Category Archives: regulation

Building a regulatory framework for nanotechnology in India

For the second time in less than six weeks (the first time is described in my June 13, 2016 posting on India’s draft guidelines for the safe handling of nanomaterials) I’ve stumbled across an article about the need for more nanotechnology safety measures in India. From a June 23, 2016 article by Prateek Sibal for The Wire (Note: Links have been removed),

India ranks third in the number of research publications in nanotechnology, only after China and the US. This significant share in global nanotech research is a result of sharp focus by the Department of Science and Technology (DST) to research in the field in the country. The unprecedented funding of Rs 1,000 crore for the Nano Mission was clearly dictated by the fact that India had missed the bus on the micro-electronic revolution of the 1970s and its attendant economic benefits that countries like China, Taiwan and South Korea continue to enjoy to this day.

At the same time, the success of the Nano Mission is not limited to research but also involves training the required human resource for further advancement in the field. An ASSOCHAM and TechSci Research study reported in 2014: “From 2015 onwards, global nanotechnology industry would require about two million professionals and India is expected to contribute about 25% professionals in the coming years.”

A missing element in India’s march towards becoming a nanotechnology powerhouse is the lack of focus on risk analysis and regulation. A survey of Indian practitioners working in the area of nano-science and nanotechnology research showed that 95% of the practitioners recognised ethical issues in nanotech research. Some of these concerns relate to the possibly adverse effects of nanotechnology on the environment and humans, their use as undetectable weapon in warfare, and the incorporation of nano-devices as performance enhancers in human beings.

One reason for lack of debate around ethical, and public-health and -safety, concerns around new technologies could be the exalted status that science and its practitioners enjoy in the country. A very successful space program and a largely indigenous nuclear program has ensured that policymakers spend much of their time feting achievements of Indian science than discussing the risks associated with new technologies or improving regulation.

After describing some of the studies raising health concerns, Sibal describes the issue for policymakers (Note: Links have been removed),

The challenge that remains in front of policymakers is that of regulating a field where vast areas of knowledge are still being investigated and are unknown. In this situation, over-regulation may end up stifling further development while under-regulation could expose the public to adverse health effects. Further, India’s lack of investment in risk studies only sustains the lull in the policy establishment when it comes to nanotech regulations.

The Energy and Resources Institute has extensively studied regulatory challenges posed by nanotechnology and advocates that an “incremental approach holds out some promise and offers a reconciliation between the two schools- one advocating no regulation at present given the uncertainty and the other propounding a stand-alone regulation for nanotechnology.”

Kesineni Srinivas, the Member of Parliament from Vijayawada, has taken cognisance of the need for incremental regulation in nanotechnology from the view point of public health and safety. (Disclosure: The author worked with the Vijayawada MP on drafting the legislation on nanotechnology regulation, introduced in the winter session of Parliament, 2015.)

In December 2015, Srinivas introduced the Insecticides (Amendment) Bill in the Lok Sabha to grant only a provisional registration to insecticides containing nanoparticles with a condition that “it shall be mandatory for the manufacturer or importer to report any adverse impact of the insecticide on humans and environment in a manner specified by the Registration Committee.” This is an improvement over the earlier process of granting permanent registration to insecticides. However, the fate of the bill remains uncertain as only 14 private member bills have been passed in Parliament since the first Lok Sabha in 1952.

Prateek Sibal will be joining Sciences Po (the Paris Institute of Political Sciences), Paris, as a Charpak Scholar in 2016.

I always appreciate these pieces as they help me to adjust my Canada-, US-, Commonwealth- and European-centric views.

Introducing the LIFE project NanoMONITOR

I believe LIFE in the project title refers to life cycle. Here’s more from a June 9, 2016 news item from Nanowerk (Note: A link has been removed),

The newly started European Commission LIFE project NanoMONITOR addresses the challenges of supporting the risk assessment of nanomaterials under REACH by development of a real-time information and monitoring system. At the project’s kickoff meeting held on the 19th January 2016 in Valencia (Spain) participants discussed how this goal could be achieved.

Despite the growing number of engineered nanomaterials (ENMs) already available on the market and in contract to their benefits the use, production, and disposal of ENMs raises concerns about their environmental impact.

