Category Archives: risk

Not enough talk about nano risks?

It’s not often that a controversy amongst visual artists intersects with a story about carbon nanotubes, risk, and the roles that  scientists play in public discourse.

Nano risks

Dr. Andrew Maynard, Director of the Risk Innovation Lab at Arizona State University, opens the discussion in a March 29, 2016 article for the appropriately named website, The Conversation (Note: Links have been removed),

Back in 2008, carbon nanotubes – exceptionally fine tubes made up of carbon atoms – were making headlines. A new study from the U.K. had just shown that, under some conditions, these long, slender fiber-like tubes could cause harm in mice in the same way that some asbestos fibers do.

As a collaborator in that study, I was at the time heavily involved in exploring the risks and benefits of novel nanoscale materials. Back then, there was intense interest in understanding how materials like this could be dangerous, and how they might be made safer.

Fast forward to a few weeks ago, when carbon nanotubes were in the news again, but for a very different reason. This time, there was outrage not over potential risks, but because the artist Anish Kapoor had been given exclusive rights to a carbon nanotube-based pigment – claimed to be one of the blackest pigments ever made.

The worries that even nanotech proponents had in the early 2000s about possible health and environmental risks – and their impact on investor and consumer confidence – seem to have evaporated.

I had covered the carbon nanotube-based coating in a March 14, 2016 posting here,

Surrey NanoSystems (UK) is billing their Vantablack as the world’s blackest coating and they now have a new product in that line according to a March 10, 2016 company press release (received via email),

A whole range of products can now take advantage of Vantablack’s astonishing characteristics, thanks to the development of a new spray version of the world’s blackest coating material. The new substance, Vantablack S-VIS, is easily applied at large scale to virtually any surface, whilst still delivering the proven performance of Vantablack.

Oddly, the company news release notes Vantablack S-VIS could be used in consumer products while including the recommendation that it not be used in products where physical contact or abrasion is possible,

… Its ability to deceive the eye also opens up a range of design possibilities to enhance styling and appearance in luxury goods and jewellery [emphasis mine].

… “We are continuing to develop the technology, and the new sprayable version really does open up the possibility of applying super-black coatings in many more types of airborne or terrestrial applications. Possibilities include commercial products such as cameras, [emphasis mine] equipment requiring improved performance in a smaller form factor, as well as differentiating the look of products by means of the coating’s unique aesthetic appearance. It’s a major step forward compared with today’s commercial absorber coatings.”

The structured surface of Vantablack S-VIS means that it is not recommended for applications where it is subject to physical contact or abrasion. [emphasis mine] Ideally, it should be applied to surfaces that are protected, either within a packaged product, or behind a glass or other protective layer.

Presumably Surrey NanoSystems is looking at ways to make its Vantablack S-VIS capable of being used in products such as jewellery, cameras, and other consumers products where physical contact and abrasions are a strong possibility.

Andrew has pointed questions about using Vantablack S-VIS in new applications (from his March 29, 2016 article; Note: Links have been removed),

The original Vantablack was a specialty carbon nanotube coating designed for use in space, to reduce the amount of stray light entering space-based optical instruments. It was this far remove from any people that made Vantablack seem pretty safe. Whatever its toxicity, the chances of it getting into someone’s body were vanishingly small. It wasn’t nontoxic, but the risk of exposure was minuscule.

In contrast, Vantablack S-VIS is designed to be used where people might touch it, inhale it, or even (unintentionally) ingest it.

To be clear, Vantablack S-VIS is not comparable to asbestos – the carbon nanotubes it relies on are too short, and too tightly bound together to behave like needle-like asbestos fibers. Yet its combination of novelty, low density and high surface area, together with the possibility of human exposure, still raise serious risk questions.

For instance, as an expert in nanomaterial safety, I would want to know how readily the spray – or bits of material dislodged from surfaces – can be inhaled or otherwise get into the body; what these particles look like; what is known about how their size, shape, surface area, porosity and chemistry affect their ability to damage cells; whether they can act as “Trojan horses” and carry more toxic materials into the body; and what is known about what happens when they get out into the environment.

Risk and the roles that scientists play

Andrew makes his point and holds various groups to account (from his March 29, 2016 article; Note: Links have been removed),

… in the case of Vantablack S-VIS, there’s been a conspicuous absence of such nanotechnology safety experts in media coverage.

This lack of engagement isn’t too surprising – publicly commenting on emerging topics is something we rarely train, or even encourage, our scientists to do.

And yet, where technologies are being commercialized at the same time their safety is being researched, there’s a need for clear lines of communication between scientists, users, journalists and other influencers. Otherwise, how else are people to know what questions they should be asking, and where the answers might lie?

In 2008, initiatives existed such as those at the Center for Biological and Environmental Nanotechnology (CBEN) at Rice University and the Project on Emerging Nanotechnologies (PEN) at the Woodrow Wilson International Center for Scholars (where I served as science advisor) that took this role seriously. These and similar programs worked closely with journalists and others to ensure an informed public dialogue around the safe, responsible and beneficial uses of nanotechnology.

In 2016, there are no comparable programs, to my knowledge – both CBEN and PEN came to the end of their funding some years ago.

Some of the onus here lies with scientists themselves to make appropriate connections with developers, consumers and others. But to do this, they need the support of the institutions they work in, as well as the organizations who fund them. This is not a new idea – there is of course a long and ongoing debate about how to ensure academic research can benefit ordinary people.

Media and risk

As mainstream media such as newspapers and broadcast news continue to suffer losses in audience numbers, the situation vis à vis science journalism has changed considerably since 2008. Finding information is more of a challenge even for the interested.

As for those who might be interested, the chances of catching their attention are considerably more challenging. For example, some years ago scientists claimed to have achieved ‘cold fusion’ and there were television interviews (on the 60 minutes tv programme, amongst others) and cover stories in Time magazine and Newsweek magazine, which you could find in the grocery checkout line. You didn’t have to look for it. In fact, it was difficult to avoid the story. Sadly, the scientists had oversold and misrepresented their findings and that too was extensively covered in mainstream media. The news cycle went on for months. Something similar happened in 2010 with ‘arsenic life’. There was much excitement and then it became clear that scientists had overstated and misrepresented their findings. That news cycle was completed within three or fewer weeks and most members of the public were unaware. Media saturation is no longer what it used to be.

