Category Archives: risk

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.

Nano and food discussion for beginners

I try to make sure there are a range of posts here for various levels of ‘nanotechnology sophistication’ but over time I’ve given less attention to ‘beginner’ posts, i.e., pieces where nanotechnology basics are explained as best as possible. This is largely due to concerns about repetition; I mean, how many times do you want to read that nano means one billionth?

In that spirit, this June 22, 2016 news item on Nanowerk about food and nanotechnology provides a good entry piece that is not terribly repetitive,

Every mouthful of food we eat is teeming with chemical reactions. Adding ingredients and cooking helps us control these reactions and makes the food taste better and last longer. So what if we could target food at the molecular level, sending in specially designed particles to control reactions even more tightly? Well, this is exactly what scientists are trying to do and it has already produced some impressive results – from food that tastes salty without the health risks of adding salt, to bread that contains healthy fish oil but without any fishy aftertaste.

But while this nanotechnology could significantly enhance our food, it also raises big questions about safety. We only have to look at the strong reaction against genetically modified foods to see how important this issue is. How can we ensure that nanotechnology in food will be different? Will our food be safe? And will people accept these new foods?

Nanotechnology is an emerging technology that creates and uses materials and particles at the scale of a nanometre, one billionth of a metre. To get an understanding of just how small this is, if you imagine a nanoparticle was the size of a football then an animal like a sheep would be as big as our planet.

Working with such small particles allows us to create materials and products with improved properties, from lighter bicycles and more durable beer bottles to cosmetic creams with better absorption and toothpastes that stop bacteria from growing. Being able to change a material’s properties means nanotechnology can help create many innovative food products and applications that change the way we process, preserve and package foods.

For example, nanotechnology can be used for “smart” packaging that can monitor the condition of foods while they are stored and transported. When foods are contaminated or going off, the sensors on the packaging pick up gases produced by bacteria and change colour to alert anyone who wants to eat the food.

A June 22, 2016 essay by Seda Erdem (University of Stirling; UK) on The Conversation, which originated the news item, provides more information in this excerpt,

Silver is already used in healthcare products such as dental equipment for its antibacterial properties. Nano-sizing silver particles improves their ability to kill bacteria because it increases the surface area of silver the bacteria are exposed to. Israeli scientists found that also coating packaging paper with nano-sized silver particles [also known as silver nanoparticles] combats bacteria such as E. coli and extends product shelf life.

Another example of nanotechnology’s use in food manufacturing is nano-encapsulation. This technology has been used to mask the taste and odour of tuna fish oil so that it could be used to enrich bread with heart healthy Omega-3 fatty acids. Fish oil particles are packed into a film coating that prevents the fish oil from reacting with oxygen and releasing its smell. The nanocapsules break open only when they reach the stomach so you can receive the health benefits of eating them without experiencing the odour.

Meanwhile, researchers at Nottingham University are looking into nanoscale salt particles than can increase the saltiness of food without increasing the amount of salt.

As with silver, breaking salt into smaller nanosize increases its surface area. This means its flavour can be spread more efficiently. The researchers claim this can reduce the salt content of standard crisps by 90% while keeping the same flavour.

Despite all the opportunities nanotechnology offers the food industry, most developments remain at the research and development stage. This slow uptake is due to the lack of information about the health and environmental impacts of the technology. For example, there is a concern whether ingested nanomaterials migrate to different parts of the body and accumulate in certain organs, such as liver and kidneys. This may then affect the functionality of these organs in the medium to long term.

Unknown risks

However, our knowledge of the risks associated with the use of nanomaterials is incomplete. These issues need to be better understood and addressed for the public to accept nanotechnology in food. This will also depend on the public’s understanding of the technology and how much they trust the food industry and the regulatory process watching over it.

Research has shown, for example, that consumers are more likely to accept nanotechnology when it is used in food packaging rather than in food processing. But nanotechnology in food production was seen as more acceptable if it increased the food’s health benefits, although consumers weren’t necessarily willing to pay more for this.

