EPA Releases Draft Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray

The EPA recently released a draft of its "Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray" which you can download here.  The document is 323 pages long and has 6 chapters: (i) Introduction; (ii) Introduction to Silver and Nanoscale Silver; (iii) Life-Cycle Stages; (iv) Fate and Transport in Environmental Media; (v) Exposure, Uptake, and Dose; and (vi) Characterization of Effects.

In two chapters most pertinent to our readers, the document discusses the possible EHS ramifications of the manufacturing and use of nanoscale silver disinfectants over a wide-range of issues.  Regarding Life-Cycle Stages, the document covers five primary product stages: feedstocks; manufacturing; distribution and storage; use; and disposal.  Similarly, regarding fate and transport in the environment, the document discusses air, terrestrial, and aquatic systems and factors that effect transport and fate in each media.

Overall , the document appears to mirror the approach used in EPA's prior draft case study on nanoscale titanium dioxide used in drinking water systems and in sunscreens which was published in 2009. 

Written comments on the draft are due to EPA by September 27, 2010.

 

European Parliament Members Vote for Ban on Nanomaterials, Including Nanosilver and Carbon Nanotubes

The Members of the European Union’s (“EU”) Environment Committee (“MEPs”) recently voted in favor of proposed amendments to the EU’s Restriction of Hazardous Substances Directive, first passed in 2002, banning the use of nanosilver and long multi-walled carbon nanotubes in electrical and electronic products. The legislators also approved language requiring that any electrical or electronic materials containing nanomaterials should be labeled as such and that manufacturers who use nanomaterials would be required to provide the European Commission with safety data on any materials used. Commentators have noted that the MEPs’ definition of nanomaterials is unclear and the current interpretation could require labeling for every electronic product, such as every transistor in a computer chip. A vote on the proposal is expected in October.

EPA Set to Rule on FIFRA Nanosilver Petition in June

Inside EPA reports today that a "senior policy adviser for EPA's Office of Pesticide Programs, said EPA would issue in June a long-awaited response to a 2008 activist petition asking the agency to regulate nanoscale silver under FIFRA."  The article also mentions that EPA intends to define nanoscale ingredients for FIFRA purposes as "an ingredient that contains particles that have been intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers."

IEEE Blogger Comments on Nanosilver Article

Earlier today, an IEEE blogger commented on a nanosilver article we previously re-published on this cite.   The original article was written by the Silver Nanotechnology Working Group and was first published on the University of Massachusetts, Amherst's InterNano website (where I am Contibuting Editor for Environmental, Health and Safety and Regulation). 

Dexter Johnson comments on the Nanoclast blog of IEEE's Spectrum website:

"In what must come as a blow to NGOs around the world it turns out that the material that has fueled much of their indignation about nanotechnology, nanosilver, has not only been 'rationally manufactured, regulated, and used commercially for over a century with no significant adverse environmental, health, and safety effects', but also the EPA has specifically been looking at nanosilver as far back as the 1950s."

Working Group Makes Important Contribution to EPA's Scientific Advisory Panel on Nanosilver

This article was contributed by Dr. Rosalinda Volpe, Executive Director, Silver Nanotechnology Working Group (SNWG) and originally appeared on the National Nanomanufacturing Network's InterNano website earlier today.  It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

On November 3 – 6, 2009 the US Environmental Protection Agency (EPA) held a Scientific Advisory Panel (SAP) meeting in Arlington, Virginia to discuss the “Evaluation of Hazard and Exposure Associated with Nanosilver and Other Nanometal Oxide Pesticide Products.”[1] The meeting was well attended. Over seventy-five people from industry, regulatory, public interest, and academic sectors attended the meeting over three days. EPA received presentations and comments from the SAP panel members during the course of the meeting, as well as six presentations during the Public Comment period, and also received over 560 written comments which can be found on EPA’s website.

One group—The Silver Nanotechnology Working Group (SNWG)[2] —made a detailed presentation[3] to EPA supporting a fundamental regulatory consideration previously overlooked by many in attendance: nanosilver has been rationally manufactured, regulated, and used commercially for over a century with no significant adverse environmental, health, and safety effects. SNWG explained that nanosilver—often called by other names such as "colloidal silver" or "millimicron silver"—has been used in a wide range of consumer applications such as swimming pool treatments and drinking water filters with an established record under FIFRA of regulated and safe use dating as far back as the 1950’s. Thus, SNWG believes that nanosilver is not a “new” material requiring some type of special regulation and EPA needs to look beyond general conceptions of nano terminology and consider the broader established regulatory record of nanoscale silver products within the Agency. Simply put, SNWG believes that calls for treatment of nanosilver as a new material requiring development of expensive new test regimes and discriminatory regulation are difficult to justify.