Innovative outreach needs to be part of the discussion and perhaps the Vantablack S-VIS controversy amongst artists can be viewed through that lens.

Anish Kapoor and his exclusive rights to Vantablack

According to a Feb. 29, 2016 article by Henri Neuendorf for artnet news, there is some consternation regarding internationally known artist, Anish Kapoor and a deal he has made with Surrey Nanosystems, the makers of Vantablack in all its iterations (Note: Links have been removed),

Anish Kapoor provoked the fury of fellow artists by acquiring the exclusive rights to the blackest black in the world.

The Indian-born British artist has been working and experimenting with the “super black” paint since 2014 and has recently acquired exclusive rights to the pigment according to reports by the Daily Mail.

The artist clearly knows the value of this innovation for his work. “I’ve been working in this area for the last 30 years or so with all kinds of materials but conventional materials, and here’s one that does something completely different,” he said, adding “I’ve always been drawn to rather exotic materials.”

This description from his Wikipedia entry gives some idea of Kapoor’s stature (Note: Links have been removed),

Sir Anish Kapoor, CBE RA (Hindi: अनीश कपूर, Punjabi: ਅਨੀਸ਼ ਕਪੂਰ), (born 12 March 1954) is a British-Indian sculptor. Born in Bombay,[1][2] Kapoor has lived and worked in London since the early 1970s when he moved to study art, first at the Hornsey College of Art and later at the Chelsea School of Art and Design.

He represented Britain in the XLIV Venice Biennale in 1990, when he was awarded the Premio Duemila Prize. In 1991 he received the Turner Prize and in 2002 received the Unilever Commission for the Turbine Hall at Tate Modern. Notable public sculptures include Cloud Gate (colloquially known as “the Bean”) in Chicago’s Millennium Park; Sky Mirror, exhibited at the Rockefeller Center in New York City in 2006 and Kensington Gardens in London in 2010;[3] Temenos, at Middlehaven, Middlesbrough; Leviathan,[4] at the Grand Palais in Paris in 2011; and ArcelorMittal Orbit, commissioned as a permanent artwork for London’s Olympic Park and completed in 2012.[5]

Kapoor received a Knighthood in the 2013 Birthday Honours for services to visual arts. He was awarded an honorary doctorate degree from the University of Oxford in 2014.[6] [7] In 2012 he was awarded Padma Bhushan by Congress led Indian government which is India’s 3rd highest civilian award.[8]

Artists can be cutthroat but they can also be prankish. Take a look at this image of Kapoor and note the blue background,

Artist Anish Kapoor is known for the rich pigments he uses in his work. (Image: Andrew Winning/Reuters)

Artist Anish Kapoor is known for the rich pigments he uses in his work. (Image: Andrew Winning/Reuters)

I don’t know why or when this image (used to illustrate Andrew’s essay) was taken so it may be coincidental but the background for the image brings to mind, Yves Klein and his International Klein Blue (IKB) pigment. From the IKB Wikipedia entry,

L'accord bleu (RE 10), 1960, mixed media piece by Yves Klein featuring IKB pigment on canvas and sponges Jaredzimmerman (WMF) - Foundation Stedelijk Museum Amsterdam Collection

L’accord bleu (RE 10), 1960, mixed media piece by Yves Klein featuring IKB pigment on canvas and sponges Jaredzimmerman (WMF) – Foundation Stedelijk Museum Amsterdam Collection

Here’s more from the IKB Wikipedia entry (Note: Links have been removed),

International Klein Blue (IKB) was developed by Yves Klein in collaboration with Edouard Adam, a Parisian art paint supplier whose shop is still in business on the Boulevard Edgar-Quinet in Montparnasse.[1] The uniqueness of IKB does not derive from the ultramarine pigment, but rather from the matte, synthetic resin binder in which the color is suspended, and which allows the pigment to maintain as much of its original qualities and intensity of color as possible.[citation needed] The synthetic resin used in the binder is a polyvinyl acetate developed and marketed at the time under the name Rhodopas M or M60A by the French pharmaceutical company Rhône-Poulenc.[2] Adam still sells the binder under the name “Médium Adam 25.”[1]

In May 1960, Klein deposited a Soleau envelope, registering the paint formula under the name International Klein Blue (IKB) at the Institut national de la propriété industrielle (INPI),[3] but he never patented IKB. Only valid under French law, a soleau enveloppe registers the date of invention, according to the depositor, prior to any legal patent application. The copy held by the INPI was destroyed in 1965. Klein’s own copy, which the INPI returned to him duly stamped is still extant.[4]

In short, it’s not the first time an artist has ‘owned’ a colour. Kapoor is not a performance artist as was Klein but his sculptural work lends itself to spectacle and to stimulating public discourse. As to whether or not, this is a prank, I cannot say but it has stimulated a discourse which ranges from intellectual property and artists to the risks of carbon nanotubes and the role scientists could play in the discourse about the risks associated with emerging technologies.

Regardless of how is was intended, bravo to Kapoor.

More reading

Andrew’s March 29, 2016 article has also been reproduced on Nanowerk and Slate.

Johathan Jones has written about Kapoor and the Vantablack  controversy in a Feb. 29, 2016 article for The Guardian titled: Can an artist ever really own a colour?

Inhaling buckyballs (C60 fullerenes)

Carbon nanotubes (also known as buckytubes) have attracted most of the attention where carbon nanomaterials and health and safety are concerned. But, University of Michigan researchers opted for a change of pace and focused their health and safety research on buckyballs (also known as C60 or fullerenes) according to a Feb. 24, 2016 news item on Nanowerk,

Scientists at the University of Michigan have found evidence that some carbon nanomaterials can enter into immune cell membranes, seemingly going undetected by the cell’s built-in mechanisms for engulfing and disposing of foreign material, and then escape through some unidentified pathway. [emphasis mine]

The researchers from the School of Public Health and College of Engineering say their findings of a more passive entry of the materials into cells is the first research to show that the normal process of endocytosis-phagocytosis isn’t always activated when cells are confronted with tiny Carbon 60 (C60 ) molecules.

A Feb. 23, 2016 University of Michigan news release (also on EurekAlert but dated Feb. 24, 2016), which originated the news item, provides more detail about the research,

… This study examined nanomaterials known as carbon fullerenes, in this case C60, which has a distinct spherical shape.