In our recent research, we found no strong attitudes towards or resistance to nanotechnology in food packaging in the UK. But there was still concern among a small group of consumers about the safety of foods. This shows how important it will be for food producers and regulators to provide consumers with the best available information about nanotechnology, including any uncertainties about the technology.

There you have it.

nanoIndEx publishes guidance document on assessing exposure to airborne nanomaterials

Lynn Bergeson’s June 21, 2016 posting on Nanotechnology Now announced a newly published guidance document from the European Union’s nanoIndEx,

… The guidance document summarizes the key findings of the project, and is intended to present the state of the art in personal exposure assessment for nanomaterials. The conclusions section states: “Unfortunately, many nanotoxicological studies have used excessive, unrealistically high doses of [manufactured nanomaterials] and it is therefore debatable what their findings mean for the lower real-world exposures of humans. Moreover, it is not clear how to establish realistic exposure dose testing in toxicological studies, as available data on occupational exposure levels are still sparse.” According to the guidance document, future studies should focus on the potentially adverse effects of low-level and realistic exposure to manufactured nanomaterials, especially through the use of exposure doses similar to those identified in environmental sampling.

You can find the 49pp PDF here or here. To whet your appetite, here’s a bit from the introduction to the “Exposure to Airborne Nanomaterials; A Guidance Document,”

… While human exposure to MNMs may in principle occur during any stage of the material’s lifecycle, it is most likely in workplaces, where these materials are produced or handled in large quantities or over long periods of time. Inhalation is considered as the most critical uptake route, because the small particles are able to penetrate deep into the lung and deposit in the gas exchange region. Inhalation exposure to airborne nanomaterials therefore needs to be assessed in view of worker protection.

Exposure to airborne particles can generally best be assessed by measuring the individual exposure in the personal breathing zone (PBZ) of an individual. The PBZ is defined as a 30 cm hemisphere around mouth and nose [2]. Measurements in the PBZ require instruments that are small and light-weight. The individual exposure specifically to MNMs [manufactured nanomaterials, sometimes also known as engineered nanomaterials or nanoparticles] has not been assessable in the past due to the lack of suitable personal samplers and/or monitors. Instead, most studies related to exposure to MNMs have been carried out using either bulky static measurement equipment or not nanospecific personal samplers. In recent years, novel samplers and monitors have been introduced that allow for an assessment of the more nanospecific personal exposure to airborne MNMs. In the terminology used in nanoIndEx, samplers are devices that collect particles on a substrate, e.g. a filter
of flat surface, for subsequent analysis, whereas monitors are real-time instruments that deliver
information on the airborne concentrations with high time resolution. Scientifically sound investigations on the accuracy, comparability and field applicability of these novel samplers and monitors had been lacking. … (p. 4 print; p. 6 PDF)

There’s also a brief description of the nanoindEX project in the Introduction,

The three-year project started on June 1st, 2013, and has been funded under the frame of SIINN, the ERA-NET [European Research Area Network] for a Safe Implementation of Innovative Nanoscience and Nanotechnology [SINN]. The aim of the project was to scrutinise the instrumentation available for personal exposure assessment concerning their field readiness and usability in order to use this information to generate reliable data on personal exposure in real workplaces and to eventually widely distribute the findings among the interested public. This Guidance Document you are holding in your hands summarises the key findings of the project. (p. 5 print; p. 7 PDF)

As I understand it, the area of most concern where nanotoxicology is concerned would be inhalation of nanoparticles into the lungs as the body has fewer protections in the respiratory tract than it has elsewhere, e.g. skin or digestive system.

Lungs: EU SmartNanoTox and Pneumo NP

I have three news bits about lungs one concerning relatively new techniques for testing the impact nanomaterials may have on lungs and two concerning developments at PneumoNP; the first regarding a new technique for getting antibiotics to a lung infected with pneumonia and the second, a new antibiotic.

