Tag Archives: FP 7

Heart of stone

Researchers in Europe do not want to find out what would Europe look like without its stone castles, Stonehenge, Coliseum, cathedrals, and other monumental stone structures, and have found a possible solution to the problem of deterioration according to an Oct. 20, 2014 news item on Nanowerk,

Castles and cathedrals, statues and spires… Europe’s built environment would not be the same without these witnesses of centuries past. But, eventually, even the hardest stone will crumble. EU-funded researchers have developed innovative nanomaterials to improve the preservation of our architectural heritage.

“Our objective,” says Professor Gerald Ziegenbalg of IBZ Salzchemie, “was to find new possibilities to consolidate stone and mortar, especially in historical buildings.” The products available at the time, he adds, didn’t meet the full range of requirements, and some could actually damage the artefacts they were meant to preserve. Alternatives compatible with the original materials were needed.

A July 9, 2014 European Commission press release, which originated the news item, provides more details about this project (Note: A link has been removed),

 Ziegenbalg was the coordinator of the Stonecore project, which rose to this monumental challenge within a mere three years. It developed and commercialised a new type of material that penetrates right into the stone, protecting it without any risk of damage or harmful residues. The team also invented new ways to assess damage to stone and refined a number of existing techniques.

The concept behind the new material developed by the Stonecore partners is ingenious. It involves lime nanoparticles suspended in alcohol, a substance that evaporates completely upon exposure to air. The nanoparticles then react with carbon dioxide in the atmosphere to form limestone.

This innovation is on the market under the brand name CaLoSil. It is available in various consistencies – liquids and pastes – and in a number of formulations based on different types of alcohol, as well as with added filler materials such as marble. The product is applied by dipping, spraying or injection into the stone.

Beyond its use as a consolidant, CaLoSil can also be used to clean stone and mortar, as it helps to treat fungus and algae. The dehydrating effect of the alcohol and the acidity of the lime destroy the cells, and the growth can then be washed off. This method, says Ziegenbalg, is more effective than conventional chemical or mechanical approaches, and it does not damage the stone.

Limestone face-lifts

The partners tested their new product in a number of locations across Europe, on a wide variety of materials exposed to very different conditions. Together, they rejuvenated statues and sculptures, saved features in cathedrals and citadels, and treated materials as diverse as sandstone, marble and tuff.

The opportunity to access such a wide variety of sites, says Ziegenbalg, was one of the many advantages of working with partners from several countries. It pre-empted the risk of developing a product that was too narrowly focused on a specific application.

Inside the heart of stone

A number of techniques enable conservation teams to assess the state of the objects in their care. To obtain a clearer picture of deeper damage, Stonecore improved existing approaches involving ultrasound, developing a new device. The project also pioneered a new technique based on ground-penetrating radar, which one partner is now offering as a commercial service.

The team also developed an innovative micro-drilling tool and refined an existing technique for measuring the water uptake of stone.

A further innovation is a new technique to measure surface degradation. For this so-called “peeling test”, a length of adhesive tape is affixed to the object. The weight of the particles that come off with the tape when it is removed indicate how likely the stone is to degrade.

Carving out solutions

The partners’ achievements have not gone unnoticed. In 2013, Stonecore was shortlisted along with 10 other projects for the annual EuroNanoForum’s Best Project Award.

Ziegenbalg attributes the team’s success mainly to the partners’ wide range of complementary expertise, and to their dedication. “The participating small and medium-sized enterprises were extremely active,” he says. “They were highly motivated to handle the more practical work, while the universities supported them with the necessary research input.”

While it’s not clear from this press release or the Stonecore website, it appears this project has run its course as part of European Union’s Framework Programme 7.

Tackling antibiotic resistance with inhalable nanotherapeutics

A June 25, 2014 news item on Nanowerk highlights PneumoNP a new European Union ‘theragnostic’ research project (Note: Links have been removed) ,

A new research project (PneumoNP) is aimed at tackling antibiotic resistance in respiratory tract infections via the use of inhalable nanotherapeutic compounds. Funded under the FP7 programme by the European Commission, the 4-year long PneumoNP project brings together top research institutes, universities, clinicians and enterprises from 6 EU member states. This novel collaboration will contribute to answer the call of the World Health Organization (WHO), who recently released an alarming report on the global threat of antibiotic resistance.