Over the last decade, scientists have found these carbon-based materials useful in a number of commercial products, including drugs, medical devices, cosmetics, lubricants, antimicrobial agents and more. Fullerenes also are produced in nature through events like volcanic eruptions and wildfires.

The concern is that however exposed, commercially or naturally, little is known about how inhaling these materials impacts health.

“It’s entirely possible that even tiny amounts of some nanomaterials could cause altered cellular signaling,” said Martin Philbert, dean and professor of toxicology at the U-M School of Public Health.

Philbert said much of the previously published research bombarded cells with large amounts of particle clusters, unlike a normal environmental exposure.

The U-M researchers examined various mechanisms of cell entry through a combination of classical biological, biophysical and newer computational techniques, using models developed by a team led by Angela Violi to determine how C60 molecules find their way into living immune cells of mice.

They found that the C60 particles in low concentrations were entering the membrane individually, without perturbing the structure of the cell enough to trigger its normal response.

“Computational modeling of C60 interacting with lipid bilayers, representative of the cellular membrane, show that particles readily diffuse into biological membranes and find a thermodynamically stable equilibrium in an eccentric position within the bilayer,” said Violi, U-M professor of mechanical engineering, chemical engineering, biomedical engineering, and macromolecular science and engineering.

“The surprising contribution of passive modes of cellular entry provides new avenues for toxicological research, as we still don’t know exactly what are the mechanisms that cause this crossing.”

So, while the buckyballs enter cells, they also escape from them somehow. I wonder if the mechanisms that allow them to enter the cells are similar to the ones that allow them to escape. Regardless, here’s a link to and a citation for the paper,

C60 fullerene localization and membrane interactions in RAW 264.7 immortalized mouse macrophages by K. A. Russ, P. Elvati, T. L. Parsonage, A. Dews, J. A. Jarvis, M. Ray, B. Schneider, P. J. S. Smith, P. T. F. Williamson, A. Violi and M. A. Philbert. Nanoscale, 2016, 8, 4134-4144 DOI: 10.1039/C5NR07003A First published online 25 Jan 2016

This paper is behind a paywall.

Hypersensitivity to nanomedicine: the CARPA reaction

There is some intriguing research (although I do have a reservation) into some unexpected side effects that nanomedicine may have according to a Feb. 23, 2016 news item on phys.org,

Keywords such as nano-, personalized-, or targeted medicine sound like bright future. What most people do not know, is that nanomedicines can cause severe undesired effects for actually being too big! Those modern medicines easily achieve the size of viruses which the body potentially recognizes as foreign starting to defend itself against —a sometimes severe immune response unfolds.

The CARPA-phenomenon (Complement Activation-Related PseudoAllergy) is a frequent hypersensitivity response to nanomedicine application. Up to 100 patients worldwide suffer from severe reactions, such as cardiac distress, difficulty of breathing, chest and back pain or fainting each day when their blood gets exposed to certain nanoparticles during medical treatment. Every 10 days one patient even dies due to an uncontrollable anaphylactoid reaction.

Apart from being activated in a different way, this pseudoallergy has the same symptoms as a common allergy, bearing a crucial difference:  the reaction is taking place without previous sensitizing exposure to a substance, making it hard to predict, whether a person will react to a specific nanodrug or be safe. Intrigued by this vital challenge, János Szebeni from Semmelweis University, Budapest, has been working with scientific verve on the decipherment and prevention of the CARPA phenomenon for more than 20 years. With his invaluable support De Gruyter´s European Journal of Nanomedicine (EJNM) lately dedicated an elaborate compilation of the most recent scientific advances on CARPA, presented by renowned experts on the subject.

A Feb. 23, 2016 De Gruyter Publishers press release, which originated the news item, provides more detail,

Interestingly it´s pigs that turned out to serve as best model for research on the complex pathomechanism, diagnosis and potential treatment of CARPA. “Pigs´ sensitivity equals that of humans responding most vehemently to reactogenic nanomedicines”, Szebeni states.  In a contribution to EJNM´s compilation on CARPA, Rudolf Urbanics and colleagues show that reactions to specific nanodrugs are even quantitatively reproducible in pigs … . Szebeni: “This is absolutely rare in allergy-research. In these animals the endpoint of the overreaction is reflected in a rise of pulmonary arterial pressure, being as accurate as a Swiss watch”. Pigs can thus be used for drug screening and prediction of the CARPAgenic potential of nanomedicines. This becomes increasingly important with the ever growing interest in modern drugs requiring reliable preclinical safety assays during the translation process from bench to bedside. Results might also help to personalize nanomedicine administration schedules during for example the targeted treatment of cancer. The same holds true for a very recently developed in vitro immunoassay. By simply using a patient´s blood sample, it tests for potential CARPA reactions even before application of specific nanodrugs.

Here’s a link to and a citation for the paper,

Lessons learned from the porcine CARPA model: constant and variable responses to different nanomedicines and administration protocols by Rudolf Urbanics, Péter Bedőcs, János Szebeni. European Journal of Nanomedicine. Volume 7, Issue 3, Pages 219–231, ISSN (Online) 1662-596X, ISSN (Print) 1662-5986, DOI: 10.1515/ejnm-2015-0011, June 2015

This paper appears to be open access.

As for reservations, I’m not sure what occasioned the news release so many months post publication of the paperand it should be noted that János Szebeni seems to be the paper’s lead author and the editor of the European Journal of Nanomedicine.

Short term exposure to engineered nanoparticles used for semiconductors not too risky?

Short term exposure means anywhere from 30 minutes to 48 hours according to the news release and the concentration is much higher than would be expected in current real life conditions. Still, this research from the University of Arizona and collaborators represents an addition to the data about engineered nanoparticles (ENP) and their possible impact on health and safety. From a Feb. 22, 2016 news item on phys.org,

Short-term exposure to engineered nanoparticles used in semiconductor manufacturing poses little risk to people or the environment, according to a widely read research paper from a University of Arizona-led research team.

Co-authored by 27 researchers from eight U.S. universities, the article, “Physical, chemical and in vitro toxicological characterization of nanoparticles in chemical mechanical planarization suspensions used in the semiconductor industry: towards environmental health and safety assessments,” was published in the Royal Society of Chemistry journal Environmental Science Nano in May 2015. The paper, which calls for further analysis of potential toxicity for longer exposure periods, was one of the journal’s 10 most downloaded papers in 2015.