Predicting nanotoxicity in the lungs

From a June 13, 2016 news item on Nanowerk,

Scientists at the Helmholtz Zentrum München [German Research Centre for Environmental Health] have received more than one million euros in the framework of the European Horizon 2020 Initiative [a major European Commission science funding initiative successor to the Framework Programme 7 initiative]. Dr. Tobias Stöger and Dr. Otmar Schmid from the Institute of Lung Biology and Disease and the Comprehensive Pneumology Center (CPC) will be using the funds to develop new tests to assess risks posed by nanomaterials in the airways. This could contribute to reducing the need for complex toxicity tests.

A June 13, 2016 Helmholtz Zentrum München (German Research Centre for Environmental Health) press release, which originated the news item, expands on the theme,

Nanoparticles are extremely small particles that can penetrate into remote parts of the body. While researchers are investigating various strategies for harvesting the potential of nanoparticles for medical applications, they could also pose inherent health risks*. Currently the hazard assessment of nanomaterials necessitates a complex and laborious procedure. In addition to complete material characterization, controlled exposure studies are needed for each nanomaterial in order to guarantee the toxicological safety.

As a part of the EU SmartNanoTox project, which has now been funded with a total of eight million euros, eleven European research partners, including the Helmholtz Zentrum München, want to develop a new concept for the toxicological assessment of nanomaterials.

Reference database for hazardous substances

Biologist Tobias Stöger and physicist Otmar Schmid, both research group heads at the Institute of Lung Biology and Disease, hope that the use of modern methods will help to advance the assessment procedure. “We hope to make more reliable nanotoxicity predictions by using modern approaches involving systems biology, computer modelling, and appropriate statistical methods,” states Stöger.

The lung experts are concentrating primarily on the respiratory tract. The approach involves defining a representative selection of toxic nanomaterials and conducting an in-depth examination of their structure and the various molecular modes of action that lead to their toxicity. These data are then digitalized and transferred to a reference database for new nanomaterials. Economical tests that are easy to conduct should then make it possible to assess the toxicological potential of these new nanomaterials by comparing the test results s with what is already known from the database. “This should make it possible to predict whether or not a newly developed nanomaterial poses a health risk,” Otmar Schmid says.

* Review: Schmid, O. and Stoeger, T. (2016). Surface area is the biologically most effective dose metric for acute nanoparticle toxicity in the lung. Journal of Aerosol Science, DOI:10.1016/j.jaerosci.2015.12.006

The SmartNanoTox webpage is here on the European Commission’s Cordis website.

Carrying antibiotics into lungs (PneumoNP)

I received this news from the European Commission’s PneumoNP project (I wrote about PneumoNP in a June 26, 2014 posting when it was first announced). This latest development is from a March 21, 2016 email (the original can be found here on the How to pack antibiotics in nanocarriers webpage on the PneumoNP website),

PneumoNP researchers work on a complex task: attach or encapsulate antibiotics with nanocarriers that are stable enough to be included in an aerosol formulation, to pass through respiratory tracts and finally deliver antibiotics on areas of lungs affected by pneumonia infections. The good news is that they finally identify two promising methods to generate nanocarriers.

So far, compacting polymer coils into single-chain nanoparticles in water and mild conditions was an unsolved issue. But in Spain, IK4-CIDETEC scientists developed a covalent-based method that produces nanocarriers with remarkable stability under those particular conditions. Cherry on the cake, the preparation is scalable for more industrial production. IK4-CIDETEC patented the process.

Fig.: A polymer coil (step 1) compacts into a nanocarrier with cross-linkers (step 2). Then, antibiotics get attached to the nanocarrier (step 3).

Fig.: A polymer coil (step 1) compacts into a nanocarrier with cross-linkers (step 2). Then, antibiotics get attached to the nanocarrier (step 3).