The project will develop an innovative solution to antibiotic resistance by coupling new antibiotics to inhalable carrier molecules, resulting in more efficient targeting of antibiotics to infection-causing bacteria present in the respiratory tract.

An April 30, 2014 WHO news release details the level of antibiotic resistance,

New WHO report provides the most comprehensive picture of antibiotic resistance to date, with data from 114 countries

A new report by WHO–its first to look at antimicrobial resistance, including antibiotic resistance, globally–reveals that this serious threat is no longer a prediction for the future, it is happening right now in every region of the world and has the potential to affect anyone, of any age, in any country. Antibiotic resistance–when bacteria change so antibiotics no longer work in people who need them to treat infections–is now a major threat to public health.

The report, “Antimicrobial resistance: global report on surveillance”, notes that resistance is occurring across many different infectious agents but the report focuses on antibiotic resistance in seven different bacteria responsible for common, serious diseases such as bloodstream infections (sepsis), diarrhoea, pneumonia, urinary tract infections and gonorrhoea. The results are cause for high concern, documenting resistance to antibiotics, especially “last resort” antibiotics, in all regions of the world.

Key findings from the report include:

Resistance to the treatment of last resort for life-threatening infections caused by a common intestinal bacteria, Klebsiella pneumoniae–carbapenem antibiotics–has spread to all regions of the world. K. pneumoniae is a major cause of hospital-acquired infections such as pneumonia, bloodstream infections, infections in newborns and intensive-care unit patients. In some countries, because of resistance, carbapenem antibiotics would not work in more than half of people treated for K. pneumoniae infections.

Resistance to one of the most widely used antibacterial medicines for the treatment of urinary tract infections caused by E. coli–fluoroquinolones–is very widespread. In the 1980s, when these drugs were first introduced, resistance was virtually zero. Today, there are countries in many parts of the world where this treatment is now ineffective in more than half of patients.

Treatment failure to the last resort of treatment for gonorrhoea–third generation cephalosporins–has been confirmed in Austria, Australia, Canada, France, Japan, Norway, Slovenia, South Africa, Sweden and the United Kingdom. More than 1 million people are infected with gonorrhoea around the world every day.

Antibiotic resistance causes people to be sick for longer and increases the risk of death. For example, people with MRSA (methicillin-resistant Staphylococcus aureus) are estimated to be 64% more likely to die than people with a non-resistant form of the infection. Resistance also increases the cost of health care with lengthier stays in hospital and more intensive care required.

The suggestions offered for tackling antibiotic resistance will be familiar to many (from the news release),

 People can help tackle resistance by:

  •  using antibiotics only when prescribed by a doctor;
  •  completing the full prescription, even if they feel better;
  •  never sharing antibiotics with others or using leftover prescriptions.

A June 25, 2014 PneumoNP press release describes both the European Union’s response to massive, global antibiotic resistance and the specifics of the new programme (PneumoNP),

In this context, the European Commission launched 15 projects under its7 Framework Programme to fight antimicrobial resistance, with PneumoNP being one of these projects. Started in 2014, the aim of this 4-year project is to develop novel therapeutic and diagnostic tools for bacterial respiratory tract infections, focusing on infections caused by Klebsiella pneumoniae. PneumoNP will pioneer the development of a therapeutic treatment based on a combination of nanocarriers coupled to new antibiotics. This novel combination is expected to enhance the efficiency of antibiotic delivery to the patient. The project is expected to generate:

  • a new inhalable drug system made of a new nanotherapeutic system (an antimicrobial peptide or an active pharmaceutical ingredient and a nanocarrier);
  • a new aerosol technology that will allow direct access to the main focus of infection;
  • an innovative efficiency-efficacy test to follow-up the treatment;
  • a new diagnostic test for faster detection and identification of antibiotic resistance in bacteria causing respiratory infections.