A REACH Centre June 8, 2016 press release, which originated the news item, expands on the theme,

Within this context, the overall aim of LIFE NanoMONITOR is to improve the use of environmental monitoring data to support the implementation of REACH regulation and promote the protection of human health and the environment when dealing with ENMs. Within the EU REACH Regulation, a chemical safety assessment report, including risk characterisation ratio (RCR), must be provided for any registered ENMs. In order to address these objectives, the project partners have developed a rigorous methodology encompassing the following aims:

  • Develop a novel software application to support the acquisition, management and processing of data on the concentration of ENMs.
  • Develop an on-line environmental monitoring database (EMD) to support the sharing of information.
  • Design and develop a proven monitoring station prototype for continuous monitoring of particles below 100 nm in air (PM0.1).
  • Design and develop standardized sampling and data analysis procedures to ensure the quality, comparability and reliability of the monitoring data used for risk assessment.
  • Support the calculation of the predicted environmental concentration (PEC) of ENMs in the context of REACH.

Throughout the project’s kick off meeting, participants discussed the status of the research area, project goals, and expectations of the different stakeholders with respect to the project outcome.

The project has made this graphic available,

LIFE_NanoMONITOR

You can find the LIFE project NanoMONITOR website here.

India’s draft guidelines for the safe handling of nanomaterials

I believe this is the first time I’ve seen any guidelines for the safe handling of nanomaterials that are neither from Europe nor from the US. I imagine that’s due to translation issues or lack of publicity rather than a failure to create guidelines.

In any event, Indrani Barpujari, Advisor (Governance) at the Atal Bihari Vajpayee Institute of Good Governance and Policy Analysis, Bhopal, India, has written a commentary on draft regulations for India (from her Draft Guidelines for Safe Handling of Nanomaterials commentary in Economic and Political Weekly, Vol. 51, Issue No. 23, 04 Jun, 2016 ISSN [Online] – 2349-8846 [appears to be open access]),

It is indeed laudable that as a first step towards regulation of nanotechnology in India, the Nano Mission under the Department of Science and Technology has come out with the draft “Guidelines and Best Practices for Safe Handling of Nanomaterials in Research Laboratories and Industries.” Taking cognisance of the imperative for safe handling of nanomaterials, the Nano Mission has constituted a task force consisting of eminent experts who have prepared this document. Involving the control of matter at the nanoscale, nanomaterials are characterised by small dimensions, large surface area, and high reactivity which while making them amenable to a large variety of applications in various sectors also render them potentially dangerous for human health and environmental safety, with considerable scientific uncertainty regarding the risks. Nanotechnology presents before policymakers a classic case of “Collingridge dilemma” or a “dilemma of control” with policy decisions required to be taken on the basis of uncertain scientific facts and under conditions of some urgency. It is the unique combination of “high expectations and huge uncertainties” (Van Lente 2010) associated with nanotechnology which has provided the required thrust for the current guidelines.

The draft guidelines, basically intended as standard operating procedure (SOP) for handling nanomaterials in research laboratories and industries, prescribe a combination of engineering controls, work practices and personal protective equipment as part of a robust exposure control strategy. These lay down the process for identifying hazards, taking note of the specific effect of surface chemistry, shape, size and morphology on toxicity caused to various organs. These address the potential exposure pathways and concomitant safety measures to mitigate the same. While prescribing certain best practices for handling nanomaterials generally, the guidelines also lay down another set of best practices specifically pertaining to the making and handling of nanopowders and use of products relating to food and healthcare. A precautionary approach is advocated with detailed life cycle assessment and strong binding procedures with respect to stakeholder involvement for various players while formulating best practices in the food sector particularly.

While the draft guidelines as a first step cover reasonable ground, it may be relevant to look at these in the context of the discourse on nanotechnology regulation abroad as well as in India. The focus of modern “risk societies” being more on “manufactured risks” or risks which are the product of human activity (Giddens 1999), governments, particularly in the developed world, are increasingly realising the need for risk-based regulation, to address potential risks from emerging technologies like nanotechnology, while promoting their development. Preliminary steps have been taken to regulate nanotechnology despite the admitted difficulty in doing so owing to the scientific uncertainty regarding its risks and limited amenability to traditional risk management approaches (Schummer and Pariotti 2008).

Thus, it may be surmised that the developed world’s engagement with nanotechnology to harness its benefits has been characterised by an almost unprecedented focus on regulating its risks and developing an anticipatory governance framework, taking on board different stakeholders including the public and incorporating societal concerns. On the other hand, with an almost single-minded focus on promotion in the initial years, the official pursuit of nanotechnology in India has not accorded much priority to its potential risks with the result than a large number of nano-based products are already out in the markets, without any regulation (Barpujari 2011a). In India, the government is the primary promoter of nanotechnology, pursued under the mission on nanoscience and technology (Nano Mission) with a huge budget outlay targeted at the development of nano-applications and creating adequate infrastructural and human capabilities for this purpose.

