Tag Archives: Friends of the Earth

Walgreens (US-based pharmacy), As You Sow (civil society), and engineered hydroxyapatite (HA) nanoparticles

As You Sow has graced this blog before, notably in a March 13, 2015 posting about their success getting the corporate giant, Dunkin’ Donuts, to stop its practice of making powdered sugar whiter by adding nanoscale (and other scales) of titanium dioxide. What’s notable about As You Sow is that it files shareholder resolutions (in other words, the society owns shares of their corporate target) as one of its protest tactics.

This time, As You Sow has focused on Walgreens, a US pharmacy giant. This company has chosen a response that differs from Dunkin’ Donuts’ according to a Sept. 21, 2016 news item on Nanotechnology Now,

Rather than respond to shareholder concerns that Walgreens’ store-brand infant formula may contain harmful, “needle-like” nanomaterials, Walgreens filed a motion with the SEC [US Securities and Regulatory Commission] to block the inquiry.

A Sept. 21, 2016 As You Sow press release, which originated the news item, fills in a few details,

Walgreen’s Well Beginnings™ Advantage® infant formula has been reported to contain engineered hydroxyapatite (HA) nanoparticles, according to independent laboratory testing commissioned by nonprofit group Friends of the Earth. The E.U. Scientific Committee on Consumer Safety (SCCS) has determined that nano-HA may be toxic to humans and that the needle-form of nano-HA should not be used in products.

Walgreens’ “no-action letter” to the SEC argues that the company can exclude the shareholder proposal because “the use of nanomaterials in products … does not involve a significant social policy issue.” The company also claims its infant formula does not contain engineered nanomaterials, contrary to the independent laboratory testing.

“Walgreens is effectively silencing shareholder discussion of this subject,” said Austin Wilson, Environmental Health Program Manager of shareholder advocacy group As You Sow. “If Walgreens had responded to consumers’ and investors’ concerns, there would be no need for shareholders to file a proposal.”

“Shareholders will ultimately bear the burden of litigation if infants are harmed,” said Danielle Fugere, President and Chief Counsel of As You Sow. “Walgreens’ attempt to silence, rather than address, shareholder concerns raises red flags. To be successful, Walgreens must remain a trusted name for consumers and it can’t do that by sweeping new health studies under the rug.”

Nanoparticles are extremely small particles that can permeate cell membranes and travel throughout the body, including into organs, in ways that larger ingredients cannot. The extremely small size of nanoparticles may result in greater toxicity for human health and the environment.

The shareholder proposal asks the company to issue a report about actions the company is taking to reduce or eliminate the risk of nanoparticles.

In 2014, Dunkin’ Donuts reached an agreement with As You Sow to remove the nanoparticle titanium dioxide from its donuts. Starbucks plans to remove it from all products by 2017, and Krispy Kreme is reformulating its products to exclude titanium dioxide and other nanoparticles.

To seemingly dismiss concerns about their brand infant formula appears to be an odd tactic for Walgreens. After all this is infant safety and it’s the kind of thing that makes people very, very angry. On the other hand, Friends of the Earth has not always been scrupulous in its presentation of ‘facts’ (see my Feb. 9, 2012 posting).

2016 hasn’t been a good year for Walgreens. In June they ended their high profile partnership with blood testing startup, Theranos. From a June 13, 2016 article by Abigail Tracy for Vanity Fair,

After months of getting pummeled at the hands of regulators and the media over its questionable blood-testing technology, Theranos may have just been dealt its final blow. Walgreens, the main source of Theranos’s customers, has officially ended its partnership with the embattled biotech company, cutting off a critical revenue stream for founder Elizabeth Holmes’s once-promising start-up.

In a statement issued Sunday [June 12, 2016], the drugstore chain announced that it was terminating its nearly three-year-long relationship with the once $9 billion company and would immediately close all 40 Theranos-testing locations in its Arizona stores, The Wall Street Journal reports. Like so many in Silicon Valley, Walgreens fell victim to Holmes’s claims that Theranos’s technology, and its proprietary diagnostic product, Edison, would revolutionize blood testing and put its rivals, Laboratory Corporation of America and Quest Diagnostics, out of business. When it inked its deal with Holmes in 2013, Walgreens failed to properly vet the Edison technology, which was billed as being capable of conducting hundreds of diagnostics tests with just a few drops of blood.

You can read more about the Theranos situation in Tracy’s June 13, 2016 article and I have some details in a Sept. 2, 2016 posting where I feature the scandal and the proposed movie about Theranos (and other ‘science’ movies).

Getting back to Walgreens, you can find the As You Sow resolution here.

Public comment invited on *2016* US draft National Nanotechnology Initiative strategic plan

A Sept. 23, 2016 news item on Nanowerk announces a public consultation on the latest draft US National Nanotechnology Initiative strategic plan (Note: Links have been removed),

The draft 2016 National Nanotechnology Initiative (NNI) Strategic Plan is now available online for public comment prior to publication. The public is encouraged to submit comments electronically through www.nano.gov/2016strategy, or via email to 2016NNIStrategy@nnco.nano.gov. Public comments should be one page or less and include reference page and line numbers. Comments are due by September 23, 2016. Additional guidance is available in the Federal Register.