European funding allows PneumoNP to combine scientific research capacities with the expert healthcare capabilities of European enterprises. The result is an interdisciplinary collaboration between 11 teams from 6 EU member states – Spain, Italy, France, Germany, The Netherlands, and Denmark. Each partner has a distinct yet collaborative role according to its own expertise involving a total of 8 work packages.

There is a figure in the news release which illustrates the PneumoNP concept,

Figure 2: PneumoNP concept

Figure 2: PneumoNP concept

There is more information about PneumoNP on its website. I wasn’t able to glean much in the way of technical details (are they using silver nanoparticles, what kind of nanocarriers are they considering, etc.) but I imagine those will emerge with time. There is this from the homepage which features the relatively new (to me) word, theragnostic,

Development of a theragnostic system for the treatment of lung Gram-negative bacterial infections

I assume they are conflating two processes, therapeutics and diagnostics for theragnostics.

European NanoSafety Cluster issues 2014 compendium of projects

A June 16, 2014 news item on Nanowerk profiles a recently published compendium of projects from the European NanoSafety Cluster (Note:  A link has been removed),

The EU NanoSafety Cluster is an initiative to maximise the synergies between the existing FP6 and FP7 projects addressing all aspects of nanosafety including toxicology, ecotoxicology, exposure assessment, mechanisms of interaction, risk assessment and standardisation.

About fifty projects are either completed or running and represent a total RTD investment of €137M, from the NMP and other programmes, under FP6 (13 projects, €31M) and FP7 (34 projects, €106M). [FP 6 and FP 7 are the Sixth Framework Programme and /seventh Framework, respectively; European Union-wide science funding programmes,the Horizon 2020 funding project supersedes FP 7]

These projects together with a significant number of projects supported by government resources in the EU member states and the FP7 associated states, and other projects addressing safety as side objective, represent the valuable efforts of the scientific and industrial research community for progress.

Here’s a description of the compendium from p. 5 of the PDF version of the Compendium of Projects in the European NanoSafety Cluster 2014 Edition,

This is the fourth edition of the Nanosafety Cluster compendium. It documents the status of important EU-funded projects on nanomaterial toxicity and exposure monitoring, integrated risk management, research infrastructure and coordination and support activities as well as regulatory-focussed research on nanosafety.

The compendium is not intended to be a guidance document for human health and environmental safety management of nanotechnologies, as such guidance documents already exist and are widely available.

Neither is the compendium intended to be a medium for the publication of scientific data and research results, as this task is covered by scientific conferences and the peer reviewed press.

The compendium aims to showcase the exciting and important European-wide collaborative research being undertaken to ensure the safe implementation of nanotechnologies, and to act as a one-stop-shop for all stakeholders interested in acquiring an overview of current research activities.This years’ compendium contains information on 30 running (or very recently finished) projects, including new entries describing the projects resulting from the last call of FP7, including eNanoMapper, NanoDefine and FutureNanoNeeds. …

What a good idea! I wonder if there’s an equivalent for the international scene?

Seeing beneath the surface; ancient Roman revealed in wall painting at the Louvre

Here’s a fascinating tale about art and hidden mysteries told at the 245th meeting of the American Chemical Society (ACS) taking place Apr. 7 – 11, 2013, from the Apr. 10, 2013 news release on EurekAlert,

J. Bianca Jackson, Ph.D., who reported on the project, explained that it involved a fresco [located at the Louvre Museum in Paris], which is a mural or painting done on a wall after application of fresh plaster. In a fresco, the artist’s paint seeps into the wet plaster and sets as the plaster dries. The painting becomes part of the wall. The earliest known frescoes date to about 1500 B.C. and were found on the island of Crete in Greece.

“No previous imaging technique, including almost half a dozen commonly used to detect hidden images below paintings, forged signatures of artists and other information not visible on the surface has revealed a lost image in this fresco,” Jackson said. “This opens to door to wider use of the technology in the world of art, and we also used the method to study a Russian religious icon and the walls of a mud hut in one of humanity’s first settlements in what was ancient Turkey.”

Here’s the technology they used to discover the figure hidden in the fresco,

… Termed terahertz spectroscopy, it uses beams of electromagnetic radiation that lie between microwaves, like those used in kitchen ovens, and the infrared rays used in TV remote controls. This radiation is relatively weak, does not damage paintings and does not involve exposure to harmful radiation.

