and steps Congress can take to improve the return on federal nanotechnology investments.

Appearing before the Subcommittee are the following witnesses:

• Dr. Chad A. Mirkin
  Director, International Institute for Nanotechnology, Northwestern University
  Member of the President’s Council of Advisors on Science and Technology

• Dr. Charles (Chuck) H. Romine
  Acting Associate Director, Laboratory Programs, and Principal Deputy, Office of the Director
  National Institute of Standards and Technology

• Dr. Diandra Leslie-Pelecky
  Director, West Virginia Nano Initiative
  Professor of Physics, West Virginia University

• Dr. Thomas O'Neal
  Associate Vice President for Research and Commercialization, University of Central Florida
  Executive Director, University of Central Florida Business Incubation Program

• Dr. George L. McLendon
  Howard R. Hughes Provost and Professor of Chemistry
  Rice University

 

The hearing will also be webcast on the Committee's website. The witnesses prepared statements will be posted to the Subcommittee's site the day of the hearing.