At the same time, another route to produce lipidic nanocarriers have been developed by researchers from Utrecht University. In particular, they optimized the method consisting in assembling lipids directly around a drug. As a result, generated lipidic nanocarriers show encouraging stability properties and are able to carry sufficient quantity of antibiotics.

Fig.: On presence of antibiotics, the lipidic layer (step 1) aggregates the the drug (step 2) until the lipids forms a capsule around the antibiotics (step 3).

Fig.: On presence of antibiotics, a lipidic layer (step 1) aggregates the drug (step 2) until the lipids forms a capsule around antibiotics (step 3).

Assays of both polymeric and lipidic nanocarriers are currently performed by ITEM Fraunhofer Institute in Germany, Ingeniatrics Tecnologias in Spain and Erasmus Medical Centre in the Netherlands. Part of these tests allows to make sure that the nanocarriers are not toxic to cells. Other tests are also done to verify that the efficiency of antibiotics on Klebsiella Pneumoniae bacteria when they are attached to nanocarriers.

A new antibiotic for pneumonia (PneumoNP)

A June 14, 2016 PneumoNP press release (received via email) announces work on a promising new approach to an antibiotic for pneumonia,

The antimicrobial peptide M33 may be the long-sought substitute to treat difficult lung infections, like multi-drug resistant pneumonia.

In 2013, the European Respiratory Society predicted 3 millions cases of pneumonia in Europe every year [1]. The standard treatment for pneumonia is an intravenous administration of a combination of drugs. This leads to the development of antibiotic resistance in the population. Gradually, doctors are running out of solutions to cure patients. An Italian company suggests a new option: the M33 peptide.

Few years ago, the Italian company SetLance SRL decided to investigate the M33 peptide. The antimicrobial peptide is an optimized version of an artificial peptide sequence selected for its efficacy and stability. So far, it showed encouraging in-vitro results against multidrug-resistant Gram-negative bacteria, including Klebsiella Pneumoniae. With the support of EU funding to the PneumoNP project, SetLance SRL had the opportunity to develop a new formulation of M33 that enhances its antimicrobial activity.

The new formulation of M33 fights Gram-negative bacteria in three steps. First of all, the M33 binds with the lipopolysaccharides (LPS) on the outer membrane of bacteria. Then, the molecule forms a helix and finally disrupts the membrane provoking cytoplasm leaking. The peptide enabled up to 80% of mices to survive Pseudomonas Aeruginosa-based lung infections. Beyond these encouraging results, toxicity to the new M33 formulation seems to be much lower than antimicrobial peptides currently used in clinical practice like colistin [2].

Lately, SetLance scaled-up the synthesis route and is now able to produce several hundred milligrams per batch. The molecule is robust enough for industrial production. We may expect this drug to go on clinical development and validation at the beginning of 2018.

[1] http://www.erswhitebook.org/chapters/acute-lower-respiratory-infections/pneumonia/
[2] Ceccherini et al., Antimicrobial activity of levofloxacin-M33 peptide conjugation or combination, Chem Med Comm. 2016; Brunetti et al., In vitro and in vivo efficacy, toxicity, bio-distribution and resistance selection of a novel antibacterial drug candidate. Scientific Reports 2016

I believe all the references are open access.

Brief final comment

The only element linking these news bits together is that they concern the lungs.

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.