“Terahertz technology has been in use for some time, especially in quality control in the pharmaceutical industry to assure the integrity of pills and capsules, in biomedical imaging and even in homeland security with those whole-body scanners that see beneath clothing at airport security check points,” said Jackson, who is now with the University of Rochester. “But its use in examining artifacts and artworks is relatively new.”

The scientists turned to terahertz technology when suspicions surfaced that a hidden image might lie beneath the brushstrokes of a precious 19th century fresco, Trois hommes armés de lances, in the Louvre’s Campana collection. …

To search for a hidden image, Jackson and colleagues, including Gerard Mourou, Ph.D., of Ècole Polytechnique, and Michel Menu, Ph.D., of the Centre de Recherche et de Restauration des Musées de France, and Vincent Detalle, of the Laboratoire Recherche des Monuments Historiques, probed it with terahertz technology. The process is slow, requiring a few hours to analyze a section the size of a sheet of paper.

“We were amazed, and we were delighted,” said Jackson. “We could not believe our eyes as the image materialized on the screen. Underneath the top painting of the folds of a man’s tunic, we saw an eye, a nose and then a mouth appear. We were seeing what likely was part of an ancient Roman fresco, thousands of years old.”

Who is the man in the fresco? An imperial Roman senator? A patrician? A plebian? A great orator? A ruler who changed the course of history? Or just a wealthy, egotistical landowner who wanted to admire his image on the wall?

Jackson is leaving those questions to art historians.

For anyone interested in Campana,

Giampietro Campana was an Italian art collector in the 1800s whose treasures are now on display in museums around the world. When Campana acquired a work of art, he sometimes restored damaged parts or reworked the original. Art historians believe that Campana painted Trois hommes armés de lances after the fresco was removed from its original wall in Italy and entered his collection.

Campana’s practice of restoring and reworking the original was not unusual for the time,

Artists, including some of the great masters, sometimes re-used canvases, wiping out the initial image or covered old paintings with new works. They often did this in order to avoid the expense of buying a new canvas or to enhance colors and shapes in a prior composition. Frescoes likewise got a refresh, especially when the originals faded, owners tired of the image on the wall or property changed hands.

This project was funded in part by CHARISMA [Cultural Heritage Advanced Research Infrastructure; Synergy for a Multidisciplinary Approach to Conservation/Restoration] as part of the European Union’s Framework Programme 7 (FP 7). This project called to mind the NanoForArt FP7 funded project I mentioned in the context of a Mar. 1, 2013 posting about cave art, frescos, and other examples of rock art and how nanotechnology is enabling conservation and restoration.

In any event, it’s nice to find out that those airport scanners are good for something other than delaying your trip and subjecting you and your knickers to inspection.

Nanotechnology and the labour market in Europe: the NanoEIS project

The Nov. 14, 2012 NanoEIS project announcement on Nanowerk was made by the EthicSchool. The source is a little unexpected (I should note that the announcement also covers the EthicSchool’s inclusion) as this a European Union FP 7- (Framework Programme 7) funded project as per their page on the Cordis website,

Nanotechnology Education for Industry and Society [NanoEIS]
Start date:2012-11-01
End date:2015-10-31
Project Acronym:NANOEIS
Project status:Accepted

Objective: Nanotechnology is an emerging area with strong implications for European society and industry. It is a challenge for the education system to integrate this interdisciplinary and transsectoral subject into curricula shaped mostly along classical disciplines. NanoEIS will evaluate how nanotechnology education has been integrated into secondary schools and universities, how cooperations between different partner institutions were implemented, and in which ways industrial and non-industrial (social) employers have been involved. [emphasis mine] NanoEIS will make, based on a thorough assessment of employer needs, recommendations for curriculum contents as well as for best practice strategies to implement them. This will help to resolve the problem that education contents are not always well matched with the needs of the job market. Improving this situation will benefit both graduates seeking jobs, and industrial / social employers who need specific skills in the professional environment. Nanotechnology education has to start at secondary schools, since nano is by now part of the daily environment and schools need to teach about relevant issues to allow informed consumers to take full advantage of nano-enabled products in a safe and sustainable way. NanoEIS will develop novel teaching and assessment tools for secondary schools. In addition, career choices start in school when decisions about study subjects are made, which should be based on full and relevant information, to achieve a good match between the interests of students and the contents of their studies and courses. A website based on the existing NANOfutures site will be set up, as one-stop shop for information on nanotechnology education for all stakeholders, including secondary school students, university students, educators and education administrators, and both industrial (large industry, SME, start-ups) and social employers (regulatory agencies, media, legal and IP services etc.). [emphasis mine]