A Feb. 17, 2016 University of Arizona news release (also on EurekAlert), which originated the news item, provides more detail,

“This study is extremely relevant both for industry and for the public,” said Reyes Sierra, lead researcher of the study and professor of chemical and environmental engineering at the University of Arizona.

Small Wonder

Engineered nanoparticles are used to make semiconductors, solar panels, satellites, food packaging, food additives, batteries, baseball bats, cosmetics, sunscreen and countless other products. They also hold great promise for biomedical applications, such as cancer drug delivery systems.

Designing and studying nano-scale materials is no small feat. Most university researchers produce them in the laboratory to approximate those used in industry. But for this study, Cabot Microelectronics provided slurries of engineered nanoparticles to the researchers.

“Minus a few proprietary ingredients, our slurries were exactly the same as those used by companies like Intel and IBM,” Sierra said. Both companies collaborated on the study.

The engineers analyzed the physical, chemical and biological attributes of four metal oxide nanomaterials — ceria, alumina, and two forms of silica — commonly used in chemical mechanical planarization slurries for making semiconductors.

Clean Manufacturing

Chemical mechanical planarization is the process used to etch and polish silicon wafers to be smooth and flat so the hundreds of silicon chips attached to their surfaces will produce properly functioning circuits. Even the most infinitesimal scratch on a wafer can wreak havoc on the circuitry.

When their work is done, engineered nanoparticles are released to wastewater treatment facilities. Engineered nanoparticles are not regulated, and their prevalence in the environment is poorly understood [emphasis mine].

Researchers at the UA and around the world are studying the potential effects of these tiny and complex materials on human health and the environment.

“One of the few things we know for sure about engineered nanoparticles is that they behave very differently than other materials,” Sierra said. “For example, they have much greater surface area relative to their volume, which can make them more reactive. We don’t know whether this greater reactivity translates to enhanced toxicity.”

The researchers exposed the four nanoparticles, suspended in separate slurries, to adenocarcinoma human alveolar basal epithelial cells at doses up to 2,000 milligrams per liter for 24 to 38 hours, and to marine bacteria cells, Aliivibrio fischeri, up to 1,300 milligrams per liter for approximately 30 minutes.

These concentrations are much higher than would be expected in the environment, Sierra said.

Using a variety of techniques, including toxicity bioassays, electron microscopy, mass spectrometry and laser scattering, to measure such factors as particle size, surface area and particle composition, the researchers determined that all four nanoparticles posed low risk to the human and bacterial cells.

“These nanoparticles showed no adverse effects on the human cells or the bacteria, even at very high concentrations,” Sierra said. “The cells showed the very same behavior as cells that were not exposed to nanoparticles.”

The authors recommended further studies to characterize potential adverse effects at longer exposures and higher concentrations.

“Think of a fish in a stream where wastewater containing nanoparticles is discharged,” Sierra said. “Exposure to the nanoparticles could be for much longer.”

Here’s a link to and a citation for the paper,

Physical, chemical, and in vitro toxicological characterization of nanoparticles in chemical mechanical planarization suspensions used in the semiconductor industry: towards environmental health and safety assessments by David Speed, Paul Westerhoff, Reyes Sierra-Alvarez, Rockford Draper, Paul Pantano, Shyam Aravamudhan, Kai Loon Chen, Kiril Hristovski, Pierre Herckes, Xiangyu Bi, Yu Yang, Chao Zeng, Lila Otero-Gonzalez, Carole Mikoryak, Blake A. Wilson, Karshak Kosaraju, Mubin Tarannum, Steven Crawford, Peng Yi, Xitong Liu, S. V. Babu, Mansour Moinpour, James Ranville, Manuel Montano, Charlie Corredor, Jonathan Posner, and Farhang Shadman. Environ. Sci.: Nano, 2015,2, 227-244 DOI: 10.1039/C5EN00046G First published online 14 May 2015

This is open access but you may need to register before reading the paper.

The bit about nanoparticles’ “… prevalence in the environment is poorly understood …”and the focus of this research reminded me of an April 2014 announcement (my April 8, 2014 posting; scroll down about 40% of the way) regarding a new research network being hosted by Arizona State University, the LCnano network, which is part of the Life Cycle of Nanomaterials project being funded by the US National Science Foundation. The network’s (LCnano) director is Paul Westerhoff who is also one of this report’s authors.

US National Institute of Occupational Heath and Safety (NIOSH) issues a draft bulletin about silver nanoparticles

The US National Institute of Occupational Health and Safety (NIOSH) is requesting comments on a draft version of the NIOSH Current Intelligence Bulletin: Health Effects of Occupational Exposure to Silver Nanoparticles (PDF of 321 pp.) according to a Jan. 21, 2016 notice on the US Federal Register,

On December 19, 2012, the National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention announced in the Federal Registerhttp://www.gpo.gov/fdsys/pkg/FR-2012-12-19/pdf/2012-30515.pdf plans to evaluate the scientific data on silver nanomaterials and to issue its findings on the potential health risks. A draft document entitled, Health Effects of Occupational Exposure to Silver Nanomaterials, has been developed which contains a review and assessment of the currently available scientific literature on the toxicological effects of exposure to silver nanoparticles in experimental animal and cellular systems, and on the occupational exposures to silver dust and fume and the associated health effects. An emphasis area of this review is evaluating the scientific evidence on the role of particle size on the toxicological effects of silver, including the evidence basis to evaluate the adequacy of the current NIOSH recommended exposure limit (REL) for silver (metal dust and soluble compounds, as Ag) [available at: http://www.cdc.gov/niosh/npg/npgd0557.html].

Recommendations are provided for the safe handling of silver nanoparticles, and research needs are proposed to fill important data gaps in the current scientific literature on the potential adverse health effects of occupational exposure to silver nanoparticles. NIOSH is seeking comments on the draft document and plans to have a public meeting to discuss the document. To view the notice and related materials, visit www.regulations.gov and enter CDC-2016-0001 in the field and click “Search.” This draft document does not have the force or effect of the law.