June 2016: time for a post on nanosunscreens—risks and perceptions

In the years since this blog began (2006), there’ve been pretty regular postings about nanosunscreens. While there are always concerns about nanoparticles and health, there has been no evidence to support a ban (personal or governmental) on nanosunscreens. A June 2016 report  by Paul FA Wright (full reference information to follow) in an Australian medical journal provides the latest insights on safety and nanosunscreens. Wright first offers a general introduction to risks and nanomaterials (Note: Links have been removed),

In reality, a one-size-fits-all approach to evaluating the potential risks and benefits of nanotechnology for human health is not possible because it is both impractical and would be misguided. There are many types of engineered nanomaterials, and not all are alike or potential hazards. Many factors should be considered when evaluating the potential risks associated with an engineered nanomaterial: the likelihood of being exposed to nanoparticles (ranging in size from 1 to 100 nanometres, about one-thousandth of the width of a human hair) that may be shed by the nanomaterial; whether there are any hotspots of potential exposure to shed nanoparticles over the whole of the nanomaterial’s life cycle; identifying who or what may be exposed; the eventual fate of the shed nanoparticles; and whether there is a likelihood of adverse biological effects arising from these exposure scenarios.1

The intrinsic toxic properties of compounds contained in the nanoparticle are also important, as well as particle size, shape, surface charge and physico-chemical characteristics, as these greatly influence their uptake by cells and the potential for subsequent biological effects. In summary, nanoparticles are more likely to have higher toxicity than bulk material if they are insoluble, penetrate biological membranes, persist in the body, or (where exposure is by inhalation) are long and fibre-like.1 Ideally, nanomaterial development should incorporate a safety-by-design approach, as there is a marketing edge for nano-enabled products with a reduced potential impact on health and the environment.1

Wright also covers some of nanotechnology’s hoped for benefits but it’s the nanosunscreen which is the main focus of this paper (Note: Links have been removed),

Public perception of the potential risks posed by nanotechnology is very different in certain regions. In Asia, where there is a very positive perception of nanotechnology, some products have been marketed as being nano-enabled to justify charging a premium price. This has resulted in at least four Asian economies adopting state-operated, user-financed product testing schemes to verify nano-related marketing claims, such as the original “nanoMark” certification system in Taiwan.4

In contrast, the negative perception of nanotechnology in some other regions may result in questionable marketing decisions; for example, reducing the levels of zinc oxide nanoparticles included as the active ingredient in sunscreens. This is despite their use in sunscreens having been extensively and repeatedly assessed for safety by regulatory authorities around the world, leading to their being widely accepted as safe to use in sunscreens and lip products.5

Wright goes on to describe the situation in Australia (Note: Links have been removed),

Weighing the potential risks and benefits of using sunscreens with UV-filtering nanoparticles is an important issue for public health in Australia, which has the highest rate of skin cancer in the world as the result of excessive UV exposure. Some consumers are concerned about using these nano-sunscreens,6 despite their many advantages over conventional organic chemical UV filters, which can cause skin irritation and allergies, need to be re-applied more frequently, and are absorbed by the skin to a much greater extent (including some with potentially endocrine-disrupting activity). Zinc oxide nanoparticles are highly suitable for use in sunscreens as a physical broad spectrum UV filter because of their UV stability, non-irritating nature, hypo-allergenicity and visible transparency, while also having a greater UV-attenuating capacity than bulk material (particles larger than 100 nm in diameter) on a per weight basis.7

Concerns about nano-sunscreens began in 2008 with a report that nanoparticles in some could bleach the painted surfaces of coated steel.8 This is a completely different exposure situation to the actual use of nano-sunscreen by people; here they are formulated to remain on the skin’s surface, which is constantly shedding its outer layer of dead cells (the stratum corneum). Many studies have shown that metal oxide nanoparticles do not readily penetrate the stratum corneum of human skin, including a hallmark Australian investigation by Gulson and co-workers of sunscreens containing only a less abundant stable isotope of zinc that allowed precise tracking of the fate of sunscreen zinc.9 The researchers found that there was little difference between nanoparticle and bulk zinc oxide sunscreens in the amount of zinc absorbed into the body after repeated skin application during beach trials. The amount absorbed was also extremely small when compared with the normal levels of zinc required as an essential mineral for human nutrition, and the rate of skin absorption was much lower than that of the more commonly used chemical UV filters.9 Animal studies generally find much higher skin absorption of zinc from dermal application of zinc oxide sunscreens than do human studies, including the meticulous studies in hairless mice conducted by the Commonwealth Scientific and Industrial Research Organisation (CSIRO) using both nanoparticle and bulk zinc oxide sunscreens that contained the less abundant stable zinc isotope.10 These researchers reported that the zinc absorbed from sunscreen was distributed throughout several major organs, but it did not alter their total zinc concentrations, and that overall zinc homeostasis was maintained.10

