Nanotechnology Law Report

Nanoforart

Robert Oszakiewski — Thu, 07 Mar 2013 15:16:26 -0500

"A thing of beauty" , as John Keats once wrote, may be "a joy forever", but works of art, whether they are sculptures, paintings, buildings, or books, do not last forever. Over time, delicate pigments fade, restoration or conservation attempts may go wrong, or objects of art may be attacked, such as the attack by Laszlo Toth on Michelangelo's Pieta or the more recent destruction of theBuddhas of Bamiyan by the Taliban in Afghanistan in 2001.

While it may not be able to prevent vandalism, the Nanoforart project has taken on the task of appling nanotechnology to preserving and conserving works of art:

The main objective of the NANOFORART proposal is the development and experimentation of new nano-materials and responsive systems for the conservation and preservation of movable and immovable artworks.

While the progress in material science has generated sophisticated nanostructured materials, conservation of cultural heritage is still mainly based on traditional methods and conventional materials that often lack the necessary compatibility with the original artworks and a durable performance in responding to the changes of natural environment and man-made activities.

The main challenge of NANOFORART is the combination of sophisticated functional materials arising from the recent developments in nano-science/technology with innovative techniques in the restoration and preventive conservation of works of art, with unprecedented efficiency.

An earlier posting on this site discussed the use of nanomaterials to preserve and conserve artifacts found at archealogical excavation sites, the use of such nanomaterials to preserve works of art is a new development in this area.

Many of the greatest works of art have lasted for hundreds of years and have become part of the cultural heritage of all humanity. For example, Van Gogh's many paintings of Sunflowers, one of which is at the top of this posting, are as well known and admired in Asia or South America as they are in Europe. Let us hope that the use of nanomaterials can lead to the Mona Lisa. smiling her enigmatic smile for another 500 years.

First-to-File Patent System Arrives March 16, 2013

Martin Miller — Fri, 22 Feb 2013 11:20:16 -0500

With significant changes to law governing how the U.S. grants patents taking effect next month, Porter Wright recommends that all clients consider filing any contemplated patent applications by March 15. This includes filing non-provisional patent applications, and in some cases Patent Cooperation Treaty (PCT) patent applications, that are based upon any provisional or non-U.S. patent application filed since March 2012. Though there are some exceptions to this advice, waiting until after March 15 may be problematic.

In brief: For patent applications having any claim with an effective filing date after March 15, it will no longer be possible to overcome prior art by showing an earlier date of invention. Thus, the prior art for purposes of patentability will include: 1) third-party public disclosures of any kind, anywhere in the world, prior to your effective filing date; and 2) issued U.S. patents and published U.S. or PCT patent applications that were effectively filed before your effective filing date. In addition to not being able to "swear behind" a prior art reference by proving an earlier date of invention, the prior art date for patents and published patent applications may be as much as 18 months earlier than under current law because of foreign priority claims.

It is also important to note that inventors will not lose the benefit of any earlier provisional or non-U.S. patent application should they wait until after March 15 to file. Any claims that are adequately supported in the earlier filing will be entitled to that earlier filing date for purposes of patentability. However, if even one claim in the post-March 15 application is new (i.e., includes subject matter not disclosed in your earlier application) the new first-to-file rules will apply to all claims — and there will be no way to alter this scenario through actions such as deleting claims containing the new subject matter.

A Porter Wright Law Alert describes these patent law changes in greater detail.

New Chairman of House Committee on Science, Space and Technology

Robert Oszakiewski — Mon, 14 Jan 2013 15:35:32 -0500

The 113th Congress has begun it's first session and, as is the usual procedure at the start of a new Congress, new chairpersons have been selected for most of the House and Senate Committees. Among these new chairs is Representive Lamar S. Smith (R-TX-21st), Chair of the House Committee on Science, Space and Technology. Much of the legislation that has affected nanoindustry and the nanotech community has passed before this committee.

Rep. Smith as long been a supporter of the nanotech community, co-sponsoring such legislation as the "National Nanotechnology Initiative Amendments Act of 2009". and is a senior member of the Congressional Nanotechnology Caucus.

Along with a new committee chairperson, the subcommittees have also gotten new chairs. The Subcommittee on Research and Education, which "has legislative jurisdiction and general oversight and investigative authority on all matters relating to science policy and science education including: . . . research, development, and demonstration relating to nanoscience, nanoengineering, and nanotechnology", is now chaired by Rep. Larry Bucshon (R-IN-8th). Rep. Bucshon, first elected in the 2010 midterm elections, has not sponsored or co-sponsored much legislation and his positions on nanotechnology and nanoindustry are as yet unknown.

