Tag Archives: nano silver

Ingesting nano silver: a double-blind study

American Biotech Labs (ABL) has released publicity about an intriguing study on ingesting nano silver. From the Apr. 23, 2013 news item on Nanowerk,

The study included 3-, 7-, and 14-day exposures to American Biotech Labs 10-ppm (15 ml/day) silver solution in a double-blind, placebo controlled, cross-over phase design. Healthy volunteer subjects (36, 12 per each time-exposure), underwent complete metabolic, blood and platelet count, urinalysis tests, sputum hyperresponsiveness and inflammation evaluation, physical examinations, vital sign measurements, and magnetic resonance imaging of the chest and abdomen at baseline and at the end of each phase.

… Keith Moeller, A Managing Director at ABL. “… As a prelim to the study, I volunteered to be checked for silver deposition in my body, after 15+ years of almost daily usage as a supplement to help boost my immune system. No silver residue was found anywhere in my system. We are always working hard to gain knowledge about silver. Because of this, we have now amassed a library of more than 300 major reports, studies and test series, all completed on our nano-silver technology by more than 60 different universities, government/military labs, and private institutions.”

In conclusion the report stated, “The In-vivo oral exposure of a commercial 10-ppm silver nano-particle solution over 3-, 7-, and 14-day exposures does not exhibit clinically important changes in metabolic, hematologic, urine, vital sign changes, physical findings or imaging changes visualized by MRI.” …

Oddly, I cannot find where this study was published nor does the news release, which originated the news item, appear on the company website (as of 4 pm PDT April 23, 2013).

As for the study itself, which researchers ran the study? Was a third party contracted to run it? How did they ensure the study was double-blind? I gather this was not a randomized study.

They state specifically there were no urine changes. If the subjects are eliminating the silver, shouldn’t they be able to see that in the urine? If the silver accumulates in the body, how much is too much? Might it not take longer than 14 days to reach a toxic or dangerous stage?

Moeller’s personal endorsement is not really convincing as one assumes that as managing director of the company he has much to gain by encouraging people to ingest nano silver (ABL sells it as a health supplement). The same holds true regarding this study, which seems to have been run by the company itself.

As it stands, the study seems a bit sketchy but hopefully more details will emerge.

Canada-US Regulatory Cooperation Council’s Nanotechnology Work Plan

Thanks for Lynn L. Bergeson for her Dec. 1, 2012 posting on the Nanotechnology Now website for the information about a Nov. 28, 2012 webinar that was held to discuss a Nanotechnology Work Plan developed by the joint Canada-US Regulatory Cooperation Council (or sometimes it’s called the US-Canada Regulatory Cooperation Council),

The RCC requested that industry provide more information on the commercial distribution of nanomaterials, as well as more transparency by claiming confidentiality of only that information absolutely critical to market advantage.

To compare risk assessment and risk management practices to highlight and identify best practices, data gaps, and differences between the two jurisdictions, the RCC sought nominations of a nanomaterial substance for a case study. Four nanomaterial substances were nominated: multiwall carbon nanotubes, nanocrystalline cellulose, nano silver, and titanium dioxide. The RCC has selected multiwall carbon nanotubes for the case study. The RCC intends to hold in March 2013 a workshop in Washington, D.C., to discuss information collected to date and approaches moving forward. In spring 2013, the RCC will hold one or two conference calls or webinars to discuss information gathered between countries and the path forward. Finally, in fall 2013, the RCC expects to hold a stakeholder consultation/workshop on results to date.

Here’s some background on the RCC. First announced in February 2011, the RCC had its first ‘stakeholder’ session (attended by approximately 240)  in January 2012 in Washington, DC. where a series of initiatives, including nanotechnology, were discussed (from the US International Trade Administration RCC Stakeholder Outreach webpage),

Agriculture and Food, Session A

  • Perimeter approach to plant protection

Agriculture and Food, Session B

  • Crop protection products

Agriculture and Food, Session C

  • Meat/poultry – equivalency
  • Meat/poultry – certification requirements
  • Meat cut nomenclature

Agriculture and Food, Session D

  • Veterinary drugs
  • Zoning for foreign animal disease

Agriculture and Food, Session E

  • Financial protection to produce sellers

Agriculture and Food, Session F

  • Food safety – common approach
  • Food safety – testing

Road Transport – Motor Vehicles

  • Existing motor vehicle safety standards
  • New motor vehicle safety standards

Air Transport

  • Unmanned aircraft

Transportation

  • Intelligent Transportation Systems

Transportation

  • Dangerous goods means of transportation

Marine Transport

  • Safety and security framework & arrangement for the St. Lawrence Seaway & Great Lakes System
  • Marine transportation security regulations
  • Recreational boat manufacturing standards
  • Standard for lifejackets