He then discusses titanium dioxide nanoparticles (also used in nanosunscreens, Note: Links have been removed),

The other metal oxide UV filter is titanium dioxide. Two distinct crystalline forms have been used: the photo-active anatase form and the much less photo-active rutile form,7 which is preferable for sunscreen formulations. While these insoluble nanoparticles may penetrate deeper into the stratum corneum than zinc oxide, they are also widely accepted as being safe to use in non-sprayable sunscreens.11

Investigation of their direct effects on human skin and immune cells have shown that sunscreen nanoparticles of zinc oxide and rutile titanium dioxide are as well tolerated as zinc ions and conventional organic chemical UV filters in human cell test systems.12 Synchrotron X-ray fluorescence imaging has also shown that human immune cells break down zinc oxide nanoparticles similar to those in nano-sunscreens, indicating that immune cells can handle such particles.13 Cytotoxicity occurred only at very high concentrations of zinc oxide nanoparticles, after cellular uptake and intracellular dissolution,14 and further modification of the nanoparticle surface can be used to reduce both uptake by cells and consequent cytotoxicity.15

The ongoing debate about the safety of nanoparticles in sunscreens raised concerns that they may potentially increase free radical levels in human skin during co-exposure to UV light.6 On the contrary, we have seen that zinc oxide and rutile titanium dioxide nanoparticles directly reduce the quantity of damaging free radicals in human immune cells in vitro when they are co-exposed to the more penetrating UV-A wavelengths of sunlight.16 We also identified zinc-containing nanoparticles that form immediately when dissolved zinc ions are added to cell culture media and pure serum, which suggests that they may even play a role in natural zinc transport.17

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

Potential risks and benefits of nanotechnology: perceptions of risk in sunscreens by Paul FA Wright. Med J Aust 2016; 204 (10): 369-370. doi:10.5694/mja15.01128 Published June 6, 2016

This paper appears to be open access.

The situation regarding perceptions of nanosunscreens in Australia was rather unfortunate as I noted in my Feb. 9, 2012 posting about a then recent government study which showed that some Australians were avoiding all sunscreens due to fears about nanoparticles. Since then Friends of the Earth seems to have moderated its stance on nanosunscreens but there is a July 20, 2010 posting (includes links to a back-and-forth exchange between Dr. Andrew Maynard and Friends of the Earth representatives) which provides insight into the ‘debate’ prior to the 2012 ‘debacle’. For a briefer overview of the situation you could check out my Oct. 4, 2012 posting.

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.

UK and US issue documents nanomaterial safety to support safe work with nanomaterials

I am featuring two bits of information about nanosafety first from the UK and then from the US.

UK and nanosafety

A May 30, 2016 news item on Nanowerk announces a not particularly exciting but necessary report on handling nanomaterials safely (Note: A link has been removed),

The UK Nanosafety Group (UKNSG) has updated and published a 2nd edition of guidance (pdf) to support safe and responsible working practices with nanomaterials in research and development laboratories.

A May 25, 2016 UK Nanosafety Group press release, which originated the news item, provides more detail,

The document aims to provide guidance on factors relating to establishing a safe workplace and good safety practice when working with particulate nanomaterials. It is applicable to a wide range of nanomaterials, including particles, fibres, powders, tubes and wires as well as aggregates and agglomerates, and recognises previous and current uncertainty in developing effective risk management when dealing with nanomaterials and advocates a precautionary strategy to minimise potential exposure.