The NNI Strategic Plan describes the initiative’s vision and goals and the strategies by which these goals are to be achieved. The plan includes a description of the NNI investment strategy and the program component areas called for by the 21st Century Research and Development Act of 2003, and it also identifies specific objectives toward collectively achieving the NNI vision. This plan updates and replaces the NNI Strategic Plan of February 2014.

A Sept. 12, 2016 US National Nanotechnology Initiative notice provides a link to the 67pp. draft document and further information. You can also check the US Federal Register for the official document. The deadline for submitting comments is Sept. 23, 2016, in short, you have ten days.

*ETA Sept. 15, 2016: Sam Pearson in a Sept. 14, 2016 article (open access during a free trial) for Bloomberg BNA offers some analysis of the 2016 draft plan,

The draft document, which sets out goals for developing and commercializing the technology and was released Sept. 12 [2016], is largely unchanged from previous versions. The plan, which is required under the 21st Century Nanotechnology Research and Development Act, sets policy for the White House-led National Nanotechnology Initiative for the next three years across 20 departments and independent agencies.

The environment and health spending is about 7 percent of the initiative’s total budget, an increase from 4.8 percent in fiscal year 2011 and just 2.8 percent in fiscal year 2006. When combined with related spending in other sectors, the total is about 10 percent of the budget, the document states.

“There’s significant potential positive aspects of this, but we need those to be managed in a mature way to ensure that we’re not bringing about something that’s so profound without any laws in place,” Ian Illuminato, a health and environment consultant at Friends of the Earth, told Bloomberg BNA Sept. 12 [2016], “which has so far been what’s happening.”

Friends of the Earth and other environmental groups have pushed for tougher evaluations of the potential health risks of nanotech products.

In a statement to Bloomberg BNA Sept. 12 [2016], Jay West, head of the Nanotechnology Panel of the American Chemistry Council, said the group planned to examine the proposal.

For the curious, there’s more analysis in Pearson’s article.

*’2016′ added on Sept. 15, 2016.

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.

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.

Risk assessments not the only path to nanotechnology regulation

Nanowerk has republished an essay about nanotechnology regulation from Australia’s The Conversation in an Aug. 25, 2015 news item (Note: A link has been removed),

When it comes to nanotechnology, Australians have shown strong support for regulation and safety testing.

One common way of deciding whether and how nanomaterials should be regulated is to conduct a risk assessment. This involves calculating the risk a substance or activity poses based on the associated hazards or dangers and the level of exposure to people or the environment.

However, our recent review (“Risk Analysis of Nanomaterials: Exposing Nanotechnology’s Naked Emperor”) found some serious shortcomings of the risk assessment process for determining the safety of nanomaterials.

We have argued that these shortcomings are so significant that risk assessment is effectively a naked emperor [reference to a children’s story “The Emperor’s New Clothes“].

The original Aug. 24, 2015 article written by Fern Wickson (Scientist/Program Coordinator at GenØk – Centre for Biosafety in Norway) and Georgia Miller (PhD candidate at UNSW [University of New South Wales], Australia) points out an oft ignored issue with regard to nanotechnology regulation,

Risk assessment has been the dominant decision-aiding tool used by regulators of new technologies for decades, despite it excluding key questions that the community cares about. [emphasis mine] For example: do we need this technology; what are the alternatives; how will it affect social relations, and; who should be involved in decision making?

Wickson and Miller also note more frequently discussed issues,

A fundamental problem is a lack of nano-specific regulation. Most sector-based regulation does not include a “trigger” for nanomaterials to face specific risk assessment. Where a substance has been approved for use in its macro form, it requires no new assessment.

Even if such a trigger were present, there is also currently no cross-sectoral or international agreement on the definition of what constitutes a nanomaterial.

Another barrier is the lack of measurement capability and validated methods for safety testing. We still do not have the means to conduct routine identification of nanomaterials in the complex “matrix” of finished products or the environment.

This makes supply chain tracking and safety testing under real-world conditions very difficult. Despite ongoing investment in safety research, the lack of validated test methods and different methods yielding diverse results allows scientific uncertainty to persist.

With regard to the first problem, the assumption that if a material at the macroscale is safe, then the same is true at the nanoscale informs regulation in Canada and, as far as I’m aware, every other constituency that has any type of nanomaterial regulation. I’ve had mixed feelings about this. On the one hand, we haven’t seen any serious problems associated with the use of nanomaterials but on the other hand, these problems can be slow to emerge.

The second issue mentioned, the lack of a consistent definition internationally, seems to be a relatively common problem in a lot of areas. As far as I’m aware, there aren’t that many international agreements for safety measures. Nuclear weapons and endangered animals and plants (CITES) being two of the few that come to mind.

The lack of protocols for safety testing of nanomaterials mentioned in the last paragraph of the excerpt is of rising concern. For example, there’s my July 7, 2015 posting featuring two efforts: Nanotechnology research protocols for Environment, Health and Safety Studies in US and a nanomedicine characterization laboratory in the European Union. Despite this and other efforts, I do think more can and should be done to standardize tests and protocols (without killing new types of research and results which don’t fit the models).