As of a Feb. 10, 2016 NIOSH notice on the US Federal Register (H/T Lynn Bergeson in a Feb. 11, 2016 post on Nanotechnology Now), the public comment period has been extended,

DATES:
NIOSH is extending the comment period on the document published January 21, 2016 (81 FR 3425). Electronic or written comments must be received by April 22, 2016.

ADDRESSES:
You may submit comments, identified by CDC-2016-0001 and docket number NIOSH-260-A, by any of the following methods:

Federal eRulemaking Portal: www.regulations.gov Follow the instructions for submitting comments.
Mail: National Institute for Occupational Safety and Health, NIOSH Docket Office, 1090 Tusculum Avenue, MS C-34, Cincinnati, Ohio 45226-1998.

There will a public meeting about this draft bulletin to be held in Ohio (from the US Federal Register Jan. 21, 2016 notice , Note: Given the recent extension for comments, it might be prudent to check periodically for a change of date)

The public meeting will be held on March 23, 2016, 9:00 a.m.-3:00 p.m. Eastern Time, or after the last public commenter has spoken, whichever occurs first. Comments must be received on or before March 21, 2016.

ADDRESSES:
The public meeting will be held at the NIOSH/CDC Robert A. Taft Laboratories, Auditorium, 1150 Tusculum Avenue, Cincinnati, Ohio 45226.

FOR FURTHER INFORMATION CONTACT:
Charles Geraci, NIOSH, Education and Information Division, Nanotechnology Research Center, Robert A. Taft Laboratories, 1090 Tusculum Avenue, Cincinnati, OH 45226, (513) 533-8339 (not a toll free number).

SUPPLEMENTARY INFORMATION:
I. Background: To discuss and obtain comments on the draft document, “NIOSH Current Intelligence Bulletin: Health Effects of Occupational Exposure to Silver Nanomaterials”. Special emphasis will be placed on discussion of the following:

Whether the health hazard identification, risk estimation, and discussion of health effects of silver and silver nanomaterials are a reasonable reflection of the current understanding of the scientific literature;
Workplaces and occupations where exposure to silver and silver nanomaterials may occur; and studies on health effects associated with occupational exposure to silver dust and fume;
Current strategies for controlling or preventing exposure to silver and silver nanomaterials (e.g., engineering controls, work practices, personal protective equipment);
Current exposure measurement methods and challenges in measuring workplace exposures to silver nanomaterials; and
Areas for future collaborative efforts (e.g., research, communication, development of exposure measurement and control strategies).

II. Public Meeting: NIOSH will hold a public meeting on the NIOSH Draft Current Intelligence Bulletin: Health Effects of Occupational Exposure to Silver Nanomaterials to allow commenters to provide oral comments on the draft document, to inform NIOSH about additional relevant data or information, and to ask questions on the draft document and NIOSH recommendations.

The forum will include scientists and representatives from various government agencies, industry, labor, and other stakeholders, and is open to the public. Attendance is limited only by the space available. The meeting room accommodates 100 people. The meeting will be open to limited number of participants through a conference call phone number and Webcast live on the Internet. Due to the limited spaces, notification of intent to attend the meeting must be made to the NIOSH Docket Office, at nioshdocket@cdc.gov, (513) 533-8611, or fax (513) 533-8285, no later than March 9, 2016. Priority for attendance will be given to those providing oral comments. Other requests to attend the meeting will then be accommodated on a first-come, first-served basis.

Registration is required. Because this meeting is being held at a Federal site, pre-registration is required on or before March 9, 2016 and a government-issued photo ID (driver’s license, military ID or passport) will be required to obtain entrance to the facility. There will be an airport type security check. Non‐US citizens need to register by February 12, 2016 to allow sufficient time for mandatory facility security clearance procedures to be completed. Additional personal information will be required. This information will be transmitted to the CDC Security Office for approval. An email confirming registration will be sent from NIOSH for both in-person participation and audio conferencing participation.

Oral presentations will be limited to 15 minutes per presenter. If additional time becomes available, presenters will be notified. All requests to present should contain the name, address, telephone number, and relevant business affiliations of the presenter, topic of the presentation, and the approximate time requested for the presentation. An email confirming registration will be sent from the NIOSH Docket Office and will include details needed to participate. Oral comments given at the meeting will be recorded and included in the NIOSH Docket 260-A.

After reviewing the requests for presentations, NIOSH will notify the presenter that his/her presentation is scheduled. If a participant is not in attendance when his/her presentation is scheduled to begin, the remaining participants will be heard in order. After the last scheduled speaker is heard, participants who missed their assigned times may be allowed to speak, limited by time available.

Attendees who wish to speak but did not submit a request for the opportunity to make a presentation may be given this opportunity after the scheduled speakers are heard, at the discretion of the presiding officer and limited by time available.

You may submit comments, identified by CDC-2016-0001 and NIOSH 260-A, by either of the following methods:

Federal eRulemaking Portal: www.regulations.gov. Follow the instructions for submitting comments.
Mail: National Institute for Occupational Safety and Health, NIOSH Docket Office, 1090 Tusculum Avenue, MS C-34, Cincinnati, Ohio 45226-1998.

Instructions: All information received in response to this notice must include the agency name and docket number [CDC-2016-0001; NIOSH 260-A]. All relevant comments received will be posted without change to www.regulations.gov including any personal information provided. All information will be available for public examination and copying at the NIOSH Docket Office, 1150 Tusculum Avenue, Room 155, Cincinnati, Ohio 45226.

Non-U.S. Citizens: Because of CDC Security Regulations, any non-U.S. citizen wishing to attend this meeting must provide the following information in writing to the NIOSH Docket Officer at the address below no later than February 12, 2016 [emphasis mine].

Name:

Gender:

Date of Birth:

Place of Birth (city, province, state, country):

Citizenship:

Passport Number:

Date of Passport Issue:

Date of Passport Expiration:

Type of Visa:

U.S. Naturalization Number (if a naturalized citizen):

U.S. Naturalization Date (if a naturalized citizen):

Visitor’s Organization:

Organization Address:

Organization Telephone Number:

Visitor’s Position/Title within the Organization:

This information will be transmitted to the CDC Security Office for approval. Visitors will be notified as soon as approval has been obtained.

H/T Safety + Health; The Official Magazine of the NSC Congress & Expo, Feb. 10, 2016 news item for the information about the original January 2016 notice.