I’m happy to see a project dedicated to an analysis of the relationship between education and industry something which is often lacking when ‘experts’ proclaim new skills, training, and education are needed (in this case, regarding nanotechnology) without reference to the labour market. As for the NanoEIS site, it is under construction and will be launched in Dec. 2102. I’m not entirely sure what the reference to NANOfutures means but that site is open.

Here’s more about NanoEIS from the Nov. 13, 2012 posting on the EthicSchool blog,

From this month, Malsch TechnoValuation participates in the EU funded project NanoEIS. Partners from all over Europe will investigate the European labour market for personnel trained in nanotechnology. The relevance of existing nanotechnology education and training in universities, vocational training institutes and secondary schools for the needs of industrial and other employers will also be explored. By 2015, a model curriculum will be made available online.

For anyone interested in EthicSchool and Malsch TechnoValuation, here’s more from the About EthicSchool page (Note: I have removed a link),

ETHICSCHOOL organises workshops and in-company training in Responsible Innovation. As a professional you gain insight in possible societal objections against the technology you are developing. The introduction of new technologies like nanotechnology, life sciences and ICT is accompanied by ethical dilemmas. You make your acquaintance with arguments for and against the development or use of your technology for sensitive applications such as healthcare, security or food. This helps prepare you for the dialogue with concerned citizens and teaches you to target your scarce resources better towards societally desirable products.

ETHICSCHOOL is an initiative taken by Malsch TechnoValuation, a consultancy in the area of Technology and Society, located in Utrecht since 1999.

ETHICSCHOOL builds upon a former European project. This original project was funded by the European Union, contract nr. 036745, 01-09-2007 until 28-02-2009. Partners in this former project were: Malsch TechnoValuation, University of Twente, Radboud University (NL) en TU Darmstadt, Germany.

I have written about Ineke Malsch (the Malsch behind Malsch TechnoValuation and I believe she’s also known as Neelina Herminia Malsch) and her work in an Oct. 11, 2011 posting (scroll down approximately 1/3 of the way). Oddly,

Nano regulatory frameworks are everywhere!

The scene around nanotechnology regulatory frameworks has been frantic (by comparison with any other time period during the 3 years I’ve been blogging about nano) in the last month or so. This is my second attempt this month at pulling together information about nanotechnology regulatory frameworks (my June 9, 2011 posting).

I’ll start off slow and easy with this roundup of sorts with a brief look at the international scene, move on to US initiatives, offer a brief comment on the Canadian situation, and wrap up with Europe.

International

Dr. Andrew Maynard at the University of Michigan Risk Science Center (UMRSC) blog has written a commentary about the ISO’s (*International Organization for Standardization) latest set of nanotechnology guidelines in his May 27, 2011 posting.  From the posting,

ISO/TR 31321:2011: Nanotechnologies – Nanomaterial risk evaluation is unashamedly based on the Environmental Defense Fund/DuPont Nano Risk Framework. Much of the structure and content reflects that of the original – a testament to the thought and effort that went into the first document. …The ISO report is written in a much tighter style than that of the original document, and loses some of the occasionally long-winded expositions on what should be done and why. And the ISO document is more compact – 66 pages as opposed to 104. But from a comparative reading, surprisingly little has been changed from the 2007 document.

It’s build around a framework of six steps:

  1. describe materials and applications
  2. material profiles
  3. evaluate risks
  4. assess risk management options
  5. decide, document, and act
  6. review and adapt

From the posting,

Inherent to this framework is the need to make situation-specific decisions that are guided by the Technical Report but not necessarily prescribed by it, and the need to constantly review and revise procedures and decisions. This built-in flexibility and adaptability makes ISO/TR 31321 a powerful tool for developing tailored nanomaterial management strategies that are responsive to new information as it becomes available. It also presents an integrative approach to using materials safely, that deals with the need to make decisions under considerable uncertainty by blurring the line between risk assessment and risk management.