Legislation affecting either nanoindustry or the larger nanotech community has yet to be introduced in either the House or the Senate; such legislation may benefit from having Rep. Smith as Committee Chairperson.

Silver Nanoparticles: NIOSH Seeks Information and Comment

Robert Oszakiewski — Wed, 19 Dec 2012 11:55:02 -0500

Today's Federal Register carries a notice from the National Institute for Occupational Health and Safety (NIOSH) requesting information and comments regarding silver nanoparticles. NIOSH

has initiated an evaluation of the scientific data on silver nanoparticles
(AgNPs) to ascertain the potential health risks to workers and to
identify gaps in knowledge so that appropriate laboratory and field
research studies can be conducted. . . .

. . . gathering data to determine whether a
health risk to workers may exist from exposure to AgNPs and if specific
risk management guidance is needed to prevent exposure. . . .

Information is particularly needed for determining the relevance
of bile duct hyperplasia and hepatocellular necrosis observed in AgNP
exposed rats, as well as information on: (1) Sources of AgNP exposure,
(2) factors that influence worker's exposure, (3) in-place exposure
control measures (e.g., engineering controls) and work practices that
are effective in reducing worker exposures, and (4) appropriate
measurement methods and exposure metrics for characterizing workplace
exposures. . . .

Examples of requested
information include the following:
    (1) Identification of industries or occupations in which exposures
to AgNPs may occur.
    (2) Trends in the production and use of AgNPs.
    (3) Description of work tasks and scenarios with a potential for
exposure to AgNPs.
    (4) Workplace exposure measurement data in various types of
industries and jobs.
    (5) Case reports or other health information demonstrating
potential health effects in workers exposed to AgNPs.
    (6) Research findings from in vitro and in vivo toxicity studies,
including physical-chemical characterization of AgNPs.
    (7) Information on control measures (e.g., engineering controls,
work practices, PPE) being taken to minimize worker exposure to AgNPs.
    (8) Information on measurement methods and exposure metrics that
can be used to quantify worker exposure to AgNPs including information
on the limitations of those methods in quantifying exposures?

Information submitted my include "published and unpublished reports and research findings".

"All information received in response to this notice must include the agency name and docket number (CDC-2012-0014; NIOSH-260)". and may be submitted either online via Regulations.gov - instructions on how to submit are available on the website - or by mail to

NIOSH Docket Office,

Robert A. Taft Laboratories,
MS-C34

4676 Columbia Parkway, Cincinnati, OH 45226.

Comments and information submitted will be posted to the docket on Regulations.gov. The deadline for submitting either comments or information is February 19, 2013.

NIOSH has compiled a listing of relevant publications regarding AgNPS, "Evaluation of the Scientific Data on Silver Nanoparticles (AgNPS)" and will be posting that listing to the docket on Regulations.gov. Several studies of silver nanoparticles are listed as references in the notice and presumable compose the bulk of the listing. This posting will be updated when the list is available.

For further information please contact

Ralph Zumwalde, NIOSH,

MS-C14,

Robert A. Taft Laboratories,

4676 Columbia Parkway, Cincinnati, Ohio 45226,
telephone (513) 533-8320

or Eileen Kuempel, telephone (513) 533-8363

UPDATE:

"Evaluation of the Scientific Data on Silver Nanoparticles (AgNPS)" has been posted to the docket on Regulations.gov.

'Tis the Season For Holiday Workplace Issues

Robert Oszakiewski — Mon, 17 Dec 2012 11:44:18 -0500

It's that time of year – crowded shopping centers, festive gatherings, and time with family both near and far.

For employers the holidays create increased risk of employer liability – which may result in legal problems for those that are unprepared. Members of our Labor and Employment practice publish the Employer Law Report, which today posted a timely eBook compiling the top five holiday headaches for employers. As many may find the topic of interest, we wanted to take a moment and share it with our readers as well.

The ebook complies the following posts:

·         Avoiding Holiday Party Liability When the Office Santa Tries to Teach His Employees a Few"Reindeer Games"

·         Being Inclusive Without Being A Grinch

·         "Holiday Attire" Does Not Include "Beer Goggles"

·         Holiday Pay and How Not to Get Scrooged by The FLSA

·         What if Santa Was the One Who Got Run Over By a Reindeer

·         Three FMLA Stocking Stuffers: How to Avoid a Big Lump of Coal (bonus)

New study of nanoparticle skin penetration

Robert Oszakiewski — Tue, 16 Oct 2012 14:14:00 -0500

As engineered nanoparticles (ENPs) become increasingly common in consumer products and the environment, concern over their possible effects on human health also rises. There is concern over the possible penetration of human skin by ENPs. "However, the evidence whether nanoparticles can infiltrate into underlying tissues is conflicting . . . clarification of the issue is essential. . .."

