Tag Archives: SCENIHR

Calling all scientists with a good command of English and expertise on medical devices containing nanomaterials

The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) needs experts because it has been asked by the European Commission to asses the use of nanomaterials in medical devices. From the Aug. 15, 2012 news item on Nanowerk,

The relevant SCENIHR working group has identified a need in the field of medical devices containing nanomaterials. In line with the Rules of procedure (pdf) of the Scientific Committees, a call for expression of interest for experts in this topic is launched.

To allow for a comprehensive assessment, experts in various scientific fields related to the safety of medical devices containing nanomaterials are encouraged to apply. Experience in risk assessment would be an advantage.

The deadline for submission for this call for experts is 1 October 2012 (kindly note that the registration to the database of experts with regard to the general work of the Scientific Committees is permanently open). Applicants are requested to indicate “SCENIHR: Medical devices Nano – call for experts” in the subject title of the message sent with their application.

The detailed description of the mandate for this request can be found here. It includes details such as this from the  introduction,

Today, a more widespread application of nanotechnologies and nanomaterials is imminent or already occurring in many areas, including health care. For nanomedicine, the three largest areas of application are diagnostics, drug delivery and regenerative medicine (ETP Nanomedicine 2009). In addition there are applications in surgery and thermotherapy (Vauthier et al. 2011). In the field of medical devices, the following cases of alleged use of nanomaterials have been identified by Notified Bodies:

– Carbon nanotubes in bone cements;

– Nanopaste hydroyapatite powder for bone void filling;

– Polymer setting material with nanoparticles in dental cements;

– Polycrystalline nanoceramics in dental restorative materials;

– Nanosilver or other nanomaterials used as coatings on implants and catheters;

– Nanosilver used as an antibacterial agent, for example in wound dressings (see also Wijnhoven et al. 2009).

Furthermore, there are reports on iron-oxide nanoparticles injected into tumour cells to be heated-up by radiation or an external magnetic field1. This type of use has not yet been clearly attributed to the legislation on medicines or to the legislation on medical devices. On one hand, the immediate effect is mechanical as the tumour cells burst. On the other hand, one might regard the legislation on medicines applicable as the burst cells are metabolised at a later point in time.

Although the general risk assessment requirements applicable for materials used in medical devices and previous scientific opinions on risk assessment of nanomaterials (see e.g. SCENIHR 2006, 2007 and 2009) are useful when assessing nanomaterials for medical applications, there is a need for further clarification in the risk assessment of such products. (p. 1)

The Terms of Reference include,

This evaluation shall take into account different categories of medical devices such as:

a.. Non-invasive medical devices, e.g. devices coming into contact with the

intact skin,

b. Invasive devices (surgical or not), e.g.:

o woundcare materials,

o implantable medical devices,

o dental and bone fillings and cements,

o injectable nanomaterials.

In this assessment, where relevant, the SCENIHR is invited to differentiate between free, fixed, and encapsulated nanomaterials. (p. 2)

The deadline listed in the mandate is March 2013. Presumably this is the deadline for the assessment itself while the deadline to apply as an expert is Oct. 10, 2012 according to the SCENIHR webpage for the August 2012 Call for Information on the Safety of Devices Containing Nanomaterials.

ETA Aug.15, 2012 11:20 am PDT: Given that I originally misspelled the word expertise in my headline for this post, maybe I need to check my own expertise … with English.

Toxicology convo heats up: OECD releases report on inhalation toxicity testing and Nature Nanotechnology publishes severe critique of silver toxicity overanalysis

This has to be one of the rawest reports I’ve seen and that’s not a criticism. The OECD (Organization for Economic Cooperation and Development) has released no. 35 in its Series on the Safety of Manufactured Nanomaterials titled, INHALATION TOXICITY TESTING: EXPERT MEETING ON POTENTIAL REVISIONS TO OECD TEST GUIDELINES AND GUIDANCE DOCUMENT.

This report is the outcome of a meeting which took place in fall 2011 according to the July 4, 2012 news item on Nanowerk,

The expert meeting on Inhalation Toxicity Testing for Nanomaterials was held on 19-20 October 2011 in The Hague, hosted by the Netherlands, with the aim of discussing the results of the OECD Sponsorship Programme (under the responsibility of SG3) on this specific topic and addressing issues relevant to inhalation toxicity. Fifty experts from the WPMN as well as the OECD Working Group of the National Coordinators for the Test Guidelines programme (WNT) participated in the meeting.