Andrew’s view of these guidelines is largely positive and you can get more details and history by viewing his original commentary. (I first mentioned these new ISO guidelines in my May 18, 2011 posting.)

Sticking with the international scene (in this case, ISO), there was a June 13, 2011 news item on Nanowerk about a new ISO general liability classification for nanotechnology and alternative energy (from the news item),

The new classifications to address the growing use of nanotechnology are Nanomaterial Distributors and Nanomaterial Manufacturing. The once-limited use of nanotechnology in electronics and information technology industries is now swiftly permeating the consumer marketplace, from cosmetics to clothing and more. The Nanomaterial Distributors classification applies to risks that sell nanomaterials to others, and the Nanomaterial Manufacturing classification applies to risks that manufacture or engineer nanomaterials for others.

“With heightened interest to reduce the carbon footprint, establish energy independence, and increase the use of renewable resources, alternative power is a priority for many,” said Beth Fitzgerald, vice president of commercial lines and modeling at ISO. “In response to the growing demand for alternative energy, ISO introduced classifications for risks in three main areas: biofuels, solar energy, and wind energy. The new classifications will allow for future evaluation of the loss experience of those emerging markets.”

The biofuels classifications consist of Biofuels Manufacturing and Biofuels Distributors. Since ethanol already has a widespread and accepted use, a further distinction is made between “ethanol” and “biofuels other than ethanol.”

The solar energy classifications include Solar Energy Farms, Solar Energy Equipment Dealers or Distributors, and Solar Energy Equipment Manufacturing. The wind energy classifications include Wind Turbine Contractors – Installation, Service, or Repair and onshore and offshore Wind Farms.

* I have for many years understood that ISO is the International Standards Organization and I see from a note on the UMRSC blog that these days it is the International Organization for Standardization.

US

On the US front, three different agencies have made announcements that in one way or another will have an impact on the nanotechnology regulatory frameworks in that country.

The White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) recently released a set of principles for the regulation and oversight of nanotechnology applications and guidance for the development and implementation of policies at the agency level. From the June 9, 2011 news item on Nanowerk,

The realization of nanotechnology’s full potential will require continued research and flexible, science-based approaches to regulation that protect public health and the environment while promoting economic growth, innovation, competitiveness, exports, and job creation.

In furtherance of those goals, the White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) has developed a set of principles (pdf) specific to the regulation and oversight of applications of nanotechnology, to guide the development and implementation of policies at the agency level.

These principles reinforce a set of overarching principles (pdf) for the regulation and oversight of emerging technologies released on March 11, 2011. They also reflect recommendations from a report on nanotechnology (pdf) by the President’s Council of Advisors on Science and Technology. The report encourages Federal support for the commercialization of nanotech products and calls for the development of rational, science- and risk-based regulatory approaches that would be based on the full array of a material’s properties and their plausible risks and not simply on the basis of size alone.

You can read more about the guidelines at Nanowerk or on the Environemental Expert website here.

Back over on the UMRSC blog, Dr. Andrew Maynard had these comments in his June 13, 2011 posting,

In a joint memorandum, the Office of Science and Technology Policy, the Office of Management and Budget and the Office of the United States Trade Representative laid out Policy Principles for the U.S. Decision Making Concerning Regulations and Oversight of Applications of Nanotechnology and Nanomaterials.

Reading through it, a number of themes emerge, including:

  • Existing regulatory frameworks provide a firm foundation for the oversight of nanomaterials, but there is a need to respond to new scientific evidence on potential risks, and to consider administrative and legal modifications to the regulatory landscape should the need arise.
  • Regulatory action on nanomaterials should be based on scientific evidence of risk, and not on definitions of materials that do not necessarily reflect the evidence-based likelihood of a material causing harm.
  • There should be no prior judgement on whether nanomaterials are intrinsically benign or harmful, in the absence of supporting scientific evidence.
  • Transparency and communication are important to ensuring effective evidence-based regulation.