Québec’s second edition of its Best Practices Guidance for Nanomaterial Risk Management in the Workplace

Lynn Bergeson’s Dec. 16, 2015 posting on Nanotechnology Now highlights Québec’s second edition of its guide to best practices for handling nanomaterials in the workplace,

On December 11, 2015, the Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST), a leading occupational health and safety research center in Canada, published the second edition of its Best Practices Guidance for Nanomaterial Risk Management in the Workplace.

… IRSST intends the Guidance to support the safe development of nanotechnologies in Québec by bringing together current scientific knowledge on hazard identification, strategies for determining nanomaterial levels in different work environments, risk assessment, and the application of various risk management approaches. IRSST states that the Guidance provides practical information and prevention tools for the safe handling of nanomaterials in laboratories and pilot plants, as well as industrial facilities that produce or incorporate them. The Guidance recommends a preventive approach designed to minimize occupational exposure to nanomaterials. According to IRSST, given the different exposure pathways, the many factors that can affect nanomaterial toxicity and the health risks, its approach “is essentially based on hazard identification, different risk assessment strategies and a hierarchy of control measures, incorporating knowledge specific to nanomaterials when available.” The second edition of the Guidance incorporates new information in the scientific literature. In addition, IRSST has included appendices describing initiatives in Québec workplaces; examples of at-risk situations described in the literature; preventive measures and data on their relative efficacy; and the implementation of measures to control exposure. ,,,

The Best Practices Guidance for Nanomaterial Risk Management in the Workplace can be found here on the IRSST website where you’ll also find this description,

Today’s nanotechnologies can substantially improve the properties of a wide range of products in all sectors of activity, from the manufacture of materials with ground-breaking performance to medical diagnostics and treatment—yet they raise major technological, economic, ethical, social and environmental questions. Some of the spinoffs we can expect include the emergence of new markets, job creation, improvements in quality of life and contributions to protection of the environment. The impact of nanotechnologies is already being felt in sectors as diverse as agroprocessing, cosmetics, construction, healthcare and the aerospace industry. Most universities in Québec and many research centres are working to design new applications. Many companies have projects in the start-up phase, while others are already producing nanomaterials or have incorporated them in their processes to improve product performance, a trend expected to accelerate over the coming years. These new developments, which could mean exposure of a growing number of workers to these infinitesimally small particles, are of particular concern to workers in industry and staff in research laboratories. It is estimated that in 2015 about 10% of manufacturing jobs worldwide will be associated with nanotechnologies, [emphasis mine] and more than 2,000 commercial products will contain nanomaterials.

Given our fragmentary knowledge of the health and safety risks for workers and the environment, the handling of these new materials with their unique properties raises many questions and concerns. In fact, many studies have already demonstrated that the toxicity of certain nanomaterials differs from that of their bulk counterparts of the same chemical composition. Nanomaterials enter the body mainly through inhalation but also through the skin and the GI tract. Animal studies have demonstrated that certain nanomaterials can enter the blood stream through translocation and accumulate in different organs. Animal studies also show that certain nanomaterials cause more inflammation and more lung tumours on a mass-for-mass basis than the same substances in bulk form, among many other specific effects documented. In addition, research has shown that the physicochemical characteristics of nanomaterials (size, shape, specific surface area, charge, solubility and surface properties) play a major role in their impact on biological systems, including their ability to generate oxidative stress. It is thus crucial that risks be assessed and controlled to ensure the safe handling of nanomaterials. As with many other chemicals, a risk assessment and management approach must be developed on a case-by-case basis.

There is still no consensus, however, on a measurement method for characterizing occupational exposure to nanomaterials, making quantitative risk assessment difficult if not impossible in many situations. As a result, a precautionary approach is recommended to minimize worker exposure. In Québec, the employer is responsible for providing a safe work environment, and preventive measures must be applied by employees. Accordingly, preventive programs that take into account the specific characteristics of nanomaterials must be developed in all work environments where nanomaterials are handled, so that good work practices can be established and preventive procedures tailored to the risks of the particular work situation can be introduced.

Fortunately, current scientific knowledge, though partial, makes it possible to identify, assess and effectively manage these risks. This best practices guide is meant to support the safe development of nanotechnologies in Québec by bringing together current scientific knowledge on hazard identification, strategies for determining nanomaterial levels in different work environments, risk assessment and the application of various risk management approaches. Some knowledge of occupational hygiene is required to use this guide effectively. Designed for all work environments that manufacture or use nanomaterials, this guide provides practical information and prevention tools for the safe handling of nanomaterials in laboratories and pilot plants as well as industrial facilities that produce or incorporate them. To be effective, risk management must be an integral part of an organization’s culture, and health and safety issues must be considered when designing the workplace or as far upstream as possible. This is crucial for good organizational governance. In practice, risk management is an iterative process implemented as part of a structured approach that fosters continuous improvement in decision-making and can even promote better performance. The purpose of this guide is to contribute to the implementation of such an approach to the prevention of nanomaterial-related risks only. Depending on the process, other risks (associated with exposure to solvents, gas, heat stress, ergonomic stress, etc.) may be present, but they are not addressed in this guide.

I wonder where they got these numbers, “It is estimated that in 2015 about 10% of manufacturing jobs worldwide will be associated with nanotechnologies, and more than 2,000 commercial products will contain nanomaterials.” Given that many companies don’t like to disclose whether or not they’re using nanomaterials and most countries don’t insist on an inventory (there are voluntary inventories, which generally speaking have not been successful), bringing me back to the question: where did these numbers come from?

As for the guide itself, Canadians have been very involved with the OECD (Organization for Economic Cooperation and Development) and its ‘nanomaterial safety’ working group and, I understand, have provided leadership on occasion. The guide, which is available in both French and English, is definitely worth checking out.

Titanium dioxide nanoparticles and the brain

This research into titanium dioxide nanoparticles and possible effects on your brain should they pass the blood-brain barrier comes from the University of Nebraska-Lincoln (US) according to a Dec. 15, 2015 news item on Nanowerk (Note: A link has been removed),

Even moderate concentrations of a nanoparticle used to whiten certain foods, milk and toothpaste could potentially compromise the brain’s most numerous cells, according to a new study from the University of Nebraska-Lincoln (Nanoscale, “Mitochondrial dysfunction and loss of glutamate uptake in primary astrocytes exposed to titanium dioxide nanoparticles”).