The 2nd edition of the guidance provides updates to account for changes in legislation, recent studies in the literature, and best practice since 2012. In particular, specific sections have been revised to account for the full implementation of Global Harmonised System (GHS) which came into force on 1 June 2015 through the CLP [Classification, Labelling and Packaging] regulations. The document explains the approaches that are presently being used to select effective control measures for the management of nanomaterials, more specifically control banding tools presently in use. Significant changes can be found in the following sections: ‘Hazard Banding’, ‘Exposure Control’, ‘Toxicology’, and ‘Monitoring’.

Of relevance to employers, managers, health and safety advisors, and users of particulate nanomaterials in research and development, the guidance should be read in conjunction with the Approved Code of Practice on COSHH [Control of Substances Hazardous to Health], together with the other literature referred to in the document. The document has been produced taking account of the safety information currently available and is presented in the format of guidance and recommendations to support implementation of suitable protocols and control measures by employers and employees. It is intended that the document will be reviewed and updated on a periodic basis to keep abreast of the evolving nature of the content.

The guidance titled “Working Safely with Nanomaterials in Research & Development” is about 48 pp. and can be found here.

Tidbit about US nano environmental, health, and safety

Sylvia Palmer has written a May 27, 2016 update for ChemicalWatch on reports about or including information about environmental, health, and safety measures being taken in the US,

Three reports released recently by the National Nanotechnology Initiative (NNI) highlight the US government’ investments and initiatives in nanotechnology. They also detail current progress and the need for further understanding of exposure to nanomaterials in consumer products –and how companies can protect their nanotechnology workforce.

NNI’s Quantifying exposure to engineered nanomaterials (QEEN) from manufactured products: addressing environmental, health, and safety implications notes significant progress has been made in the ability to quantify nanomaterial exposures. However, it says greater understanding of exposure risks in “real-world” scenarios is needed. Alternative testing models and high-throughput methods for rapidly estimating exposures will be further explored, it adds.

You can find the report, Quantifying exposure to engineered nanomaterials (QEEN) from manufactured products: addressing environmental, health, and safety implications, here. Palmer’s article briefly describes the other two reports which contain information about US nano environmental, health, and safety efforts.

There is more about the three reports in an April 11, 2016 posting by Lloyd Whitman (Assistant Director for Nanotechnology and Advanced Materials, White House Office of Science and Technology Policy) and Treye Thomas (leader of the Chemical Hazards Program team in the U.S. Consumer Product Safety Commission, and Coordinator for Environmental, Health, and Safety Research under the National Nanotechnology Initiative) on the White House blog,

The recently released NNI Supplement to the President’s Budget for Fiscal Year 2017, which serves as the annual report for the NNI, highlights the programs and coordinated activities taking place across the many departments, independent agencies, and commissions participating today in the NNI—an initiative that continues to serve as a model for effective coordination of Federal science and technology R&D. As detailed in this report, nanoEHS activities continue to account for about 10 percent of the annual NNI budget, with cumulative Federal R&D investments in this area exceeding $1 billion over the past decade. This report includes descriptions of a wide variety of individual agency and coordinated activities supporting the responsible development of nanotechnology.

To understand and control the risks of using any new materials in consumer products, it is important to understand the potential for exposure and any associated hazards across product life cycles. Last month, the NNI released a report, Quantifying Exposure to Engineered Nanomaterials (QEEN) from Manufactured Products: Addressing Environmental, Health, and Safety Implications, summarizing a workshop on this topic sponsored by the U.S. Consumer Product Safety Commission (CPSC). The main goals of the workshop were to assess progress in developing tools and methods for quantifying exposure to engineered nanomaterials across the product life cycle, and to identify new research needed to advance exposure assessment for nanotechnology-enabled products. …

The technical experts who participated in CPSC’s workshop recommended that future work focus on the complex issue of determining biomarkers of exposure linked to disease, which will require substantive public–private collaboration, partnership, and knowledge sharing. Recognizing these needs, the President’s 2017 Budget request for CPSC includes funds for a new nanotechnology center led by the National Institute of Environmental Health Sciences (NIEHS) to develop test methods and to quantify and characterize the presence, release, and mechanisms of consumer exposure to nanomaterials in consumer products. This cost-effective, interagency collaboration will enable CPSC—through NIEHS—to collect the needed data to inform the safety of nanotechnology in consumer products and allow CPSC to benefit from NIEHS’s scientific network and experience.