Overall, this is a strong set of policy principles that lays the groundwork for developing regulation that is grounded in science and not swayed by speculative whims, and yet is responsive and adaptive to emerging challenges. Gratifyingly, the memorandum begins to touch on some of the concerns I have expressed previously about approaches to nanomaterial regulation that seem not to be evidence-based. There is a reasonable chance that they will help move away from the dogma that engineered nanomaterials should be regulated separately because they are new, to a more nuanced and evidence-based approach to ensuring the safe use of increasingly sophisticated materials. Where it perhaps lacks is in recognizing the importance of other factors in addition to science in crafting effective regulation, and in handling uncertainty in decision making.

June 9, 2011 was quite the day as in addition to the White House documents, the US Environmental Protection Agency (EPA) and the US Food and Drug Administration (FDA) both announced public consultations on nanotechnology regulation.

From the June 9, 2011 news item on Nanowerk about the US EPA public consultation,

The U.S. Environmental Protection Agency announced today it plans to obtain information on nanoscale materials in pesticide products. Under the requirements of the law, EPA will gather information on what nanoscale materials are present in pesticide products to determine whether the registration of a pesticide may cause unreasonable adverse effects on the environment and human health. The proposed policy will be open for public comment.

“We want to obtain timely and accurate information on what nanoscale materials may be in pesticide products, “said Steve Owens assistant administrator for EPA’s Office of Chemical Safety and Pollution Prevention. “This information is needed for EPA to meet its requirement under the law to protect public health and the environment.”

Comments on the Federal Register notice will be accepted until 30 days after publication. The notice will be available at www.regulations.gov in docket number EPA–HQ–OPP–2010-0197. More information or to read the proposed notice: http://www.epa.gov/pesticides/regulating/nanotechnology.html [Pesticides; Policies Concerning Products Containing Nanoscale Materials; Opportunity for Public Comment]

The US FDA has taken a more complicated approach to its public consultation with two notices being issued about the same consultation. The June 9, 2011 news item on Nanowerk had this to say,

The U.S. Food and Drug Administration today released draft guidance to provide regulated industries with greater certainty about the use of nanotechnology, which generally involves materials made up of particles that are at least one billionth of a meter in size. The guidance outlines the agency’s view on whether regulated products contain nanomaterials or involve the application of nanotechnology.

The draft guidance, “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology”, is available online and open for public comment. It represents the first step toward providing regulatory clarity on the FDA’s approach to nanotechnology.

Specifically, the agency named certain characteristics – such as the size of nanomaterials used and the exhibited properties of those materials – that may be considered when attempting to identify applications of nanotechnology in regulated products.

“With this guidance, we are not announcing a regulatory definition of nanotechnology,” said Margaret A. Hamburg, MD, Commissioner of Food and Drugs. “However, as a first step, we want to narrow the discussion to these points and work with industry to determine if this focus is an appropriate starting place.”

Then there was a June 15, 2011 news item on Nanowerk offering more details about the draft guidance announcement of June 9, 2011,

The guidelines list things that might be considered when deciding if nanotechnology was used on a product regulated by FDA—including the size of the nanomaterials that were used, and what their properties are.

And FDA wants industry leaders and the public to weigh-in.

Nanotechnology—the science of manipulating materials on a scale so small that it can’t be seen with a regular microscope—could have a broad range of applications, such as increasing the effectiveness of a particular drug or improving the packaging of food or cosmetics. “Nanotechnology is an emerging technology that has the potential to be used in a broad array of FDA-regulated medical products, foods, and cosmetics,” says Carlos Peña, director of FDA’s emerging technology programs. “But because materials in the nanoscale dimension may have different chemical, physical, or biological properties from their larger counterparts, FDA is monitoring the technology to assure such use is beneficial.”

In other words, using nanotechnology can change the way a product looks or operates, Peña says.