The authors do seem to be presenting a circular argument with this (from their Aug. 24, 2015 article; Note: A link has been removed),

Indeed, scientific uncertainty about nanomaterials’ risk profiles is a key barrier to their reliable assessment. A review funded by the European Commission concluded that:

[…] there is still insufficient data available to conduct the in depth risk assessments required to inform the regulatory decision making process on the safety of NMs [nanomaterials].

Reliable assessment of any chemical or drug is a major problem. We do have some good risk profiles but how many times have pharmaceutical companies developed a drug that passed successfully through human clinical trials only to present a serious risk when released to the general population? Assessing risk is a very complex problem. even with risk profiles and extensive testing.

Unmentioned throughout the article are naturally occurring nanoparticles (nanomaterials) and those created inadvertently through some manufacturing or other process. In fact, we have been ingesting nanomaterials throughout time. That said, I do agree we need to carefully consider the impact that engineered nanomaterials could have on us and the environment as ever more are being added.

To that end, the authors make some suggestions (Note: Links have been removed),

There are well-developed alternate decision-aiding tools available. One is multicriteria mapping, which seeks to evaluate various perspectives on an issue. Another is problem formulation and options assessment, which expands science-based risk assessment to engage a broader range of individuals and perspectives.

There is also pedigree assessment, which explores the framing and choices taking place at each step of an assessment process so as to better understand the ambiguity of scientific inputs into political processes.

Another, though less well developed, approach popular in Europe involves a shift from risk to innovation governance, with emphasis on developing “responsible research and innovation”.

I have some hesitation about recommending this read due to Georgia Miller’s involvement and the fact that I don’t have the time to check all the references. Miller was a spokesperson for Friends of the Earth (FoE) Australia, a group which led a substantive campaign against ‘nanosunscreens’. Here’s a July 20, 2010 posting where I featured some cherrypicking/misrepresentation of data by FoE in the persons of Georgia Miller and Ian Illuminato.

My Feb. 9, 2012 posting highlights the unintended consequences (avoidance of all sunscreens by some participants in a survey) of the FoE’s campaign in Australia (Note [1]: The percentage of people likely to avoid all sunscreens due to their concerns with nanoparticles in their sunscreens was originally reported to be 17%; Note [2]: Australia has the highest incidence of skin cancer in the world),

Feb.21.12 correction: According to the information in the Feb. 20, 2012 posting on 2020 Science, the percentage of Australians likely to avoid using sunscreens is 13%,

This has just landed in my email in box from Craig Cormick at the Department of Industry, Innovation, Science, Research and Tertiary Education in Australia, and I thought I would pass it on given the string of posts on nanoparticles in sunscreens on 2020 Science over the past few years:

“An online poll of 1,000 people, conducted in January this year, shows that one in three Australians had heard or read stories about the risks of using sunscreens with nanoparticles in them,” Dr Cormick said.

“Thirteen percent of this group were concerned or confused enough that they would be less likely to use any sunscreen, whether or not it contained nanoparticles, putting them selves at increased risk of developing potentially deadly skin cancers.

“The study also found that while one in five respondents stated they would go out of their way to avoid using sunscreens with nanoparticles in them, over three in five would need to know more information before deciding.”

This article with Fern Wickson (with whom I don’t always agree perfectly but hasn’t played any games with research that I’m know of) helps somewhat but it’s going to take more than this before I feel comfortable recommending Ms. Miller’s work for further reading.

FOE, nano, and food: part three of three (final guidance)

The first part of this food and nano ‘debate’ started off with the May 22, 2014 news item on Nanowerk announcing the Friends of the Earth (FOE) report ‘Way too little: Our Government’s failure to regulate nanomaterials in food and agriculture‘. Adding energy to FOE’s volley was a Mother Jones article written by Tom Philpott which had Dr. Andrew Maynard (Director of the University of Michigan’s Risk Science Center) replying decisively in an article published both on Nanowerk and on the Conversation.

The second part of this series focused largely on a couple of  research efforts (a June 11, 2014 news item on Nanowerk highlights a Franco-German research project, SolNanoTox) and in the US (a  June 19, 2014 news item on Azonano about research from the University of Arizona focusing on nanoscale additives for dietary supplement drinks) and noted another activist group’s (As You Sow) initiative with Dunkin’ Donuts (a July 11, 2014 article by Sarah Shemkus in a sponsored section in the UK’s Guardian newspaper0).

This final part in the series highlights the US Food and Drug Administration’s (FDA) final guidance document on nanomaterials and food issued some five weeks after the FOE’s report and an essay by a Canadian academic on the topic of nano and food.

A July 9, 2014 news item on Bloomberg BNA sums up the FDA situation,

The Food and Drug Administration June 24 [2014] announced new guidance to provide greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products, including drugs, devices, cosmetics and food.

In this final guidance, the agency said that nanotechnology “can be used in a broad array of FDA-regulated products, including medical products (e.g., to increase bioavailability of a drug), foods (e.g., to improve food packaging) and cosmetics (e.g., to affect the look and feel of cosmetics).”

Also on the agency website, the FDA said it “does not make a categorical judgment that nanotechnology is inherently safe or harmful. We intend our regulatory approach to be adaptive and flexible and to take into consideration the specific characteristics and the effects of nanomaterials in the particular biological context of each product and its intended use.”