Managing EHS risks across a product’s lifecycle includes protecting the workers who manufacture those products. The National Institute for Occupational Safety and Health has issued a series of documents providing guidance to this emerging industry, including the recently released publication Building a Safety Program to Protect the Nanotechnology Workforce: A Guide for Small to Medium-Sized Enterprises. This guide provides business owners with the tools necessary to develop and implement a written health and safety program to protect their employees.

Whitman also mentions a June 2016 international conference in the context of this news,

The responsible development of nanotechnology is a goal that the United States shares with many countries. The United States and the European Union are engaged in notable cooperation on this front. European and American scientists engaged in nanoEHS research convene annually for a joint workshop to identify areas of shared interest and mechanisms for collaboration to advance nanoEHS science. The 2016 joint workshop will be held on June 6–7, 2016 in Arlington, VA, and is free and open to the public. …

More from PETA (People for the Ethical Treatment of Animals) about nanomaterials and lungs

Science progress by increments. First, there was this April 27, 2016 post featuring some recent work by the organization, People for the Ethical Treatment of Animals (PETA) focused on nanomaterials and lungs. Now approximately one month later, PETA announces a new paper on the topic according to a May 26, 2016 news item on phys.org,

A scientist from the PETA International Science Consortium Ltd. is the lead author of a review on pulmonary fibrosis that results from inhaling nanomaterials, which has been published in Archives of Toxicology. The coauthors are scientists from Health Canada, West Virginia University, and the University of Fribourg in Switzerland.

A May 26, 2016 PETA news release on EurekAlert, which originated the news item, provides more detail (Note: Links have been removed),

The increasing use of nanomaterials in consumer goods such as paint, building materials, and food products has increased the likelihood of human exposure. Inhalation is one of the most prominent routes by which exposure can occur, and because inhalation of nanomaterials may be linked to lung problems such as pulmonary fibrosis, testing is conducted to assess the safety of these materials.

The review is one part of the proceedings of a 2015 workshop [mentioned in my Sept. 3, 2015 posting] organized by the PETA International Science Consortium, at which scientists discussed recommendations for designing an in vitro approach to assessing the toxicity of nanomaterials in the human lung. The workshop also produced another report that was recently published in Archives of Toxicology (Clippinger et al. 2016) and a review published in Particle and Fibre Toxicology (Polk et al. 2016) [mentioned in my April 27, 2016 posting] on exposing nanomaterials to cells grown in vitro.

The expert recommendations proposed at the workshop are currently being used to develop an in vitro system to predict the development of lung fibrosis in humans, which is being funded by the Science Consortium.

“International experts who took part in last year’s workshop have advanced the understanding and application of non-animal methods of studying nanomaterial effects in the lung,” says Dr. Monita Sharma, nanotoxicology specialist at the Consortium and lead author of the review in Archives of Toxicology. “Good science is leading the way toward more humane testing of nanomaterials, which, in turn, will lead to better protection of human health.”

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

Predicting pulmonary fibrosis in humans after exposure to multi-walled carbon nanotubes (MWCNTs) by Monita Sharma, Jake Nikota, Sabina Halappanavar, Vincent Castranova, Barbara Rothen-Rutishauser, Amy J. Clippinger. Archives of Toxicology pp 1-18 DOI: 10.1007/s00204-016-1742-7 First online: 23 May 2016

This paper is behind a paywall.