Although the technology is still evolving, it’s already in use as display technology for laptop computers, cell phones, and digital cameras. In the medical community, a number of manufacturers have used nanotechnology in:

  • Drugs
  • Medical imaging
  • Antimicrobial materials
  • Medical devices
  • Sunscreens

Andrew Maynard in his previously noted June 13, 2011 posting on on the UMRSC blog had this to say  about the EPA’s draft document,

This is a long and somewhat convoluted document, that spends some time outlining what the agency considers is an engineered nanomaterial, and reviewing nanomaterial hazard data.

Reading the document, EPA still seems somewhat tangled up with definitions of engineered nanomaterials. After outlining conventional attributes associated with engineered nanomaterials, including structures between ~1 – 100 nm and unique or novel properties, the document states,

“These elements do not readily work in a regulatory context because of the high degree of subjectivity involved with interpreting such phrases as “unique or novel properties” or “manufactured or engineered to take advantage of these properties” Moreover the contribution of these subjective elements to risk has not been established.”

This aligns with where my own thinking has been moving in recent years. Yet following this statement, the document reverts back to considering nanoparticles between 1 – 100 nm as the archetypal nanomaterial, and intimates “novel” properties such as “larger surface area per unit volume and/or quantum effects” as raising new risk concerns.

Canadian segue

I’ll point out here that Health Canada’s Interim Policy definition also adheres to the 1 to 100 nm definition for a nanomaterial, a concern I expressed in my submission to the public consultation held last year. Interestingly, since 29 submissions does seem particularly daunting to read there has yet to be any public response to these submissions. Not even a list of which agencies and individuals made submissions.

Back to US

Andrew also comments on the FDA document,

The FDA Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology is a very different kettle of fish to the EPA document. It is overtly responsive to the White House memo; it demonstrates a deep understanding of the issues surrounding nanotechnology and regulation; and it is mercifully concise.

To be fair, the scope of the draft guidance is limited to helping manufacturers understand how the agency is approaching nanotechnology-enabled products under their purview. But this is something it does well.

One of the more significant aspects of the guidance is the discussion on regulatory definitions of nanomaterials. Following a line of reasoning established some years ago, the agency focuses on material properties rather than rigid definitions:

“FDA has not to date established regulatory definitions of “nanotechnology,” “nanoscale” or related terms… Based on FDA’s current scientific and technical understanding of nanomaterials and their characteristics, FDA believes that evaluations of safety, effectiveness or public health impact of such products should consider the unique properties and behaviors that nanomaterials may exhibit”

I recommend reading the full text of Andrew’s comments.

Europe

Meanwhile, there was a June 10, 2011 news item on Nanowerk about the availability of  28 presentations from a May 10-12, 2011 joint European workshop hosted by the Engineered NanoParticle Risk Assessment (ENPRA) FP (Framework Programme) 7 project and the European Commission’s Joint Research Centre. From the news item about the Challenges of Regulation and Risk Assessment of Nanomaterials workshop,

Twenty-eight presentations delivered at the Joint JRC Nano event and 2nd ENPRA Stakeholders Workshop are now available on-line: ENPRA Workshop 2011 – Programme with Presentations.

The workshop (by invitation only) involved about 90 participants, from industry, government, NGOs, and academia. …

During two days and a half, 34 experts from 26 different organisations informed the participants on the latest scientific progress in the field of nanoparticles risk assessment produced within national and European projects, and first results of ENPRA FP7 project were presented in detail. In addition, recent developments concerning legislation in the EU and beyond were discussed.

Amongst other participants, you can include representatives of EU Associate and Candidate Countries, environment and workers’ protection organisations, CAIQ (Chinese Academy of Inspection and Quarantine), US-EPA, ECHA, and EFSA.

To close this piece (and I want to do that very badly), I’m going to give Tim Harper at his TNT blog (on the Cientifica website) the final word from his June 10, 2011 posting,

The White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) has developed a set of principles (pdf) specific to the regulation and oversight of applications of nanotechnology, to guide the development and implementation of policies at the agency level.

I’m glad to see that it addresses those two old bugbears, the confusion between risk and hazard and the prejudging of issues without reference to scientific evidence …

It is an approach which appears to diverge slightly from the European adoption of the precautionary principle …

As with any regulation, the problems will arise not from the the original wording, but through its (mis)interpretation and inconsistent application.