This July 18, 2014 posting by Jeannie Perron, Miriam Guggenheimm and Allan J. Topol of Covington & Burling LLP on the National Law Review blog provides a better summary and additional insight,

On June 24, 2014, the Food and Drug Administration (FDA) released three final guidance documents addressing the agency’s general approach to nanotechnology and its use by the food and cosmetics industries, as well as a draft guidance on the use of nanomaterials in food for animals.

These guidance documents reflect FDA’s understanding of nanomaterials as an emerging technology of major importance with the potential to be used in novel ways across the entire spectrum of FDA- regulated products.

The documents suggest that FDA plans to approach nanotechnology-related issues cautiously, through an evolving regulatory structure that adapts to manufacturers’ changing uses of this technology. FDA has not established regulatory definitions of “nanotechnology,” “nanomaterial,” “nanoscale,” or other related terms. …

The notion of an “evolving regulatory structure” is very appealing in situations with emerging technologies with high levels of uncertainty. It’s surprising that more of the activist groups don’t see an opportunity with this approach. An organization that hasn’t devised a rigid regulatory structure has no investment in defending it. Activist groups can make the same arguments, albeit from a different perspective, about an emerging technology as the companies do and, theoretically, the FDA has become a neutral party with the power to require a company to prove its products’ safety.

You can find the FDA final guidance and other relevant documents here.

Finally, Sylvain Charlebois, associate dean at the College of Business and Economics at the University of Guelph, offers a rather provocative (and not from the perspective you might expect given his credentials) opinion on the topic of ‘nano and food’  in a July 18, 2014 article for TheRecord.com,

Nanotechnology and nanoparticles have been around for quite some time. In fact, consumers have been eating nanoparticles for years without being aware they are in their food.

Some varieties of Dentyne gum and Jell-O, M&M’s, Betty Crocker whipped cream frosting, Kool-Aid, Pop-Tarts, you name it, contain them. Even food packaging, such as plastic containers and beer bottles, have nanoparticles.

While consumers and interest groups alike are registering their concerns about genetically modified organisms, the growing role of nanotechnology in food and agriculture is impressive. When considering the socio-economic and ethical implications of nanotechnology, comparisons to the genetic modification debate are unavoidable.

The big picture is this. For years, capitalism has demonstrated its ability to create wealth while relying on consumers’ willingness to intrinsically trust what is being offered to them. With trans fats, genetically modified organisms and now nanoparticles, our food industry is literally playing with fire. [emphasis mine]

Most consumers may not have the knowledge to fully comprehend the essence of what nanotechnology is or what it can do. However, in an era where data access in almost constant real-time is king, the industry should at least give public education a shot.

In the end and despite their tactics, the activist groups do have a point. The food and agricultural industries need to be more frank about what they’re doing with our food. As Charlebois notes, they might want to invest in some public education, perhaps taking a leaf out of the Irish Food Board’s book and presenting the public with information both flattering and nonflattering about their efforts with our food.

Part one (an FOE report is published)

Part two (the problem with research)

ETA Aug. 22, 2014: Coincidentally, Michael Berger has written an Aug. 22, 2014 Nanowerk Spotlight article titled: How to identify nanomaterials in food.

ETA Sept. 1, 2014: Even more coincidentally, Michael Berger has written a 2nd Nanowerk Spotlight (dated Aug. 25, 2014) on the food and nano topic titled, ‘Nanotechnology in Agriculture’ based on the European Union’s Joint Research Centre’s ‘Workshop on Nanotechnology for the agricultural sector: from research to the field”, held on November 21-22 2013’.

FOE, nano, and food: part two of three (the problem with research)

The first part of this roughly six week food and nano ‘debate’ started off with the May 22, 2014 news item on Nanowerk announcing the Friends of the Earth (FOE) report ‘Way too little: Our Government’s failure to regulate nanomaterials in food and agriculture‘. Adding energy to FOE’s volley was a Mother Jones article written by Tom Philpott which had Dr. Andrew Maynard (Director of the University of Michigan’s Risk Science Center) replying decisively in an article published both on Nanowerk and on the Conversation.

Coincidentally or not, there were a couple of news items about ‘nano and food’ research efforts during the ‘debate’. A June 11, 2014 news item on Nanowerk highlights a Franco-German research project into the effects that nanomaterials have on the liver and the intestines while noting the scope of the task researchers face,

What mode of action do nanomaterials ingested via food have in liver and intestine? Which factors determine their toxicity? Due to the large number of different nanomaterials, it is hardly possible to test every one for its toxic properties. [emphasis mine] For this reason, specific properties for the classification of nanomaterials are to be examined within the scope of the Franco-German research project “SolNanoTox”, which began on 1 March 2014. The [German] Federal Institute for Risk Assessment (BfR) requires data on bioavailability for its assessment work, in particular on whether the solubility of nanomaterials has an influence on uptake and accumulation in certain organs, such as liver and intestine. “We want to find out in our tests whether the criterion ‘soluble or insoluble’ is a determining factor for uptake and toxicity of nanomaterials,” says BfR President Professor Dr. Andreas Hensel.