The Indian scientific establishment has high expectations from nanotechnology, with the technology expected to help meet the development needs of the country, while also positioning India as a forerunner in the global arena. Srivastava and Chowdhury (2008) observe that Indian scientists at the helm of affairs perceive that Indian science should not lose out on this opportunity to establish itself as a global leader and that it should not “miss the bus” as it did during the previous semiconductor revolution. Sahoo and Deshpande Sarma’s (2010) survey on risk perceptions among thirty scientists working in public-funded scientific institutions/laboratories indicate that Indian scientists are not very much perturbed by the risks of nanotechnology, and few take special precautions while working with nanomaterials, while very few are interested in taking up risk research.

The fact that the policy establishment is yet to take into serious consideration the potential risks of the technology is also evident from the low priority accorded to risk research, which should precede regulation. A very small number of projects are being publicly funded to look into toxicity issues, and there is almost no engagement with the social sciences and humanities, as evidenced by the lack of government funding for such studies.

At the same time, it must be acknowledged that different stakeholders in India particularly policy researchers, civil society actors and research institutions pursuing risk research have been persistently making the case for nanotechnology regulation in the country and taken the lead in charting the way ahead. It is acknowledged that problems in developing risk-based regulation are particularly compounded for a developing country like India, owing to a lack of resources, expertise and regulatory mandate. The absence of regulation, it is anticipated, would be even worse as in the event of some of the risks materialising, developing countries would be ill-equipped to handle and mitigate these (Barpujari 2011b).

Particularly noteworthy is a regulatory matrix for India developed by TERI [The Energy and Resources Institute] (2009) comprising several central legislation, rules and notifications which could have relevance for regulation of environmental risks, occupational health and safety risks arising from nanotechnology development and applications in India. Another report (TERI 2012) has provided leads for adopting a precautionary approach and developing an anticipatory regulatory framework for nanotechnology in the South Asian region, taking the particular case of India, Pakistan and Sri Lanka.

Vajpayee offers more insight with her suggestions for “The Way Ahead” and I strongly suggest reading her commentary if you’re interested in a perspective from South Asia. There’s also a list of references at the end of the commentary, should you wish to explore further.

Nanoparticles in baby formula

Needle-like particles of hydroxyapatite found in infant formula by ASU researchers. Westerhoff and Schoepf/ASU, CC BY-ND

Needle-like particles of hydroxyapatite found in infant formula by ASU [Arizona State University] researchers. Westerhoff and Schoepf/ASU, CC BY-ND

Nanowerk is featuring an essay about hydroxyapatite nanoparticles in baby formula written by Dr. Andrew Maynard in a May 17, 2016 news item (Note: A link has been removed),

There’s a lot of stuff you’d expect to find in baby formula: proteins, carbs, vitamins, essential minerals. But parents probably wouldn’t anticipate finding extremely small, needle-like particles. Yet this is exactly what a team of scientists here at Arizona State University [ASU] recently discovered.

The research, commissioned and published by Friends of the Earth (FoE) – an environmental advocacy group – analyzed six commonly available off-the-shelf baby formulas (liquid and powder) and found nanometer-scale needle-like particles in three of them. The particles were made of hydroxyapatite – a poorly soluble calcium-rich mineral. Manufacturers use it to regulate acidity in some foods, and it’s also available as a dietary supplement.

Andrew’s May 17, 2016 essay first appeared on The Conversation website,

Looking at these particles at super-high magnification, it’s hard not to feel a little anxious about feeding them to a baby. They appear sharp and dangerous – not the sort of thing that has any place around infants. …

… questions like “should infants be ingesting them?” make a lot of sense. However, as is so often the case, the answers are not quite so straightforward.

Andrew begins by explaining about calcium and hydroxyapatite (from The Conversation),

Calcium is an essential part of a growing infant’s diet, and is a legally required component in formula. But not necessarily in the form of hydroxyapatite nanoparticles.

Hydroxyapatite is a tough, durable mineral. It’s naturally made in our bodies as an essential part of bones and teeth – it’s what makes them so strong. So it’s tempting to assume the substance is safe to eat. But just because our bones and teeth are made of the mineral doesn’t automatically make it safe to ingest outright.

The issue here is what the hydroxyapatite in formula might do before it’s digested, dissolved and reconstituted inside babies’ bodies. The size and shape of the particles ingested has a lot to do with how they behave within a living system.

He then discusses size and shape, which are important at the nanoscale,

Size and shape can make a difference between safe and unsafe when it comes to particles in our food. Small particles aren’t necessarily bad. But they can potentially get to parts of our body that larger ones can’t reach. Think through the gut wall, into the bloodstream, and into organs and cells. Ingested nanoscale particles may be able to interfere with cells – even beneficial gut microbes – in ways that larger particles don’t.