With this in mind, Christopher. S.J. Campbell of Mango Business Solutions, L. Roderigo Contreras-Rojas, M. Begona Delgado-Charro, and Richard H. Guy, of the University of Bath Department of Pharmacy & Pharmacology have recently published a study "Objective assessment of nanoparticle disposition in mammalian skin after topical exposure" in the Journal of Controlled Release discussin the results of their attempts to measure the extent and depth that ENPs are able to penetrate the skin, in the case of this study the specially cleaned and prepared skin of a pig.

Following exposure to ENPs, the skin samples were examined using a laser scanning confocal microscope. The reported results indicate that ENPs did not fully penetrate the skin, but only penetrated where a crease or a crack in the skin was present.

The authors note and warn about the limited nature of their research:

It should be emphasised that this research has clearly not been able to make a systematic evaluation of nanoparticle disposition on the skin for the entire spectrum of particle properties, including shape and charge. . . .the observations and their analysis cannot explain, with any degree of certainty, why others have reported nanoparticle uptake into living skin layers following their topical application . . . . While speculative alternatives might be proposed, such as accidental contamination on sectioning, or invisible flaws in skin integrity (across which, for example, a very small quantum dot of a few nanometres diameter might be able to travel), complete understanding will only be possible with further, scrupulously controlled experiments coupled with objective data analysis and interpretation.

According to a recent article in the Sydney Morning Herald, the study has been criticized by Dr. Gregory Crocetti of Friends of the Earth Australia and Professor Brian Gulson of the Department of Environment and Geography at Macquarie University.

The study is not the definative work in this area and the authors have noted its limitations; it is one more contribution to a growing body of scientific literature on the subject of nanoparticles and human health.

Nano.gov announces webinar for 09/20/2012

Robert Oszakiewski — Mon, 17 Sep 2012 14:06:38 -0500

In a notice that appeared in last Thursday's Federal Register, the National Nanotechnology Coordination Office (NNCO), announced that it would be hosting a webinar on Nano.gov on Thursday 09/20/2012, from 12:15 until 1PM. " NNCO is seeking public comment and recommendations on potential updates to, improvements on, and opportunities for public engagement through Nano.gov."

The webinar will consist of two parts. Part 1, the first 20 minutes of the webinar, will be spent on short presentations by the moderator and four panelists:

Moderator:
Marlowe Epstein-Newman, National Nanotechnology Coordination Office (NNCO)—Marlowe is the Communications Director at NNCO and was the Project Manager for the first Nano.gov redesign in 2011. She manages the content on Nano.gov as well as the NNI’s social media presence.





Panelists:
Carl Batt, Cornell University—Carl is a Food Science professor with ties to National Science Foundation as a regularly consulted expert. Carl recently collaborated with the National Nanotechnology Infrastructure Network and Walt Disney World to create a permanent nanotechnology exhibit at Epcot Center.

Joshua A, Chamot, National Science Foundation (NSF)—Josh is a public affairs specialist in NSF's Office of Legislative and Public Affairs. As a seasoned public affairs professional, he provides a unique perspective on media, public relations, and outreach tactics from a Federal Government perspective. Josh works in a variety of media to bring science stories to the public.

Mary Ann Latko, American Industrial Hygiene Association(AIHA)—Mary Ann is a Managing Director at AIHA. She represents workers across manufacturing sectors and is well-versed in enivironment, health, and safety (EHS) and regulatory issues, often working closely with the National Institute for Occupational Safety and Health (NIOSH).

Nazhin Beiramee, OMNI Studios—Nazhin is a web designer who has worked on Nano.gov as well as other .govs including the the Food and Drug Administration, the National Institutes of Health, and the National Cancer Institute.

The remaining portion of the webinar will be a Q&A session, with questions submitted by the audience. Questions and comments should be focused on

How is Nano.gov useful to you and your stakeholders/colleagues/peers?

What do you like on Nano.gov? Which pages are most useful to you? Why?

What would you like to see improved? Are there pages you don’t understand? Confusing information? Poor layout? Difficult to use?

Are there pages that you feel are missing from Nano.gov? What other types of pages would you like to see? What information would you like to find on Nano.gov that isn’t currently there?