A June 13, 2014 German Federal Institute for Risk Assessment (BfR) press release, which originated the news item, details the research and the participating agencies,

A risk assessment of nanomaterials is hardly possible at the moment and involves a very high degree of uncertainty, as important toxicological data on their behaviour in tissue and cells are still missing. [emphasis mine] The German-French SolNanoTox research project examines which role the solubility of nanomaterials plays with regard to their accumulation and potential toxic properties. The project is to run for three and a half years during which the BfR will work closely with its French sister organisation ANSES. Other partners are the Institut des Sciences Chimiques de Rennes and Universität Leipzig. The German Research Foundation and French Agence Nationale de la Recherche (ANR) are funding the project.

The tasks of the BfR include in vitro tests (e.g. the investigation of the influence of the human gastrointestinal system) and analysis of biological samples with regard to the possible accumulation of nanomaterials. In addition to this, the BfR uses modern methods of mass spectrometry imaging to find out whether nanoparticles alter the structure of biomolecules, e.g. the structure of the lipids of the cellular membrane. So far, these important tests, which are necessary for assessing possible changes in DNA or cellular structures caused by nanomaterials in food, have not been conducted.

Metallic nanoparticles are to be studied (from the press release),

In the project, two fundamentally different types of nanoparticles are examined as representatives for others of their type: titanium dioxide as representative of water insoluble nanoparticles and aluminium as an example of nanomaterials which show a certain degree of water solubility after oxidation. [emphases mine] It is examined whether the degree of solubility influences the distribution of the nanomaterials in the body and whether soluble materials may possibly accumulate more in other organs than insoluble ones. The object is to establish whether there is a direct toxic effect of insoluble nanomaterials in general after oral uptake due to their small size.

Different innovative analytical methods are combined in the project with the aim to elucidate the behaviour of nanomaterials in tissue and their uptake into the cell. The main focus is on effects which can trigger genotoxic damage and inflammation. At first, the effects of both materials are examined in human cultures of intestinal and liver cells in an artificial environment (in vitro). In the following, it has to be verified by animal experimentation whether the observed effects can also occur in humans. This modus operandi allows to draw conclusions on effects and mode of action of orally ingested nanomaterials with different properties. The goal is to group nanomaterials on the basis of specific properties and to allocate the corresponding toxicological properties to these groups. Motivation for the project is the enormous number of nanomaterials with large differences in physicochemical properties. Toxicological tests cannot be conducted for all materials.

In the meantime, a June 19, 2014 news item on Azonano (also on EurekAlert but dated June 18, 2014) features some research into metallic nanoparticles in dietary supplement drinks,

Robert Reed [University of Arizona] and colleagues note that food and drink manufacturers use nanoparticles in and on their products for many reasons. In packaging, they can provide strength, control how much air gets in and out, and keep unwanted microbes at bay. As additives to food and drinks, they can prevent caking, deliver nutrients and prevent bacterial growth. But as nanoparticles increase in use, so do concerns over their health and environmental effects. Consumers might absorb some of these materials through their skin, and inhale and ingest them. What doesn’t get digested is passed in urine and feces to the sewage system. A handful of initial studies on nanomaterials suggest that they could be harmful, but Reed’s team wanted to take a closer look.

They tested the effects of eight commercial drinks containing nano-size metal or metal-like particles on human intestinal cells in the lab. The drinks changed the normal organization and decreased the number of microvilli, finger-like projections on the cells that help digest food. In humans, if such an effect occurs as the drinks pass through the gastrointestinal tract, these materials could lead to poor digestion or diarrhea, they say. The researchers’ analysis of sewage waste containing these particles suggests that much of the nanomaterials from these products are likely making their way back into surface water, where they could potentially cause health problems for aquatic life.

This piece is interesting for two reasons. First, the researchers don’t claim that metallic nanoparticles cause digestion or diarrhea due to any action in the gastrointestinal tract. They studied the impact that metallic nanoparticles in supplementary drinks had on cells (in vitro testing) from the gastrointestinal tract. Based on what they observed in the laboratory, “… these materials could lead to poor digestion or diarrhea… .” The researchers also suggest a problem could occur as these materials enter surface water in increasing quantities.

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

Supplement Drinks and Assessment of Their Potential Interactions after Ingestion by Robert B. Reed, James J. Faust, Yu Yang, Kyle Doudrick, David G. Capco, Kiril Hristovski, and Paul Westerhoff. ACS Sustainable Chem. Eng., 2014, 2 (7), pp 1616–1624 DOI: 10.1021/sc500108m Publication Date (Web): June 2, 2014

Copyright © 2014 American Chemical Society

With Paul Westerhoff as one of the authors and the reference to metallic nanoparticles entering water supplies, I’m guessing that this research is associated with the LCnano (lifecycle nano) project headquartered at Arizona State university (April 8, 2014 posting).

Getting back to the Franco-German SolNanoTox project, scientists do not know what happens when the cells in your intestines, liver, etc. encounter metallic or other nanoparticles, some of which may be naturally occurring. It should also be noted that we have likely been ingesting metallic nanoparticles for quite some time. After all, anyone who has used silver cutlery has ingested some silver nanoparticles.