These possibilities don’t necessarily make nanoparticles harmful. Our bodies are pretty well adapted to handling naturally occurring nanoscale particles – you probably ate some last time you had burnt toast (carbon nanoparticles), or poorly washed vegetables (clay nanoparticles from the soil). And of course, how much of a material we’re exposed to is at least as important as how potentially hazardous it is.

Yet there’s a lot we still don’t know about the safety of intentionally engineered nanoparticles in food. Toxicologists have started paying close attention to such particles, just in case their tiny size makes them more harmful than otherwise expected.

Currently, hydroxyapatite is considered safe at the macroscale by the US Food and Drug Administration (FDA). However, the agency has indicated that nanoscale versions of safe materials such as hydroxyapatite may not be safe food additives. From Andrew’s May 17, 2016 essay,

Hydroxyapatite is a tough, durable mineral. It’s naturally made in our bodies as an essential part of bones and teeth – it’s what makes them so strong. So it’s tempting to assume the substance is safe to eat. But just because our bones and teeth are made of the mineral doesn’t automatically make it safe to ingest outright.

The issue here is what the hydroxyapatite in formula might do before it’s digested, dissolved and reconstituted inside babies’ bodies. The size and shape of the particles ingested has a lot to do with how they behave within a living system. Size and shape can make a difference between safe and unsafe when it comes to particles in our food. Small particles aren’t necessarily bad. But they can potentially get to parts of our body that larger ones can’t reach. Think through the gut wall, into the bloodstream, and into organs and cells. Ingested nanoscale particles may be able to interfere with cells – even beneficial gut microbes – in ways that larger particles don’t.These possibilities don’t necessarily make nanoparticles harmful. Our bodies are pretty well adapted to handling naturally occurring nanoscale particles – you probably ate some last time you had burnt toast (carbon nanoparticles), or poorly washed vegetables (clay nanoparticles from the soil). And of course, how much of a material we’re exposed to is at least as important as how potentially hazardous it is.Yet there’s a lot we still don’t know about the safety of intentionally engineered nanoparticles in food. Toxicologists have started paying close attention to such particles, just in case their tiny size makes them more harmful than otherwise expected.

Putting particle size to one side for a moment, hydroxyapatite is classified by the US Food and Drug Administration (FDA) as “Generally Regarded As Safe.” That means it considers the material safe for use in food products – at least in a non-nano form. However, the agency has raised concerns that nanoscale versions of food ingredients may not be as safe as their larger counterparts.Some manufacturers may be interested in the potential benefits of “nanosizing” – such as increasing the uptake of vitamins and minerals, or altering the physical, textural and sensory properties of foods. But because decreasing particle size may also affect product safety, the FDA indicates that intentionally nanosizing already regulated food ingredients could require regulatory reevaluation.In other words, even though non-nanoscale hydroxyapatite is “Generally Regarded As Safe,” according to the FDA, the safety of any nanoscale form of the substance would need to be reevaluated before being added to food products.Despite this size-safety relationship, the FDA confirmed to me that the agency is unaware of any food substance intentionally engineered at the nanoscale that has enough generally available safety data to determine it should be “Generally Regarded As Safe.”Casting further uncertainty on the use of nanoscale hydroxyapatite in food, a 2015 report from the European Scientific Committee on Consumer Safety (SCCS) suggests there may be some cause for concern when it comes to this particular nanomaterial.Prompted by the use of nanoscale hydroxyapatite in dental products to strengthen teeth (which they consider “cosmetic products”), the SCCS reviewed published research on the material’s potential to cause harm. Their conclusion?

The available information indicates that nano-hydroxyapatite in needle-shaped form is of concern in relation to potential toxicity. Therefore, needle-shaped nano-hydroxyapatite should not be used in cosmetic products.

This recommendation was based on a handful of studies, none of which involved exposing people to the substance. Researchers injected hydroxyapatite needles directly into the bloodstream of rats. Others exposed cells outside the body to the material and observed the effects. In each case, there were tantalizing hints that the small particles interfered in some way with normal biological functions. But the results were insufficient to indicate whether the effects were meaningful in people.

As Andrew also notes in his essay, none of the studies examined by the SCCS OEuropean Scientific Committee on Consumer Safety) looked at what happens to nano-hydroxyapatite once it enters your gut and that is what the researchers at Arizona State University were considering (from the May 17, 2016 essay),

The good news is that, according to preliminary studies from ASU researchers, hydroxyapatite needles don’t last long in the digestive system.

This research is still being reviewed for publication. But early indications are that as soon as the needle-like nanoparticles hit the highly acidic fluid in the stomach, they begin to dissolve. So fast in fact, that by the time they leave the stomach – an exceedingly hostile environment – they are no longer the nanoparticles they started out as.