Are there similar websites that present information in a way that you find more useful, exciting, attractive or user-friendly?

The NNCO will begin accepting questions and comments via email (webinar@nnco.nano.gov) and Twitter (@NNInanonews) 24 hours prior to the event, until the close of the webinar at 1pm on September 20. These will be read and addressed during the live event. The NNCO reserves the right to group similar questions and to address only those questions and comments germane to the topic.

Registration for the webinar is required and is now open.

Rice University at 100: Congressional Remarks

Robert Oszakiewski — Mon, 16 Jul 2012 14:50:12 -0500

Rice University, located in the city of Houston, Texas, is observing it's 100th anniversary in October of this year, and many of the Texan members of the US House of Representives have made congratulatory remarks on the floor of the House or have inserted them in the Congressional Record Extension of Remarks.In their remarks, Rep. John Culbertson (R-7th) and Rep. K. Michael Conway (R-17th) paid particular attention to Rice's role in the nanotech world. Their remarks are below.

RICE UNIVERSITY'S 100TH ANNIVERSARY -- (House of Representatives - July 11, 2012) [Page: H4790]

   (Mr. CULBERSON asked and was given permission to address the House for 1 minute and to revise and extend his remarks.)

   Mr. CULBERSON. Madam Speaker, I have the singular privilege of representing Rice University, and I join my colleagues from Houston in recognizing and congratulating them on their 100th anniversary this year.

   Rice has consistently been ranked as one of the Nation's greatest universities and recognized by U.S. News & World Report as among the Nation's top 20 universities. And they've consistently ranked in the top 50 universities in the world.

   Rice University researchers are pioneers in a broad spectrum of fields, including space, energy, and my personal passion, nanotechnology. Nanotechnology is an absolute game-changer, revolutionizing everything that we will touch and see in the 21st century. Rice University is the birthplace of nanotechnology research.

   Nanotechnology holds incredible potential for everything from curing cancer to improving the storage and transmission of electricity and moving electricity in ways that we cannot even imagine today, allowing us to miniaturize devices. Multistage nanoparticles will allow the delivery of cancer-curing drugs to individual structures within cells, allowing scientists to identify diseases at the cellular level, things that could not have been possible without the groundbreaking work at Rice University.

   I congratulate them on their 100th anniversary today.
RICE UNIVERSITY 100TH BIRTHDAY -- HON. K. MICHAEL CONAWAY (Extensions of Remarks - July 11, 2012) [Page: E1235]

HON. K. MICHAEL CONAWAY
OF TEXASIN THE HOUSE OF REPRESENTATIVESWednesday, July 11, 2012

Mr. CONAWAY. Mr. Speaker, I rise today to congratulate Rice University on its 100th birthday. For over a century it has stood as one of the premier educational institutions in the world.

Over the past 100 years, Rice University's name has come to be synonymous with excellence. The institution consistently ranks among the top 20 national universities in the U.S. News & World Report and holds many other marks of excellence.

For example, in 2010 Rice University was ranked No. 1 worldwide in materials science research. In 2011, the Carnegie Foundation gave the university top classifications for ``very high research activity'' and ``comprehensive doctoral program''.

While this is an amazing accomplishment, Rice's work is more than just a statistic--it has changed the world we live in. The research performed by the university has proved groundbreaking on several fronts, most notably the discovery of ``buckyballs.'' The discovery launched the field of Nanotechnology which has led directly to advances many fields, including medicine, technology, energy, defense, and transportation. Nanotechnology is already playing a powerful role in the lives of Americans, from its capacity to help find cures to deadly diseases to reducing the cost and extending the lifespan of consumer products like clothes and cars.

Rice's School of Business, Architecture, Engineering, Social Sciences, Music, Humanities, Institute of Public Policy, and the Alliance of Technology and Entrepreneurship all hold similar national standing.

Not only is Rice University a heavyweight contender in academic and research fields, the university also maintains a noteworthy athletic department. For 17 consecutive years, Rice has produced a NCAA conference championship team--another outstanding accomplishment.

Again, congratulations to Rice University on its 100th birthday. Rice University's devoted faculty and student body have continually endeavored for excellence, and as a result Texans, Americans, and people all over our world have benefited.