There are many, many questions to be asked and answered with regard to nanomaterials in our foods.  Here are a few of mine:

  • How many metallic and other nanoparticles did we ingest before the advent of ‘nanomaterials in food’?
  • What is the biopersistence of naturally occurring and engineered metallic and other nanoparticles in the body?
  • Is there an acceptable dose versus a fatal dose? (Note: There’s naturally occurring formaldehyde in pears as per my May 19, 2014 post about doses, poisons, and the Sense about Science group’s campaign/book, Making Sense of Chemical Stories.)
  • What happens as the metallic and other engineered nanoparticles are added to food and drink and eventually enter our water, air, and soil?

Returning to the ‘debate’, a July 11, 2014 article by Sarah Shemkus for a sponsored section in the UK’s Guardian newspaper highlights an initiative taken by an environmental organization, As You Sow, concerning titanium dioxide in Dunkin’ Donuts’ products (Note: A link has been removed),

The activists at environmental nonprofit As You Sow want you to take another look at your breakfast doughnut. The organization recently filed a shareholder resolution asking Dunkin’ Brands, the parent company of Dunkin’ Donuts, to identify products that may contain nanomaterials and to prepare a report assessing the risks of using these substances in foods.

Their resolution received a fair amount of support: at the company’s annual general meeting in May, 18.7% of shareholders, representing $547m in investment, voted for it. Danielle Fugere, As You Sow’s president, claims that it was the first such resolution to ever receive a vote. Though it did not pass, she says that she is encouraged by the support it received.

“That’s a substantial number of votes in favor, especially for a first-time resolution,” she says.

The measure was driven by recent testing sponsored by As You Sow, which found nanoparticles of titanium dioxide in the powdered sugar that coats some of the donut chain’s products. [emphasis mine] An additive widely used to boost whiteness in products from toothpaste to plastic, microscopic titanium dioxide has not been conclusively proven unsafe for human consumption. Then again, As You Sow contends, there also isn’t proof that it is harmless.

“Until a company can demonstrate the use of nanomaterials is safe, we’re asking companies either to not use them or to provide labels,” says Fugere. “It would make more sense to understand these materials before putting them in our food.”

As You Sow is currently having 16 more foods tested. The result should be available later this summer, Fugere says.

I wonder if As You Sow will address the question of whether the nanoscale titanium dioxide they find indicates that nanoscale particles are being deliberately added or whether the particles are the inadvertent consequence of the production process. That said, I find it hard to believe no one in the food industry is using engineered nanoscale additives as they claim  (the other strategy is to offer a nonanswer) in Shemkus’ article (Note: Links have been removed).,

In a statement, Dunkin’ Donuts argues that the titanium dioxide identified by As You Sow does not qualify as a nanomaterial according to European Union rules or draft US Food and Drug Administration regulations. The company also points out that there is no agreed-upon standard method for identifying nanoparticles in food.

In 2008, As You Sow filed nanomaterial labeling resolutions with McDonald’s and Kraft Foods. In response, McDonald’s released a statement declaring that it does not support the use of nanomaterials in its food, packaging or toys. Kraft responded that it would make sure to address health and safety concerns before ever using nanomaterials in its products.

While Shemkus’ article appears in the Guardian’s Food Hub which is sponsored by the Irish Food Board, this article manages to avoid the pitfalls found in Philpott’s nonsponsored article.

Coming next: the US Food and Drug Administration Guidance issued five weeks after the FOE kicks off the ‘nano and food’ debate in May 2014 with its ‘Way too little: Our Government’s failure to regulate nanomaterials in food and agriculture‘ report.

Part one (an FOE report is published)

Part three (final guidance)

FOE, nano, and food: part one of three (an FOE report is published)

It seems the food and nano debate of Spring/Summer 2014 has died down, for a while at least. The first volley (from my perspective) was the May 2014 release of ‘Way too little: Our Government’s failure to regulate nanomaterials in food and agriculture’ by the Friends of the Earth (FOE) Australia. Here’s how the report is described in a May 22, 2014 news item on Nanowerk,

Friends of the Earth’s new report, Way too little (pdf), looks at the now widespread presence of nanomaterials in our food chain and how little Food Standards Australia New Zealand (FSANZ) is doing to ensure our safety.

You can find the following passage on p. 6 of FOE’s report ‘Way too little: Our Government’s failure to regulate nanomaterials in food and agriculture‘,

This report will examine the changes since our 2008 report including the development of new food, food contact and agricultural products. It will review the current literature relating to the potential environmental, health and safety impacts associated with nanotechnology and summarise the Australian regulatory responses to date.

This updated report uncovers the:

•accelerating rate of commercialisation and rapidly increasing number of commercial products containing nanomaterials in the food and agricultural sectors;

•lack of information regarding which nanomaterials have been released and the likely exposure of humans and natural systems to these materials;

•lack of basic steps to allow us to track nanomaterials that have been released, such as
labelling and a register of products containing nanomaterials;

•growing gap between the pace of commercialisation and environmental, health and safety assessments;

•increasingly large body of peer reviewed evidence that certain nanomaterials may cause harm to human health or the environment;

•failure of regulators to respond to the growingevidence of risks;

•lack of basic knowledge that is critical in order to fully analyse the particular environmental, health and safety issues associated with nanotechnology.