These findings make sense since we know hydroxyapatite dissolves in acids, and small particles typically dissolve faster than larger ones. So maybe nanoscale hydroxyapatite needles in food are safer than they sound.

This doesn’t mean that the nano-needles are completely off the hook, as some of them may get past the stomach intact and reach more vulnerable parts of the gut. But the findings do suggest these ultra-small needle-like particles could be an effective source of dietary calcium – possibly more so than larger or less needle-like particles that may not dissolve as quickly.

Intriguingly, recent research has indicated that calcium phosphate nanoparticles form naturally in our stomachs and go on to be an important part of our immune system. It’s possible that rapidly dissolving hydroxyapatite nano-needles are actually a boon, providing raw material for these natural and essential nanoparticles.

While it’s comforting to know that preliminary research suggests that the hydroxyapatite nanoparticles are likely safe for use in food products, Andrew points out that more needs to be done to insure safety (from the May 17, 2016 essay),

And yet, even if these needle-like hydroxyapatite nanoparticles in infant formula are ultimately a good thing, the FoE report raises a number of unresolved questions. Did the manufacturers knowingly add the nanoparticles to their products? How are they and the FDA ensuring the products’ safety? Do consumers have a right to know when they’re feeding their babies nanoparticles?

Whether the manufacturers knowingly added these particles to their formula is not clear. At this point, it’s not even clear why they might have been added, as hydroxyapatite does not appear to be a substantial source of calcium in most formula. …

And regardless of the benefits and risks of nanoparticles in infant formula, parents have a right to know what’s in the products they’re feeding their children. In Europe, food ingredients must be legally labeled if they are nanoscale. In the U.S., there is no such requirement, leaving American parents to feel somewhat left in the dark by producers, the FDA and policy makers.

As far as I’m aware, the Canadian situation is much the same as the US. If the material is considered safe at the macroscale, there is no requirement to indicate that a nanoscale version of the material is in the product.

I encourage you to read Andrew’s essay in its entirety. As for the FoE report (Nanoparticles in baby formula: Tiny new ingredients are a big concern), that is here.

AquAdvantage salmon (genetically modified) approved for consumption in Canada

This is an update of the AquAdvantage salmon story covered in my Dec. 4, 2015 post (scroll down about 40% of the way). At the time, the US Food and Drug Administration (FDA) had just given approval for consumption of the fish. There was speculation there would be a long hard fight over approval in Canada. This does not seem to have been the case, according to a May 10, 2016 news item announcing Health Canada’s on phys.org,

Canada’s health ministry on Thursday [May 19, 2016] approved a type of genetically modified salmon as safe to eat, making it the first transgenic animal destined for Canadian dinner tables.

This comes six months after US authorities gave the green light to sell the fish in American grocery stores.

The decisions by Health Canada and the US Food and Drug Administration follow two decades of controversy over the fish, which is an Atlantic salmon injected with genes from Pacific Chinook salmon and a fish known as the ocean pout to make it grow faster.

The resulting fish, called AquAdvantage Salmon, is made by AquaBounty Technologies in Massachusetts, and can reach adult size in 16 to 18 months instead of 30 months for normal Atlantic salmon.

A May 19, 2016 BIOTECanada news release on businesswire provides more detail about one of the salmon’s Canadian connections,

Canadian technology emanating from Memorial University developed the AquAdvantage salmon by introducing a growth hormone gene from Chinook salmon into the genome of Atlantic salmon. This results in a salmon which grows faster and reaches market size quicker and AquAdvantage salmon is identical to other farmed salmon. The AquAdvantage salmon also received US FDA approval in November 2015. With the growing world population, AquaBounty is one of many biotechnology companies offering safe and sustainable means to enhance the security and supply of food in the world. AquaBounty has improved the productivity of aquaculture through its use of biotechnology and modern breeding technics that have led to the development of AquAdvantage salmon.

“Importantly, today’s approval is a result of a four year science-based regulatory approval process which involved four federal government departments including Agriculture and AgriFood, Canada Food Inspection Agency, Environment and Climate Change, Fisheries and Oceans and Health which demonstrates the rigour and scope of science based regulatory approvals in Canada. Coupled with the report from the [US] National Academy of Sciences today’s [May 19, 2016] approval clearly demonstrates that genetic engineering of food is not only necessary but also extremely safe,” concluded Casey [Andrew Casey, President and CEO BIOTECanada].

There’s another connection, the salmon hatcheries are based in Prince Edward Island.

While BIOTECanada’s Andrew Casey is crowing about this approval, it should be noted that there was a losing court battle with British Columbia’s Living Oceans Society and Nova Scotia’s Ecology Action Centre both challenging the federal government’s approval. They may have lost battle but, as the cliché goes, ‘the war is not over yet’. There’s an Issue about the lack of labeling and there’s always the  possibility that retailers and/or consumers may decide to boycott the fish.