Affordable Care Act: The Supreme Court Issues it's Opinion

Robert Oszakiewski — Thu, 28 Jun 2012 13:56:30 -0500

As many readers of this blog are by now aware, the Supreme Court today issued its much anticipated opinion in National Federation of Business et al v. Sebelius, regarding the constitutionality of the Patient Protection and Affordable Health Care Act (PL 111-148), more commonly refered to as "Obamacare". Because of the importance of this decision, we're attaching a link to another blog site maintained by Porter Wright Morris & Arthur LLP, "Employee Benefits Law Report", and to an entry , "Health Care Reform Survives Supreme Court Scrutiny - But Not Entirely Intact", authored by Rich McHugh, a partner in the Porter Wright DC office. Rich's practice focuses on employee benefits. A link to the decision is embedded within the article.

Results of a pilot study on non-human primates and quantum dots

Robert Oszakiewski — Fri, 15 Jun 2012 15:28:19 -0500

Several studies of possible toxic effects of quantum dots on humans have been done using cell cultures in petri dishes or rodents, usually white lab rats. But lab rats are related to humans only in that both are mammals.

In a recently published letter in Nature Nanotechnology,"A pilot study in non-human primates shows no adverse response to intravenous injection of quantum dots", published online 05/20/2012, Ling Ye and other authors based at PLA General Hospital in Beijing, SUNY-Buffalo, Nanyang Technological University, and Changchun University of Science and Technology, report the results of experiments where quantum dots where injected into male rhesus monkeys. Rhesus monkeys were chosen for this experiment since they are genetically and physiologically closer to humans than rodents and are less endangered than chimpanzees.

The authors report that the rhesus monkeys did not exhibit any ill effects from the injections:

A complete blood count (cbc) was performed at regular intervals and the results did not suggest any acute toxicity.

After 90 days, the study did find that quantum dots had accumulated in the liver, spleen, and kidneys and in lesser amounts in the heart, lungs, and other organs. Examinations of tissues from these organs found no abnormalities.

In conclusion, rhesus macaques intravenously injected with ~ 25 mg of a cadmium based quantum dot formulation survived without any evidence of toxicity. All measured biochemical markers were in the normal range. . . .However, given the persistence of elevated cadmium and selenium levels in organs after three months, longer term studies will be required to determine the ultimate fate of these heavy metals and any ill effects arising due to their presence. All data obtained in this pilot study suggest that the phospholipid micelle encapsulated quantum dot formulation has very low tosicity on the timescale considered. This suggests a potential role for quantum dots in human clinical applications, such as image guided surgery for tumour removal, where the advantages provided for quantum dots can outweigh the potential risk associated with accumulation of their constituent elements in the body.

Heat and Nanoparticles in Water

Robert Oszakiewski — Wed, 13 Jun 2012 13:22:27 -0500

As nanoparticles become more commonly used in everyday products it becomes increasingly important to understand " nanoparticle aggregation in the aqueous environment . . . for assessing the fate, transport and toxicity of nanomaterials". In an effort to increase the body of scientific knowledge in this area, Dongxu Zhou, Samuel W. Bennett, and Arturo A. Keller, all of the University of California Santa Barbara Bren School of Environmental Science and Management, in an article published on the PLOS One website "report for the first time . . . temperature variations can cause either agglomeration or disagglomeration . . . depending on the heating and cooling paths. This finding is very relevant . . . , since it indicates that ambient temperature change, constantly occurring in open waters, can alter nanoparticle mobility." Following studies cited in the article's references, the authors define aggregates as "particle clusters bound by irreversible chemical bonds", while agglomerates are "clusters" held together by weak physical interactions. " Once released in the environment, nanoparticles will very likely exist as agglomerated aggregates, i.e. aggregate clusters that have weaker bonds between them. "

In experiments on clusters of three types of metallic oxides - titanium dioxide, zinc oxide, and cerium oxide - lead the authors to conclude

. . . that in open water these soft (weakly bonded) agglomerates can be disagglomerated by common environmental stimuli, such as exposure to sunlight or an increase in temperature from diurnal variations. Although not evaluated, it is likely that mechanical shocks may also result in temporary disagglomeration. The released aggregates can be much more mobile and bioavailable while the stimuli is present. Although in our experimental setting we observe reagglomeration once the stimuli are removed, in the environment it may be that the probability of interacting with another nanoparticle aggregate is much lower. . . . The effect of disagglomeration on toxicity has not been considered, or systematically evaluated. This phenomenon warrants attention since it is likely that these metal oxide nanoparticles will experience these natural stimuli during their transport in the environment.