Six years ago, inaction was based on a perceived lack of data. Inaction is still the norm but that is no longer an excuse our Government can use. Scientists and scientific bodies such as the US National Research Council have given us more than enough evidence to justify a pro-active regulatory regime and a properly funded R&D program that will effectively target those areas of greatest environmental and health concern.

Unfortunately, our Federal Government seems unwilling to provide the levels of funding required for such work or to adopt appropriate regulation. The notion of precaution has been replaced with an attitude that it is the obligation of industry to determine whether their products are safe and regulators will only act when harm is shown. While France, Belgium and Denmark are implementing a mandatory register for nanomaterials and the EU’s is in the process of implementing a nano food labelling regime, Australian consumers remain in the dark.

This needs to change.

One of the issues with increased regulation and labeling is whether the benefits outweigh disadvantages such as the increased difficulty of getting needed foodstuffs to the marketplace and, of course, cost.

Tom Philpott in a May 28, 2014 article for Mother Jones magazine titled ‘Big Dairy Is Putting Microscopic Pieces of Metal in Your Food’ is a strong proponent for FOE’s position, albeit his geographic focus is the US and he seems most concerned with metallic nanoparticles (Note: Links have been removed),

Examples include Silk Original Soy Milk, Rice Dream Rice Drink, Hershey’s Bliss Dark Chocolate, and Kraft’s iconic American Cheese Singles, all of which now contain nano-size titanium dioxide*. As recently as 2008, only eight US food products were known to contain nanoparticles, according to a recent analysis [May 2014 report] from Friends of the Earth—a more than tenfold increase in just six years.

Philpott goes on to mention the US Food and Drug Administration’s (FDA) 2012 draft guidance on nanomaterials and food,

Back in 2012, the FDA released a draft, pending public comment, of a proposed new framework for bringing nano materials into food. The document reveals plenty of reason for concern. For example: “so-called nano-engineered food substances can have significantly altered bioavailability and may, therefore, raise new safety issues that have not been seen in their traditionally manufactured counterparts.” The report went on to note that “particle size, surface area, aggregation/agglomeration, or shape may impact absorption, distribution, metabolism and excretion (ADME) and potentially the safety of the nano-engineered food substance.”

What FDA is saying here is obvious: If nanoparticles didn’t behave differently, the industry wouldn’t be using them in the first place.

So what’s the remedy? Rather than require rigorous safety studies before companies can lace food with nanoparticles, the FDA’s policy draft proposes “nonbinding recommendations” for such research. Even that rather porous safety net doesn’t yet exist—the agency still hasn’t implemented the draft proposal it released more than two years ago.[emphasis mine]

June 27, 2014, the FDA issued a final ‘food and nanotechnology’ guidance document (more on that later).

In the meantime, Dr. Andrew Maynard (Director of the University of Michigan’s Risk Science Center) strongly countered Philpott’s Mother Jones article with his own article published both on The Conversation (June 3, 2014) and on Nanowerk (June 4, 2014),

Recently the American publication Mother Jones published an article on the dangers of food laced with tiny metal oxide particles. The article, however, is laced with errors and misinformation.

The source material for the article came from a report by the environmental organisation Friends of the Earth, an online database of nanotechnology-based consumer products and a peer-reviewed paper published in 2012. However, the analysis of the information is flawed.

..

Bad journalism

The inventory Philpott cites is the Project on Emerging Nanotechnologies Consumer Products Inventory, which I helped establish in 2006 as a way better understand the increasing number of consumer products that were using engineered nanomaterials. It provides a useful but only qualitative sense of what was being used where, and relies on intermittent web searches and other sources of intelligence. The inventory was never meant to be comprehensive or authoritative.

Briefly, Andrew’s argument is that the FOE report (Way too little) which claims a tenfold increase since 2008 of food products with added nano titanium dioxide (and which Philpotts uses to build his case) is erroneous. In 2006, the inventory was voluntary and there was no oversight. At that time, eight food products had been added to the list. In 2013, the inventory was revived (Oct. 28, 2013 posting) and new information added from a 2012 academic paper. The products from the 2012 paper may have predated the 2006 inventory products, or not. There is no way to tell. Andrew notes this in his measured way,

As someone who works on the risks and benefits of nanotechnology, I can see how errors in translation crept into this story. The 2012 paper was addressing a legitimate concern that little is know about how much titanium dioxide is in the processed food chain. The Consumer Products Inventory provides important and unique insights into nanoparticles being used in products. Friends of the Earth have every right to ask what is known about the potential risks in what we’re eating. And reporters like Philpott have a professional obligation to highlight issues of concern and interest to their readers.

The problem with exaggerated and inflated claims is that FOE proves itself to be an unreliable source and Philpott’s failure to investigate adequately puts his own credibility into question. How can you trust either FOE’s materials or Philpott’s articles? The easiest way to begin rebuilding credibility is to admit one’s mistakes. To date, I have not seen any such attempts from FOE or Philpott.

Coming next: a research initiative into the health effects of nano and food and a research paper on nano in commercial drinks both of which help illustrate why there are concerns and why there is a reluctance to move too quickly.