Rail Transport

  • Locomotive Emissions
  • Rail Safety Standards

Environment

  • Emission standards for light-duty vehicles

Personal Care Products & Pharmaceuticals

  • Electronic submission gateway
  • Over-the-counter products – common monographs
  • Good manufacturing practices

Occupational Safety Issues

  • Classification & labelling of workplace hazardous chemicals

Nanotechnology

  • Nanotechnology

Led jointly by senior officials from Canada and the United States, the purpose of the various technical review sessions was to seek expert advice and technical input from the approximately 240 stakeholders in attendance.

Since the Jan. 2012 meeting, a Nanotechnology Work Plan has been developed and that’s what was recently discussed at the Nov. 28, 2012 webinar. I did find more on a Canadian government website, Canada’s Economic Action Plan Nanotechnology Work Plan webpage,

Nanotechnology Work Plan

 Canada Leads: Karen Dodds, Assistant Deputy Minister, Science and Technology Branch, Environment Canada (EC)

Hilary Geller, Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch, Health Canada (HC)

U.S. Lead: Margaret Malanoski, Office of Information and Regulatory Affairs, Office of Management and Budget

Deliverable Outcome: Share information and develop common approaches, to the extent possible, on foundational regulatory elements, including criteria for determining characteristics of concern/no concern, information gathering, approaches to risk assessment and management, etc. Develop joint initiatives to align regulatory approaches in specific areas such that consistency exists for consumers and industry in Canada and the US.

Principles: Identification of common principles for the regulation of nanomaterials to help ensure consistency for industry and consumers in both countries

3-6 months:

Canada provides initial feedback on US “Policy Principles for the US Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials”.

6-12 months:

Countries complete an initial draft of shared principles for the regulation of nanomaterials.

12-18 months:

Update of draft principles informed from on-going stakeholder and expert consultations.

18th month:

Stakeholder consultation / workshop on results to date and future ongoing engagement.

Beyond 18 months:

Countries complete final draft of shared principles for the regulation of nanomaterials.

Workplan for Industrial Nanomaterials

Priority-Setting: Identify common criteria for determining characteristics of industrial nanomaterials of concern/no-concern

1-3 months:

  1. Define and finalize workplan (1st month)
  2. Develop mechanisms for stakeholder outreach and engagement (1st month)
  3. Conference call with relevant stakeholders to share and discuss workplan and call for Industry to volunteer nanomaterials for joint CAN/US review

3-6 months:

Share available scientific evidence regarding characteristics of industrial nanomaterials including that obtained from existing international fora (e.g. OECD Working Party on Manufactured Nanomaterials [Canada is a lead in the OECD Working Party on Manufactured Nanomaterials]).

8th month:

Stakeholder workshop to discuss information collected to date and approaches moving forward.

6-12 months:

Initiate an analysis of characteristics of select nanomaterials: similarities, differences, reasons for them.

Initiate discussions on approaches to consider for common definitions and terminology.

12th month:

Second conference call with relevant stakeholders to discuss non-CBI information gathered between the Countries and to discuss path forward in terms of development of reports and analyses.

12-18 months:

Develop draft criteria for determining characteristics of industrial nanomaterials of concern/no-concern.

15th month:

Third conference call with relevant stakeholders to discuss progress and to prepare for the upcoming stakeholder consultation/workshop.

Here’s information for the leads should you feel compelled to make contact,

Canada

(Lead) Karen Dodds, Assistant Deputy Minister, Science and Technology, Environment Canada ([email protected]; ph. 613- 819-934-6851)

Hilary Geller, Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch ([email protected]; ph. 613-946-6701)

United States

(Lead) Margaret Malanoski, Office of Management and Budget ([email protected])

I gather that the ‘stakeholders’ are business people, researchers, and policy analysts/makers as there doesn’t seem to be any mechanism for public consultation or education, for that matter.

Nanosilver history

According to Empa researchers, Bernd Nowack and Harald Krug, together with Murray Heights of the company HeiQ, silver at the nanoscale has a long history. From the Jan. 31,2011 news item on physorg.com,

Nanosilver is not a new discovery by nanotechnologists — it has been used in various products for over a hundred years, as is shown by a new Empa study. The antimicrobial effects of minute silver particles, which were then known as “colloidal silver,” were known from the earliest days of its use.