S. 3187, "Food and Drug Administration Safety and Innovation Act" passes in Senate

Robert Oszakiewski — Tue, 12 Jun 2012 14:50:44 -0500

Prior to adjourning for the Memorial Say recess, the Senate, on 05/24/2012, by a vote of 96-1, passed S. 3187, the "Food and Drug Administration Safety and Innovation Act", " To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes", after previously adopting an amendment in the nature of a substitute- an amendment in the nature of a substitute strips all of the language of a bill following the enacting clause and replaces it with new language - offered by Senator Tom Harkin (D-Iowa). Included as part of the language of the amendment was Title XI - Other Provisions, Subtitle C- Misc. Provisions, Section 1133, "Nanotechnology Regulatory Science Program":

SEC. 1133. NANOTECHNOLOGY REGULATORY SCIENCE PROGRAM.

(a) In General- Chapter X (21 U.S.C. 391 et seq.) is amended by adding at the end the following:

`SEC. 1013. NANOTECHNOLOGY REGULATORY SCIENCE PROGRAM.

`(a) In General- Not later than 180 days after the date of enactment of the Food and Drug Administration Safety and Innovation Act, the Secretary, in consultation as appropriate with the Secretary of Agriculture, shall establish within the Food and Drug Administration a Nanotechnology Regulatory Science Program (referred to in this section as the `program') to enhance scientific knowledge regarding nanomaterials included or intended for inclusion in products regulated under this Act or other statutes administered by the Food and Drug Administration, to address issues relevant to the regulation of those products, including the potential toxicology of such materials, the effects of such materials on biological systems, and interaction of such materials with biological systems.

`(b) Program Purposes- The purposes of the program established under subsection (a) may include--

`(1) assessing scientific literature and data on general nanomaterials interactions with biological systems and on specific nanomaterials of concern to the Food and Drug Administration;

`(2) in cooperation with other Federal agencies, developing and organizing information using databases and models that will facilitate the identification of generalized principles and characteristics regarding the behavior of classes of nanomaterials with biological systems;

`(3) promoting Food and Drug Administration programs and participate in collaborative efforts, to further the understanding of the science of novel properties of nanomaterials that might contribute to toxicity;

(4) promoting and participating in collaborative efforts to further the understanding of measurement and detection methods for nanomaterials;

(5) collecting, synthesizing, interpreting, and disseminating scientific information and data related to the interactions of nanomaterials with biological systems;

(6) building scientific expertise on nanomaterials within the Food and Drug Administration, including field and laboratory expertise, for monitoring the production and presence of nanomaterials in domestic and imported products regulated under this Act;

(7) ensuring ongoing training, as well as dissemination of new information within the centers of the Food and Drug Administration, and more broadly across the Food and Drug Administration, to ensure timely, informed consideration of the most current science pertaining to nanomaterials;

(8) encouraging the Food and Drug Administration to participate in international and national consensus standards activities pertaining to nanomaterials; and

(9) carrying out other activities that the Secretary determines are necessary and consistent with the purposes described in paragraphs (1) through (8).

(c) Program Administration-

(1) DESIGNATED INDIVIDUAL- In carrying out the program under this section, the Secretary, acting through the Commissioner of Food and Drugs, may designate an appropriately qualified individual who shall supervise the planning, management, and coordination of the program.

(2) DUTIES- The duties of the individual designated under paragraph (1) may include--

(A) developing a detailed strategic plan for achieving specific short- and long-term technical goals for the program;

(B) coordinating and integrating the strategic plan with activities by the Food and Drug Administration and other departments and agencies participating in the National Nanotechnology Initiative; and

(C) developing Food and Drug Administration programs, contracts, memoranda of agreement, joint funding agreements, and other cooperative arrangements necessary for meeting the long-term challenges and achieving the specific technical goals of the program.

(d) Report- Not later than March 15, 2015, the Secretary shall publish on the Internet Web site of the Food and Drug Administration a report on the program carried out under this section. Such report shall include--

(1) a review of the specific short- and long-term goals of the program;

(2) an assessment of current and proposed funding levels for the program, including an assessment of the adequacy of such funding levels to support program activities; and

(3) a review of the coordination of activities under the program with other departments and agencies participating in the National Nanotechnology Initiative.

(e) Effect of Section- Nothing in this section shall affect the authority of the Secretary under any other provision of this Act or other statutes administered by the Food and Drug Administration.'.

(b) Effective Date; Sunset- The Nanotechnology Regulatory Science Program authorized under section 1013 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)) shall take effect on October 1, 2012, or the date of the enactment of this Act, whichever is later. Such Program shall cease to be effective October 1, 2017.