As for BIOTECanada, there’s this description from the news release,

BIOTECanada is the national industry association with more than 230 members reflecting the diverse nature of Canada’s health, industrial and agricultural biotechnology sectors. In addition to providing significant health benefits for Canadians, the biotechnology industry has quickly become an essential part of the transformation of many traditional cornerstones of the Canadian economy including manufacturing, automotive, energy, aerospace and forestry industries. Biotechnology in all of its applications from health, agriculture and industrial is offering solutions for the collective population.

You can find the BIOTECanada website here.

Personally, I’m a bit ambivalent about it all. I understand the necessity for changing our food production processes but I do think more attention should be paid to consumers’ concerns and that organizations such as BIOTECanada could do a better job of communicating.

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.

January 31, 2016 deadlines for early bird tickets (ESOF) and conference abstracts (emerging technologies)

ESOF 2016 (EuroScience Open Forum)

Early bird tickets for this biennial science conference are available until Jan.  31, 2016 according to a Jan. 18, 2016 email notice,

Our most affordable tickets are available to purchase until the end of the month, so make sure you get yours before they disappear. Prices start from only £75 for a full four-day pass for early careers researchers (up to 5 years post doc), and £225 for a full delegate pass. All registrations are entitled to a year long complimentary subscription to Nature at this time.

You can also book your accommodation when you register to attend ESOF. We have worked hard with our city partners to bring you the best deals for your stay in Manchester. With the summer set to be busy with not only ESOF but major international sporting events, make sure you take advantage of these deals.

To register to attend please click here

You can find out more about the event which takes place from July 23 – 27, 2016 in Manchester, England here and/or you can watch this video,

For any interested journalists, media registration has opened (from the Jan. 18, 2016 notice),

Media registration opens

We are delighted to announce our ESOF press accreditation is available for journalists and science communications professionals to register for the conference. Accreditation provides complimentary access to the full ESOF programme, social events and a range of exclusive press only activities. Further details of the eligibility criteria and registration process can be found here.

Nature Publishing Group offers journalists a travel grant which will cover most if not all the expenses associated with attending 2016 ESOF (from the ESOF Nature Travel Grant webpage),

The Nature Travel Grant Scheme offers journalists and members of media organisations from around the world the opportunity to attend ESOF for free. The grant offers complimentary registration as well as help covering travel and accommodation costs.

1. Purpose

Created by EuroScience, the biennial ESOF – EuroScience Open Forum – meeting is the largest pan-European general science conference dedicated to scientific research and innovation. At ESOF meetings leading scientists, researchers, journalists, business people, policy makers and the general public from all over the world discuss new discoveries and debate the direction that research is taking in the sciences, humanities and social sciences.

Springer Nature is a leading global research, educational and professional publisher, home to an array of respected and trusted brands providing quality content through a range of innovative products and services, including the journal Nature. Springer Nature was formed in 2015 through the merger of Nature Publishing Group, Palgrave Macmillan, Macmillan Education and Springer Science+Business Media. Nature Publishing Group has supported ESOF since its very first meeting in 2004.

Similar to the 2012 and 2014 edition of meeting, Springer Nature is funding the Nature Travel Grant Scheme for journalists to attend ESOF2016 with the aim to increase the impact of ESOF.

2. The Scheme

In addition to free registration, the Nature Travel Grant Scheme offers a lump sum of £450 for UK based journalists, £600 for journalists based in Europe and £800 for journalists based outside of Europe, to help cover the costs of travel and accommodation to attend ESOF2016.

3. Who can apply?

All journalists irrespective of their gender, age, nationality, place of residence and media type (paper, radio, TV, web) are welcome to apply. Media accreditation will be required.

4. Application procedure

To submit an application sign into the EuroScience Conference and Membership Platform (ESCMP) and click on “Apply for a Grant”. Follow the application procedure.

On submitting the application form for travel grants, you agree to the full acceptance of the rules and to the decision taken by the Selection Committee.

The deadline for submitting an application is February 29th 2016, 12:00 pm CET.

Good luck!

4th Annual Governance of Emerging Technologies: Law, Policy and Ethics Conference

Here’s more about the conference (deadline for abstracts is Jan. 31, 2016) from the conference’s Call for Abstract’s webpage,

Fourth Annual Conference on
Governance of Emerging Technologies: Law, Policy, and Ethics

May 24-26, 2016, Tempe, Arizona

Call for abstracts:

The co-sponsors invite submission of abstracts for proposed presentations.  Submitters of abstracts need not provide a written paper, although provision will be made for posting and possible post-conference publication of papers for those presenters interested in such options.  Although abstracts are invited for any aspect or topic relating to the governance of emerging technologies, some particular themes that will be emphasized at this year’s conference include existential or catastrophic risks, governance implications of algorithms, resilience and emerging technologies, artificial intelligence, military technologies, and gene editing.