Part two (the problem with research)

Part three (final guidance)

Natural and engineered nanoparticles in an Orion magazine podcast & in a NanoBosc machinima piece

The Jan. 16, 2013 Orion magazine podcast discussion (more about that later) regarding safety and engineered and natural nanoparticles arose from an article (worth reading) by Heather Millar in the magazine’s January/February 2013 issue, Pandora’s Boxes.

For anyone familiar with the term ‘Pandora’s box’, Millar’s and the magazine’s bias is made clear immediately, nanoparticles are small and threatening. From the Pandora’s box Wikipedia essay,

Today, the phrase “to open Pandora’s box” means to perform an action that may seem small or innocuous, but that turns out to have severe and far-reaching consequences. [emphases mine]

Millar’s article is well written and offers some excellent explanations. For example, there’s this from Pandora’s Boxes,

So chemistry and physics work differently if you’re a nanoparticle. You’re not as small as an atom or a molecule, but you’re also not even as big as a cell, so you’re definitely not of the macro world either. You exist in an undiscovered country somewhere between the molecular and the macroscopic. Here, the laws of the very small (quantum mechanics) merge quirkily with the laws of the very large (classical physics). Some say nanomaterials bring a third dimension to chemistry’s periodic table, because at the nano scale, long-established rules and groupings don’t necessarily hold up.

Then, she has some dodgier material,

Yet size seems to be a double-edged sword in the nanoverse. Because nanoparticles are so small, they can slip past the body’s various barriers: skin, the blood-brain barrier, the lining of the gut and airways. Once inside, these tiny particles can bind to many things. They seem to build up over time, especially in the brain. Some cause inflammation and cell damage. Preliminary research shows this can harm the organs of lab animals, though the results of some of these studies are a matter of debate.

Some published research has shown that inhaled nanoparticles actually become more toxic as they get smaller. Nano–titanium dioxide, one of the most commonly used nanoparticles (Pop-Tarts, sunblock), has been shown to damage DNA in animals and prematurely corrode metals. Carbon nanotubes seem to penetrate lungs even more deeply than asbestos. [emphases mine]

I think it’s worth ‘unpacking’ these two paragraphs, so here goes.  Slipping past the body’s barriers is a lot more difficult than Millar suggests in the first paragraph. My July 4, 2012 posting on breakthough research  where they penetrated the skin barrier includes this comment from me,

After all the concerns  about nanosunscreens and nanoparticles penetrating the skin raised by civil society groups, the Friends of the Earth in particular, it’s interesting to note that doctors and scientists consider penetration of the skin barrier to be extremely difficult. Of course, they seem to have solved [as of July 2012] that problem which means the chorus of concerns may rise to new heights.

I had a followup in my Oct.3, 2012 posting titled, Can nanoparticles pass through the skin or not?, suggesting there’s still a lot of confusion about this topic even within the scientific community.

Moving on to the other ‘breaches’. As I recall, there was a recent  (Autumn 2012?) nanomedicine research announcement that the blood-brain barrier was breached by nanoparticles. I haven’t yet encountered any mention of breaching the gut and I mention lungs in my next paragraph where I discuss carbon nanotubes.

As for that second paragraph, it’s an example of scaremongering. ‘Inhaled nanoparticles become more toxic as their size decreases’—ok. Why mention nano-titanium oxide in pop tarts and sunblocks, which are not inhaled, in the followup sentence? As for the reference to DNA damage and corroded metals further on, this is straight out of the Friends of the Earth literature which often cites research in a misleading fashion including those two pieces.  There is research supporting part of Millar’s statement about carbon nanotubes—provided they are long and multiwalled. In fact, as they get shorter, the resemblance to asbestos fibers in the lungs or elsewhere seems to disappear as per my Aug 22, 2012 posting and my Jan. 16, 2013 posting.

You don’t need to read the article before listening to the fascinating Jan. 16, 2013 Orion magazine podcast with Millar (reading portions of her article) and expert guests, Mark Wiesner from Duke University and director of their Center for Environmental Implications of Nano Technology (CEINT was first mentioned in my April 15, 2011 posting), Ronald Sandler from Northeastern University and author of Nanotechnology: The Social And Ethical Issues, and Jaydee Hanson, policy director for the International Center for Technology Assessment.

The discussion between Wiesner, Sandler, and Hanson about engineered and natural nanoparticles is why I’ve called the podcast fascinating. Hearing these experts ‘fence’ with each other highlights the complexities and subtleties inherent in discussions about emerging technologies (nano or other) and risk. Millar did not participate in that aspect of the conversation and I imagine that’s due to the fact that she has only been researching this area for six months while the other speakers all have several years worth experience individually and, I suspect, may have debated each other previously.

At the risk of enthusing too much about naturally occurring nanoparticles, I’m mentioning, again (my Feb. 1, 2013 posting), the recently published book by Nanowiki, Nanoparticles Before Nanotechnology, in the context of the stunning visual images used to illustrate the book. I commented previously about them and Victor Puntes of the Inorganic Nanoparticles Group at the Catalan Institute of Nanotechnology (ICN) and one of the creators of this imagery, kindly directed me to a machinima piece (derived from the NanoBosc Second Life community) which is the source for the imagery. Here it is,

NanoBosc from Per4mance MetaLES ..O.. on Vimeo.

Happy Weekend!