A Dec. 14, 2015 University of Nebraska-Lincoln news release, which originated the news item, provides more detail (Note: Links have been removed),

The researchers examined how three types of titanium dioxide nanoparticles [rutile, anatase, and commercially available P25 TiO2 nanoparticles], the world’s second-most abundant nanomaterial, affected the functioning of astrocyte cells. Astrocytes help regulate the exchange of signal-carrying neurotransmitters in the brain while also supplying energy to the neurons that process those signals, among many other functions.

The team exposed rat-derived astrocyte cells to nanoparticle concentrations well below the extreme levels that have been shown to kill brain cells but are rarely encountered by humans. At the study’s highest concentration of 100 parts per million, or PPM, two of the nanoparticle types still killed nearly two-thirds of the astrocytes within a day. That mortality rate fell to between half and one-third of cells at 50 PPM, settling to about one-quarter at 25 PPM.

Yet the researchers found evidence that even surviving cells are severely impaired by exposure to titanium dioxide nanoparticles. Astrocytes normally take in and process a neurotransmitter called glutamate that plays wide-ranging roles in cognition, memory and learning, along with the formation, migration and maintenance of other cells.

When allowed to accumulate outside cells, however, glutamate becomes a potent toxin that kills neurons and may increase the risk of neurodegenerative diseases such as Alzheimer’s and Parkinson’s. The study reported that one of the nanoparticle types reduced the astrocytes’ uptake of glutamate by 31 percent at concentrations of just 25 PPM. Another type decreased that uptake by 45 percent at 50 PPM.

The team further discovered that the nanoparticles upset the intricate balance of protein dynamics occurring within astrocytes’ mitochondria, the cellular organelles that help regulate energy production and contribute to signaling among cells. Titanium dioxide exposure also led to other signs of mitochondrial distress, breaking apart a significant proportion of the mitochondrial network at 100 PPM.

“These events are oftentimes predecessors of cell death,” said Oleh Khalimonchuk, a UNL assistant professor of biochemistry who co-authored the study. “Usually, people are looking at those ultimate consequences, but what happens before matters just as much. Those little damages add up over time. Ultimately, they’re going to cause a major problem.”

Khalimonchuk and fellow author Srivatsan Kidambi, assistant professor of chemical and biomolecular engineering, cautioned that more research is needed to determine whether titanium dioxide nanoparticles can avoid digestion and cross the blood-brain barrier that blocks the passage of many substances. [emphasis mine]

However, the researchers cited previous studies that have discovered these nanoparticles in the brain tissue of animals with similar blood-brain barriers. [emphasis mine] The concentrations of nanoparticles found in those specimens served as a reference point for the levels examined in the new study.

“There’s evidence building up now that some of these particles can actually cross the (blood-brain) barrier,” Khalimonchuk said. “Few molecules seem to be able to do so, but it turns out that there are certain sites in the brain where you can get this exposure.”

Kidambi said the team hopes the study will help facilitate further research on the presence of nanoparticles in consumer and industrial products.

“We’re hoping that this study will get some discussion going, because these nanoparticles have not been regulated,” said Kidambi, who also holds a courtesy appointment with the University of Nebraska Medical Center. “If you think about anything white – milk, chewing gum, toothpaste, powdered sugar – all these have nanoparticles in them.

“We’ve found that some nanoparticles are safe and some are not, so we are not saying that all of them are bad. Our reasoning is that … we need to have a classification of ‘safe’ versus ‘not safe,’ along with concentration thresholds (for each type). It’s about figuring out how the different forms affect the biology of cells.

I notice the researchers are being careful about alarming anyone unduly while emphasizing the importance of this research. For anyone curious enough to read the paper, here’s a link to and a citation for it,

Mitochondrial dysfunction and loss of glutamate uptake in primary astrocytes exposed to titanium dioxide nanoparticles by Christina L. Wilson, Vaishaali Natarajan, Stephen L. Hayward, Oleh Khalimonchuk and   Srivatsan Kidambi. Nanoscale, 2015,7, 18477-18488 DOI: 10.1039/C5NR03646A First published online 31 Jul 2015

This is paper is open access although you may need to register on the site.

Final comment, I note this was published online way back in July 2015. Either the paper version of the journal was just published and that’s what’s being promoted or the media people thought they’d try to get some attention for this work by reissuing the publicity. Good on them! It’s hard work getting people to notice things when there is so much information floating around.

Managing risks in a world of converging technology (the fourth industrial revolution)

Finally there’s an answer to the question: What (!!!) is the fourth industrial revolution? (I took a guess [wrongish] in my Nov. 20, 2015 post about a special presentation at the 2016 World Economic Forum’s IdeasLab.)

Andrew Maynard in a Dec. 3, 2015 think piece (also called a ‘thesis’) for Nature Nanotechnology answers the question,

… an approach that focuses on combining technologies such as additive manufacturing, automation, digital services and the Internet of Things, and … is part of a growing movement towards exploiting the convergence between emerging technologies. This technological convergence is increasingly being referred to as the ‘fourth industrial revolution’, and like its predecessors, it promises to transform the ways we live and the environments we live in. (While there is no universal agreement on what constitutes an ‘industrial revolution’, proponents of the fourth industrial revolution suggest that the first involved harnessing steam power to mechanize production; the second, the use of electricity in mass production; and the third, the use of electronics and information technology to automate production.)

In anticipation of the the 2016 World Economic Forum (WEF), which has the fourth industrial revolution as its theme, Andrew  explains how he sees the situation we are sliding into (from Andrew Maynard’s think piece),

As more people get closer to gaining access to increasingly powerful converging technologies, a complex risk landscape is emerging that lies dangerously far beyond the ken of current regulations and governance frameworks. As a result, we are in danger of creating a global ‘wild west’ of technology innovation, where our good intentions may be among the first casualties.

There are many other examples where converging technologies are increasing the gap between what we can do and our understanding of how to do it responsibly. The convergence between robotics, nanotechnology and cognitive augmentation, for instance, and that between artificial intelligence, gene editing and maker communities both push us into uncertain territory. Yet despite the vulnerabilities inherent with fast-evolving technological capabilities that are tightly coupled, complex and poorly regulated, we lack even the beginnings of national or international conceptual frameworks to think about responsible decision-making and responsive governance.