Abstracts should not exceed 500 words.
Abstracts must be submitted by January 31, 2016 to be considered.
Decisions on abstracts will be made by the program committee and communicated by February 29 [2016]. 

Funding: The sponsors will pay for the conference registration (including all conference meals) for one presenter for each accepted abstract.  In addition, we will have limited funds available for travel subsidies in whole or in part.  After completing your abstract online, you will be asked if you wish to apply for a travel subsidy.  Any such additional funding will be awarded based on the strength of the abstract, demonstration of financial need, and/or the potential to encourage student authors and early-career scholars.  Accepted presenters for whom conference funding is not available will need to pay their own transportation and hotel costs.

For more information, please contact Lauren Burkhart at Lauren.Burkhart@asu.edu.

You don’t often see conference organizers offering to pay registration and meals for a single presenter from each accepted submission. Good luck!

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.

A couple of lawyers talk wrote about managing nanotechnology risks

Because they are lawyers, I was intrigued by a Nov. 4, 2015 article on managing nanotechnology risks by Michael Lisak and James Mizgala of Sidley Austin LLP for Industry Week. I was also intrigued by the language (Note: A link has been removed),

The inclusion of nanotechnologies within manufacturing processes and products has increased exponentially over the past decade. Fortune recently noted that nanotechnology touches almost all Fortune 500 companies and that the industry’s $20 billion worldwide size is expected to double over the next decade. [emphasis mine]

Yet, potential safety issues have been raised and regulatory uncertainties persist. As such, proactive manufacturers seeking to protect their employees, consumers, the environment and their businesses – while continuing to develop, manufacture and market their products – may face difficult choices in how to best navigate this challenging and fluid landscape, while avoiding potential “nanotort,”  [emphasis mine] whistleblower, consumer fraud and regulatory enforcement lawsuits. Doing so requires forward-thinking advice based upon detailed analyses of each manufacturer’s products and conduct in the context of rapidly evolving scientific, regulatory and legal developments.

I wonder how many terms lawyers are going to coin in addition to “nanotort”?

The lawyers focus largely on two types of nanoparticles, carbon nanotubes, with a special emphasis on multi-walled carbon nantubes (MWCNT) and nano titanium dioxide,

Despite this scientific uncertainty, international organizations, such as the International Agency for Research on Cancer [a World Health Organization agency], have already concluded that nano titanium dioxide in its powder form and multi-walled carbon nanotube-7 (“MWCNT-7”) [emphasis mine] are “possibly carcinogenic to humans.” As such, California’s Department of Public Health lists titanium dioxide and MWCNT-7 as “ingredients known or suspected to cause cancer, birth defects, or other reproductive toxicity as determined by the authoritative scientific bodies.”  Considering that processed (i.e., non-powdered) titanium dioxide is found in products like toothpaste, shampoo, chewing gum and candies, it is not surprising that some have focused upon such statements.

There’s a lot of poison in the world, for example, apples contain seeds which have arsenic in them and, for another, peanuts can be carcinogenic and they can also kill you, as they are poison to people who are allergic to them.

On the occasion of Dunkin’ Donuts removing nano titanium dioxide as an ingredient in the powdered sugar used to coat donuts, I wrote a March 13, 2015 posting, where I quote extensively from Dr. Andrew Maynard’s (then director of the University of Michigan Risk Science Center now director of the Risk Innovation Lab at Arizona State University) 2020 science blog posting about nano titanium dioxide and Dunkin’ Donuts,

He describes some of the research on nano titanium dioxide (Note: Links have been removed),

… In 2004 the European Food Safety Agency carried out a comprehensive safety review of the material. After considering the available evidence on the same materials that are currently being used in products like Dunkin’ Donuts, the review panel concluded that there no evidence for safety concerns.

Most research on titanium dioxide nanoparticles has been carried out on ones that are inhaled, not ones we eat. Yet nanoparticles in the gut are a very different proposition to those that are breathed in.

Studies into the impacts of ingested nanoparticles are still in their infancy, and more research is definitely needed. Early indications are that the gastrointestinal tract is pretty good at handling small quantities of these fine particles. This stands to reason given the naturally occurring nanoparticles we inadvertently eat every day, from charred foods and soil residue on veggies and salad, to more esoteric products such as clay-baked potatoes. There’s even evidence that nanoparticles occur naturally inside the gastrointestinal tract.