Except for some stylistic changes and the removal of a subparagraph on appropriations, Sect. 1133 is the language of S. 1662 , the "Nanotechnology Regulatory Science Act of 2011", introduced on 10/06/2011 by Senator Mark Pryor (D-Arkansas) andSenator Ben Cardin (D-Maryland) and subsequently assigned to the Senate Committee on Health, Education, Labor and Pensions . No hearings were ever held on the bill nor was it ever reported out of committee.

During floor debates on S. 3187, Senator Cardin urged his felllow Senators to support and pass S. 3187, focusing on the language of Sec. 1134:

Mr. CARDIN. Madam President, I rise to discuss the FDA Safety and Innovation Act, the bill now under consideration here in the Senate.. . .

I express my appreciation to Senator Pryor for his leadership on nanotechnology. I am pleased to join him in this effort and am hopeful that the language we have sponsored can be included in this bill.

   Nanotechnology has become increasingly indispensible in our daily lives--everything from cellphones and MP3 players, to packaging of our snack foods, to cancer treatments in development employ the use of nanotechnology.

   As this burgeoning technology continues to power more of our consumer products and drive job creation in America, it is essential that we fully assess, understand, and address any risks that it may pose to safety, public health and our environment.

   By soundly assessing the safety of nanotechnology and developing best practices, the Nanotechnology Regulatory Science Act of 2011 will further job creation, public safety and growth in the industry.

   Our bill would establish a program within the FDA to assess the health and safety implications of using nanotechnology in everyday products, and develop best practices for companies using nanotechnology. This new program would bring more highly-skilled research jobs to Maryland.

   FDA's laboratories and research facilities at its consolidated headquarters are ideally suited to conduct the scientific studies required under the bill.

   The USDA's Beltsville Agricultural Research Center, BARC, is similarly equipped to provide innovative scientific technology, training, methods development, and technical expertise to improve public health. . . . .

I also will mention one other issue: nanotechnology. I congratulate Senator Pryor for his leadership in this area. Programs at FDA to access health safety facts and using nanotechnology in everyday products is something we need to do. This legislation advances that. I point out that I am proud that the lab facilities at the FDA are fully capable of dealing with the challenges presented by nanotechnology. This legislation acknowledges that.

   We also, in Maryland, are proud of the Beltsville Agricultural Research Center, which will advance nanotechnology and the impact it has on everyday products and safety. Those issues will be addressed also by the underlying bill. We very much appreciate the leadership of the committee.

On 05/30/2012, the House, under a suspension of the rules, passed H.R. 5651, the "Food and Drug Administration Reform Act of 2012". H.R. 5651 differs substantially from S. 3187; among these differences, H.R. 5651 contains no provisions regarding nanotechnology. These differences in language mean that a Conference Committee will be appointed to write a version of the two bills that should be adopted by both the Senate and the House. Although such a committee has not been appointed as of this date, one is expected to be formed soon. As with other legislation affecting nanotechnology we will monitor S.3187 and H.R. 5651 and update this site accordingly.

Naturally produced nanoparticles and food

Robert Oszakiewski — Fri, 01 Jun 2012 13:18:55 -0500

The possible presence of nanoparticles in food has, for the last few years, been a controversial topic, focusing usually on the possible toxic effects of manufactured carbon nanoparticles (MCNs) on human health. A recently published article by members of the Departments of Chemistry and Biotechnology at the Indian Institute of Technology Guwahati, "Presence of Amorphous Carbon Nanoparticles in Food Caramels", looked at a different aspect of the contoversy, naturally produced carbon nanoparticles. As the authors point out, naturally produced carbon nanoparticles (CNPs) have possibly been present in various types of food for thousands of years and offer the possibility of being used as vehicles for the delivery of medications within the human body.

In their study, Prof. Arun Chattopadhyay and colleagues tested "regular carbohydrate based food caramels, such as bread, jaggery, corn flakes, and biscuits . . . . where the preparation of food maily involves heating the starting ingredients in the absence of water, leading to the formation of caramels", for the presence of CNPs, which were detected. The CNPs were not of a uniform size, as would be expected with MCNs but were of various sizes, "indicating temperature dependent formation". More importantly

These caramels containing CNPs have been consumed by human beings with no know toxicity and thus it can be considered to have no or minimum risk on human health and be used as a safe nanomaterial.

All of these are foods that, as the authors note, "have been consumed by humans for centuries, and thus they can be considered as safe" for use in "various biological applications", including, as mentioned above, the delivery of medications to specific sites within the human body, such as tumors,

Progress in the Commercialization of Graphene

Robert Oszakiewski — Tue, 29 May 2012 14:16:03 -0500

European Plastics News posted an article on it's site last week,("Graphene developers seek routes out of the lab"), focusing on challenges to and progress in the commercialization of graphene, specifically its "potential as a mutlifunctional reinforcement in composites".