He also lists some recommendations,

Fostering effective multi-stakeholder dialogues.

Encouraging actionable empathy.

Providing educational opportunities for current and future stakeholders.

Developing next-generation foresight capabilities.

Transforming approaches to risk.

Investing in public–private partnerships.

Andrew concludes with this,

… The good news is that, in fields such as nanotechnology and synthetic biology, we have already begun to develop the skills to do this — albeit in a small way. We now need to learn how to scale up our efforts, so that our convergence in working together to build a better future mirrors the convergence of the technologies that will help achieve this.

It’s always a pleasure to read Andrew’s work as it’s thoughtful. I was surprised (since Andrew is a physicist by training) and happy to see the recommendation for “actionable empathy.”

Although, I don’t always agree with him on this occasion I don’t have any particular disagreements but I think that including a recommendation or two to cover the certainty we will get something wrong and have to work quickly to right things would be a good idea.  I’m thinking primarily of governments which are notoriously slow to respond with legislation for new developments and equally slow to change that legislation when the situation changes.

The technological environment Andrew is describing is dynamic, that is fast-moving and changing at a pace we have yet to properly conceptualize. Governments will need to change so they can respond in an agile fashion. My suggestion is:

Develop policy task forces that can be convened in hours and given the authority to respond to an immediate situation with oversight after the fact

Getting back to Andrew Maynard, you can find his think piece in its entirety via this link and citation,

Navigating the fourth industrial revolution by Andrew D. Maynard. Nature Nanotechnology 10, 1005–1006 (2015) doi:10.1038/nnano.2015.286 Published online 03 December 2015

This paper is behind a paywall.

What is the effect of nanoscale plastic on marine life?

A Nov.27, 2015 news item on Nanowerk announces a new UK (United Kingdom) research project designed to answer the question: what impact could nanoscale plastic particles  have on the marine environment?,

As England brings in pricing on plastic carrier bags, and Scotland reveals that similar changes a little over a year ago have reduced the use of such bags by 80%, new research led by Heriot-Watt University in conjunction with Plymouth University will look at the effect which even the most microscopic plastic particles can have on the marine environment.

While images of large ‘islands’ of plastic rubbish or of large marine animals killed or injured by the effects of such discards have brought home some of the obvious negative effects of plastics in the marine environment, it is known that there is more discarded plastic out there than we can account for, and much of it will have degraded into small or even microscopic particles.

It is the effect of these latter, known as nano-plastics, which will be studied under a £1.1m research project, largely funded by NERC [UK Natural Environment Research Council] and run by Heriot-Watt and Plymouth Universities.

A Nov. 25, 2015 Herriot-Watt University press release, which originated the news item, provides more details,

The project, RealRiskNano, will look at the risks these tiny plastic particles pose to the food web including filter-feeding organisms like mussels, clams and sediment dwelling organisms. It will focus on providing information to improve environmental risk assessment for nanoplastics, based on real-world exposure scenarios replicated in the laboratory.

Team leader Dr Theodore Henry, Associate Professor of Toxicology at Heriot-Watt’s School of Life Sciences, said that the study will build on previous research on nano-material toxicology, but will provide information which the earlier studies did not include.

“Pieces of plastic of all sizes have been found in even the most remote marine environments. It’s relatively easy to see some of the results: turtles killed by easting plastic bags which they take for jelly fish, or large marine mammals drowned when caught in discarded ropes and netting.

“But when plastics fragment into microscopic particles, what then? It’s easy to imagine that they simply disappear, but we know that nano-particles pose their own distinct threats purely because of their size. They’re small enough to be transported throughout the environment with unknown effects on organisms including toxicity and interference with processes of the digestive system.

An important component of the project, to be investigated by Dr Tony Gutierrez at Heriot-Watt, will be the study of interactions between microorganisms and the nanoplastics to reveal how these interactions affect their fate and toxicology.

The aim, said Dr Henry, is to provide the information which is needed to effect real change.“We simply don’t know what effects these nano-plastic particles may pose to the marine environment, to filter-feeders and on to fish, and through the RealRiskNano project we aim to provide this urgently needed information to the people whose job it is to assess risk to the marine ecosystem and decide what steps need to be taken to mitigate it.”

You can find the RealRiskNano website here.

An app for nanomaterial risks (NanoRisk)

It seems past time for someone to have developed an app for nanomaterial risks. A Nov. 12, 2015 news item on Nanowerk makes the announcement (Note: A link has been removed),

The NanoRisk App is a guide to help the researcher in the risk assessment of nanomaterials. This evaluation is determined based on the physicochemical characteristics and the activities to be carried out by staff in research laboratories.

The NanoRisk App was developed at the University of Los Andes or Universidad de los Andes in Colombia (there also seems to be one in Chile). From the Nano Risk App homepage,

The NanoRisk App application was developed at the University of Los Andes by the Department of Chemical Engineering and the Department of Electrical and Electronic Engineering, Faculty of Engineering and implemented in cooperation with the Department of Occupational Health at the University of Los Andes. This application focuses on the use of manufactured nanomaterials.

Authors

Homero Fernando Pastrana Rendón MD, MsC, PhD Candidate. Alba Graciela Ávila, Associate Professor, Department of Electrical and Electronic Engineering. Felipe Muñoz Giraldo, Professor Associate Professor, Department of Chemical Engineering, University of Los Andes.

Acknowledgements to Diego Angulo and Diana Fernandez, from the Imagine group, for all the support in the development of this application.

About the App

The app is a guide to help the researcher in the risk assessment of nanomaterials. This evaluation is determined based on the physicochemical characteristics and the activities to be carried out by staff in research laboratories. This is based on nano risk management strategies from various institutions such as the National Institute for Occupational Safety and Health, U.S. (NIOSH), the New Development Organization of Japan Energy and Industrial Technology (NEDO), the European Commission (Nanosafe Program) and the work developed by the Lawrence Livermore National Laboratory (California, USA) in conjunction with the Safety Science Group at the University of Delft in the Netherlands.

RESULT:

The app will estimates the risk at four levels (low, medium, high and very high) for the hazard of the nanomaterial and the probability to be exposed to the material. Then it will recommend measures to contain the risk by applying engineering measures (controlled ventilation system, biosafety cabinet and glovebox).

They have a copyright notice on the page, as well as, instructions on how to access the App and the information.