You can find Andrew’s entire discussion in his March 12, 2015 post on the 2020 Science blog. Andrew had written earlier in a July 12, 2014 posting about something he terms ‘nano donut math’ as reported by As You Sow, the activist group that made a Dunkin’ Donuts shareholder proposal which resulted in the company’s decision to stop using nano titanium dioxide in the powdered sugar found on their donuts. In any event, Andrew made this point,

In other words, if a Dunkin’ Donut Powdered Cake Donut contained 8.9 mg of TiO2 particles smaller than 10 nm, it would have to have been doused with over 1 million tons of sugar coating! (Note update at the end of this piece)

Clearly something’s wrong here – either Dunkin’ Donuts are not using food grade TiO2 but a nanopowder with particle so small they would be no use whatsoever in the sugar coating (as well as being incredibly expensive, and not FDA approved).  Or there’s something rather wrong with the analysis!

If it’s the latter – and it’s hard to imagine any other plausible reason for the data – it looks like As You Sow ended up using rather dubious figures to back up their stakeholder resolution.  I’d certainly be interested in more information on the procedures Analytical Sciences used and the checks and balances they had in place, especially as there are a number of things that can mess up a particle analysis like this.

Update July 14: My bad, I made a slight error in the size distribution calculation first time round.  This has been corrected in the article above.  Originally, I cited the estimated Mass Median Diameter (MMD) of the TiO2 particles as 167 nm, and the Geometric Standard Deviation (GSD) as 1.6.  Correcting an error in the Excel spreadsheet used to calculate the distribution (these things happen!) led to a revised estimate of MMD = 168 nm and a GSD of 1.44.  These may look like subtle differences, but when calculating the estimated particle mass below 10 nm, they make a massive difference.  With the revised figures, you’d expect less than one trillionth of  a percent of the mass of the TiO2 powder to be below 10 nm!! (the original estimate was a tenth of a millionth of a percent).  In other words – pretty much nothing!  The full analysis can be found here.

Update November 16 2014.  Based on this post, As You Sow checked the data from Analytical Sciences LLC and revised the report accordingly.  This is noted above.

It would seem that if there are concerns over nano titanium dioxide in food, the biggest would not be the amounts ingested by consumers but inhalation by workers should they breathe in large quantities when they are handling the material.

As for the MWCNTs, they have long raised alarms but most especially the long MWCNTs and for people handling them during the course of their work day. Any MWCNTs found in sports equipment and other consumer products are bound in the material and don’t pose any danger of being inhaled into the lungs, unless they should be released from their bound state (e.g. fire might release them).

After some searching for MWCNT-7, I found something which seems also to be known as Mitsui MWCNT-7 or Mitsui 7-MWCNT (here’s one of my sources). As best I understand it, Mitsui is a company that produces an MWCNT which they have coined an MWCNT-7 and which has been used in nanotoxicity testing. As best I can tell, MWCNT is MWCNT-7.

The lawyers (Lisak and Mizgala) note things have changed for manufacturers since the early days and they make some suggestions,

One thing is certain – gone are the days when “sophisticated” manufacturers incorporating nanotechnologies within their products can reasonably expect to shield themselves by pointing to scientific and regulatory uncertainties, especially given the amount of money they are spending on research and development, as well as sales and marketing efforts.

Accordingly, manufacturers should consider undertaking meaningful risk management analyses specific to their applicable products. …

First, manufacturers should fully understand the life-cycle of nanomaterials within their organization. For some, nanomaterials may be an explicit focus of innovation and production, making it easier to pinpoint where nanotechnology fits into their processes and products. For others, nanomaterials may exist either higher-up or in the back-end of their products’ supply chain. …

Second, manufacturers should understand and stay current with the scientific state-of-the-art as well as regulatory requirements and developments potentially applicable to their employees, consumers and the environment. An important consideration related to efforts to understand the state-of-the-art is whether or not manufacturers should themselves expend resources to advance “the science” in seeking to help find answers to some of the aforementioned uncertainties. …

The lawyers go on to suggest that manufacturers should consider proactively researching nanotoxicity so as to better defend themselves against any future legal suits.

Encouraging companies to proactive with toxicity issues is in line with what seems to be an international (Europe & US) regulatory movement putting more onus on producers and manufacturers to take responsibility for safety testing. (This was communicated to me in a conversation I had with an official at the European Union Joint Research Centre where he mentioned REACH regulations and the new emphasis in response to my mention of similar FDA (US Food and Drug Administration) regulations. (We were at the 2014 9th World Congress on Alternatives to Animal Testing in Prague, Czech republic.)

For anyone interested in the International Agency for Research on Cancer you can find it here.