Their paper showing that nanosilver is not a 21st century discovery is being published in Environmental Science & Technology. From the news item,

Silver particles with diameters of seven to nine nm were mentioned as early as 1889. They were used in medications or as biocides to prevent the growth of bacteria on surfaces, for example in antibacterial water filters or in algaecides for swimming pools.

The nanoparticles were known as “colloidal silver” in those days, but what was meant was the same then as now – extremely small particles of silver. The only new aspect is the use today of the prefix “nano”. “However,” according to Bernd Nowack, “nano does not mean something new, and nor does it mean something that is harmful.” When “colloidal silver” became available on the market in large quantities in the 1920s it was the topic of numerous studies and subject to appropriate regulation by the authorities. [emphasis mine]

This suggests that there has been sufficient research on what we now call nano silver and its impact on the environment and on health. By contrast, the California Department of Toxic Substances Control (DTSC) had this to say in its recent call for information about analytical test methods for nanomaterials (from the Dec. 27, 2010 news item on Nanowerk),

Nano Silver

Nano silver is used increasingly in many consumer products. These include food contact materials (storage containers, cups, bowls and cutting boards), children’s toys and infant products, disinfectants, cosmetics, cleaning agents and machines, textiles, athletic apparel, dyes/paints, varnishes, polymers, and in medical products and applications. Given these diverse applications, nano silver is likely entering the environment. Several scientific studies describe potential adverse effects of nano silver on publicly owned treatment works (wastewater collection, treatment, and disposal systems).

Silver has been known historically as a potent antibacterial, antifungal, and antiviral agent. In recent years, silver is used as a biocide in solution, suspension, and in nano-particulate form. The strong antimicrobial activity is a major reason for the development of products that contain nano silver. Nano silver may also have applications in agricultural, vector, and urban pest control. However, little or no information about detecting and measuring the effect of nano silver in the environment exists. Recent published papers point out difficulties in quantifying the existence of nano particles in environmental and biological contexts, which presents challenges in estimating and assessing the hazards and risks of nano silver. [emphasis mine]

Nowack, one of the Empa researchers, provides evidence for his position in a commentary that was previously published in the journal Science (from the news item),

A commentary by Bernd Nowack in the scientific journal Science discusses the implications of the newest studies on nanosilver in sewage treatment plants. More than 90% remains bound in the sewage sludge in the form of silver sulfide, a substance which is extremely insoluble and orders of magnitude less poisonous than free silver ions. [emphasis mine] It apparently does not matter what the original form of the silver in the wastewater was, whether as metallic nanoparticles, as silver ions in solution or as precipitated insoluble silver salts.

“As far as the environmental effects are concerned, it seems that nanosilver in consumer goods is no different than other forms of silver and represents only a minor problem for eco-systems,” says Nowack. What is still to be clarified, however, is in what form the unbound silver is present in the treated water released from sewage works, and what happens to the silver sulfide in natural waters. Is this stable and unreactive or is it transformed into other forms of silver? [emphasis mine]

The two approaches are not directly contradictory but I do find the totality confusing. Which challenges about the hazards and risks of nano silver are the folks in California referring to? It seems they’re not familiar with the older research cited by Nowack or perhaps they know something Nowack and his colleagues do not. Meanwhile, Nowack’s Science commentary is reassuring but whoever wrote the news item was careful to point out that there is still some important work to be done before declaring nano silver to be a ‘safe’ substance.

I posted about the DTSC call for information, Feb. 7, 2011.

California’s call for information about nanomaterials

A little late but better than never, the US state of California has issued a call for information focused on analytical test methods, i.e., lab procedures for testing, nano silver, nano zero valent iron, nano titanium dioxide, nano zinc oxide, nano cerium oxide, and quantum dots. The deadline for a response is Dec. 21, 2011, one year from the date of the request. From the Dec. 27, 2010 news item on Nanowerk,

DTSC [Department of Toxic Substances Control] has conducted a search of known public sources for analytical test methods for these six nanomaterials. We have compiled our research in this bibliography. DTSC has also contacted and consulted with manufacturers, researchers, environmental laboratory experts, other governments, and stakeholders regarding analytical test methods for these nanomaterials in these matrices. We convened public workshops and symposia on nanotechnology and, in particular, these six nanomaterials.

From our research, consultations, and workshops, we have determined that little or no information on analytical test methods for these nanomaterials in the human body or the environment now exists. To better understand the behavior, fate and transport of the se six nanomaterials, appropriate analytical test methods are needed for manufacturers, for contract and reference laboratories, and for regulatory agencies.

You can get more information about the call from the DTSC site including a list of companies that received the ‘call for information’ letter.