This is a partial list of recommendations from the report,

Recommendations raised by the speakers for the discussion

7. Various recommendations were raised by the speakers that served as points for discussion. These recommendations do not necessarily reflect a general agreement. …

• “Provide explicit guidance for the generation of aerosols (sample preparation) based on the exposure scenario”. Hans Muijser

• “Generation of a test atmosphere should have workplace characteristics, but should be adapted to adjust for rodent respirability”. Günter Oberdörster

• “A choice for a dry aerosol or a liquid aerosol should depend on the given test substance and planned test approach (hazard- or risk driven)”. Otto Creutzenberg

• “Aerosol characterization should include size distribution, mass, number and morphology of the material”. Günter Oberdörster

• “Mass concentration is not sufficient for comparison of nanomaterials of the same chemical composition”. Flemming Cassee

• “Dry powders will appear as agglomerate upon aerosolization, which needs to be addressed in the sample preparation guidelines”. Flemming Cassee

• “Dissolution behaviour of the test substance should be assessed in physiological fluids mimicking various lung-specific pH ambiences (neutral, acid)”. Otto Creutzenberg

• “Data analysis should include interpretation of aerosol characteristics, NOAEL, risk assessment implications, mode of action and a strategy for dosimetric extrapolation to humans. The inclusion of biokinetic data is important”. Günter Oberdörster

• “Include biokinetics in the guidance, since different distribution patterns in the whole organism are likely dependent on physicochemical characteristics of nanoparticle aerosols and the dose at the target site will therefore be different. This will allow the assessment of accumulation of nanomaterials in the body at low exposure levels and long-term exposure. A way to perform it is by radiolabelled materials, chemical elemental analysis to determine organ concentrations and transmission electron microscopy”. Wolfgang Kreyling. Others who have suggested inclusion of biokinetics or recognized the importance were Otto Creutzenberg, Frieke Kuper, Günter Oberdörster and David Warheit. (p. 13)

You actually see who made the recommendations! Speakers discussed carbon nanotubes, titanium dioxide, cerium oxide, zinc oxide and more, all of which you can read about in summary form in this 38 pp. report.

Meanwhile, Nature Nanotechnology has published an incendiary commentary about nanosilver and the latest request by the European Commission for another study.  Michael Berger has devoted a July 4, 2012 Nanowerk Spotlight article to the commentary,

A commentary by Steffen Foss Hansen and Anders Baun in this week’s Nature Nanotechnology (“When enough is enough”  [behind a paywall]) pointedly asks “when will governments and regulatory agencies stop asking for more reports and reviews, and start taking regulatory action?”

Hansen and Baun, both from the Technical University of Denmark’s Department of Environmental Engineering, take issue with yet another scientific opinion on nanosilver that has been requested by the European Commission in late 2011: “SCENIHR – Request for a scientific opinion on Nanosilver: safety, health and environmental effects and role in antimicrobial resistance” (pdf). Specifically, the EC wants SCENIHR to answer four questions under the general heading of ‘Nanosilver: safety, health and environmental effects, and role in antimicrobial resistance’.

“Most of these questions – and possibly all of them – have already been addressed by no less than 18 review articles in scientific journals, the oldest dating back to 2008, plus at least seven more reviews and reports commissioned and/or funded by governments and other organizations” Hansen tells Nanowerk. “Many of these reviews and reports go through the same literature, cover the same ground and identify many of the same data gaps and research needs.”

Here’s a prediction from Hansen and Baun as to what will be in the next report due in 2013  (from the Nature Nanotechnology commentary When enough is enough in 7, 409–411 (2012) published online  July 1, 2012 [Note: I have removed links and footnotes]),

… we predict that the SCENIHR’s upcoming review will consist of five main sections summarizing: the properties and uses of nanosilver; human and environmental toxicity; microbial resistance; risk assessment; and research needs. We also predict that the SCENIHR’s report will say something along the following lines: “Nanosilver is reportedly one of the most widely used nanomaterials in consumer products today but the scale of production and use is unknown. The antibacterial properties of nanosilver are exploited in a very diverse set of products and applications including dietary supplements, personal care products, powdered colours, textile, paper, kitchenware and food storage.” And like many previous reviews and reports, the new report is likely to cite the Consumer Product Inventory maintained by the Project on Emerging Nanotechnologies.

We acknowledge that answering the question of how to regulate the use of nanosilver is not easy given the different views of the different stakeholders in this debate and the complex regulatory landscape associated with the many applications of nanosilver. …

Arguably, we all want that the pros and cons of regulatory policy options be based on the best available science while taking broader socio-economical and ethical aspects into consideration before deciding on the appropriate regulatory measures concerning human and environmental exposure to nanosilver. Although it is common for independent scientific experts to be commissioned to gather, analyse and review the available scientific information, and to provide recommendations on how to address a given risk, we do not see the need for further reviews. It is time for the European Commission to decide on the regulatory measures that are appropriate for nanosilver. These measures should then be implemented wholeheartedly and their effectiveness monitored.

I predict this commentary will provoke some interesting responses and I will try to add the ones I can find to this posting as they become available.

ETA July 6, 2012: Dexter Johnson weighed in with his July 5, 2012 posting (Note: I have removed a link),

What may make the matter even worse is that we may already have a pretty substantial framework—in the US, at least—on which to base nanosilver regulations, which dates back to the 1950s. It concerned what was called at the time collodial silver, which is essentially what today is called nanosilver.

But getting back to current stagnant state of affairs, it’s hard to know exactly what’s causing the paralysis. It could be concern over implementing regulations in a depressed economy, or just a fear of taking a position. But in both these instances, the lack of action is making the situation worse. …