Among the challenges the article raises are:

1) Entangling of 3D carbon nanotubes (CNTS) bundles

2) Individual graphite sheets restacking themselves

3) Handling of such shets during transportation to processing facilities

4) Reduction of costs of production and transportation

5) A need to develop standard operating procedures for potential health hazards

While these challenges may seem daunting, the success of three companies - Vorbeck Materials of Maryland,Cabot Corporation of Massachusetts, and Thomas Swan & Co., based in the United Kingdom - are highlighted.

The article also discusses the ongoing support of the European Commission (EC) and the UK's government of research in graphene and how to commercialize it.:

The European Commission is planning to channel €1bn over 10 years into co-ordinated graphene research and commercialisation. The UK government has announced it wants to spend another £50m (€60.7m) to keep the UK at the forefront of graphene research, with the University of Manchester set to host a national institute of graphene research. Commercialisation of graphene by this route could arrive by late 2012.

Converted in US dollars, the EC will be spending $1.278 billion and the UK $78.153 million.

An Interview with Senator Ron Wyden

Robert Oszakiewski — Mon, 07 May 2012 15:36:50 -0500

The New Haven Independent regularly covers the nanotech field, from the latest experiment in using nanoparticles to deliver medications more efficently to discussions of how nanoindustry will affect the national and regional economies. Recently the New Haven Independent posted an edited transcript of an internview with Senator Ron Wyden (D-OR), a long time advocate of Nanotech research and Nanoindustry in the US Senate and one of the Co-chairs of the Congressional Nanotechnology Caucus.

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.

Nanotechnology and "Soft Law"

Robert Oszakiewski — Tue, 03 Apr 2012 14:21:48 -0500

Noting that nanotechnology and nanoindustries have emerged during a period when both the power and ability of government agencies, both on the Federal and State levels, to regulate commerce in all of it's myriad forms has come under debate and "renewed interest in regulatory reform" and is being "replaced by new governance approaches seeking to transform regulation from [an] agency-centric excercise in setting incentives to a collarborative undertaking by actors from multiple segments of society" Professor Timothy F. Malloy of the UCLA School of Law, in a short essay "Soft Law and Nanotechnology: A Functional Perspective", examines"soft law" in the regulation of nanoindustry. "Soft law", in this study, rises from multiple sources, "established standards of behavior and . . . is not legally binding".

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.

Women in Europe for a Common Future Issues Position Paper: Nano the Great Unknown

Robert Oszakiewski — Mon, 02 Apr 2012 11:50:57 -0500

Women in Europe for a Common Future, (WECF) founded in the Netherlands in 1994, " is a network of 100 member organizations and individual members who share a common concern to promote a healthy environment for all, strengthen the role of women and promote a gender and rights based approach in environment and sustainable development policy and implementation." Recently, WECF issued a position paper, "Nano: The Great Unknown". WECF takes the position that "Neither the industry nor public authorities have shown adequate leadership and willingness in addressing" the possible toxic effects of manufactured nanomaterials (MNMs) on humans and the environment.

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.

The EPA Inspector General's Report

Robert Oszakiewski — Tue, 27 Mar 2012 13:20:05 -0500

The task of the Inspectors General of Federal agencies is to examine "all actions of a government agency or military organization. Conducting audits and investigations, either independently or in response to reports of wrongdoing, the OIG ensures that the agency's operations are in compliance with the law and general established policies of the government. Audits conducted by the OIG are intended to ensure the effectiveness of security procedures, or to discover the possibility of misconduct, waste, fraud, theft, or certain types of criminal activity by individuals or groups related to the agency's operation."

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.

Guide to Responsible Nano-Business

Robert Oszakiewski — Tue, 20 Mar 2012 12:03:59 -0500

ObservatoryNANO recently published a "Guide to Responsible Nano-Business", a brief report written for an audience of "Medium sized companies involved in the development, processing, production, or trade of nanotechnology-enabled materials, components, or applications".

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.

National Science Foundation 2013 Budget Request

Robert Oszakiewski — Mon, 12 Mar 2012 14:16:19 -0500

As part of the Fiscal Year (FY) 2013 budget appropriations process, Dr. Subra Suresh, Director of the National Science Foundation (NSF), appeared before the House Committee on Appropriations Subcommittee on Commerce, Justice, Science, and Related Agencies on Tuesday, 03/06/2012, to present and respond to the subcommittee members questions about the NSF's proposed 2013 budget.

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.