Moreover, SNWG explained at the meeting that a detailed look at the history of silver within EPA shows that the toxicological studies that form the center of EPA’s existing general hazard limits for silver are derived from historical data from nanoscale silver materials and not conventional (bulk) silver as is often mistakenly assumed. For example, SNWG’s careful examination of EPA’s public registration database[4] for silver over a period of 6 decades revealed:

  • The very first registered silver product was a colloidal nanosilver algaecide product that has been safely used by millions of consumers for over 50 years (registered since 1954).
  • Every EPA silver registration between 1970 and 1990 was either a colloidal nanosilver or nanosilver-composite product.
  • The very first NON-nanosilver product registered by EPA was not registered until 1994.
  • An overall analysis reveals that today over 50% of all EPA registered silver products are in fact based on nanoscale silver.

Based on its analysis, SNWG took the formal position that EPA has a range of existing regulatory structures that have successfully addressed silver materials across the size spectrum for over 5 decades. Additionally, EPA has not any incidents of significance on the Agency’s formal incident reporting database (EPA OPP IDS) – indicating that thorough monitoring of real-life use supports the safety of these products.

The SWNG congratulated EPA for its record of successful monitoring and risk management for these materials despite different terminologies being used throughout this time period. Indeed, SNWG pointed out that with nanosilver there is perhaps more historical data and evidence of safe use than for many other regulatory materials, and the EPA has the opportunity to assess nanosilver products with confidence given this long history of safe use under existing EPA regulatons.

The SNWG is hopeful that the EPA and the other meeting attendees will examine SNWG’s position and supporting information in more detail to confirm that nanosilver has been successfully regulated for decades. If sufficient consideration is given, SNWG believes that EPA will conclude that there is no need to “fix” a regulatory process that is not “broken,” but has worked exceedingly well for decades in the case of nanosilver.

References

1.  EPA Scientific Advisory Panel meeting, Arlington VA (November 3 - 6, 2009).

2.  SNWG is an industry effort intended to foster the collection of data on silver nanotechnology in order to advance the science and public understanding of the beneficial uses of silver nanoparticles in a wide-range of consumer and industrial products.

3.  SNWG “Evaluation of Hazard and Exposure Associated with Nanosilver and Other Nanometal Oxide Pesticide Products”, Presentation to Scientific Advisory Panel (November 4th, 2009).

4.  NPIRS Public.

Another Nano-Silver Sock Study

We have previously reported on a study by Arizona State researchers looking into the potential release of nanosilver particles from odor-killing socks during theoretical wash cycles.  A new study from Switzerland examines the issue in further detail.

L. Geranio, et al., "The Behavior of Silver Nanotextiles during Washing," Environ. Sci. Technol. (Sept. 2009).

Three authors from the Swiss Federal Laboratories for Materials Testing and Research conducted the study with the aim of determining "the amount and the form of Ag released during washing from nine fabrics with different ways of silver incorporation into or onto the fibers."  The study generally found that when washed at low pH levels, there was little dissolution of nanoparticles from the textiles being tested.  However, the researchers theorized that the use of bleach "can greatly accelerate the dissolution of Ag."  The percentage of total silver emitted during one wash cycle for the fabrics varied between 1% and 45%.  Almost 75% of the silver released was greater than 450 nm in diameter. 


 

Nanosilver and the FIFRA Scientific Advisory Panel Public Meeting

Earlier today, the Federal Register carried a notice regarding the 4 day consultation meeting of the FIFRA Scientific Advisory Panel concerning the assessment of hazard and exposure associated with nanosilver and other nanometals in pesticides, previously announced in the FR for September 16, 2009 and discussed previously here. Today's announcement notes a change in the time for the meetings. The consultation meeting will take place from 1:30-5PM on Nov. 3, 2009. Wednesday Nov. 5 - Friday, Nov. 6, 2009, will still take place from 8:30AM - 5PM. For further information on submitting filings, please see the notice.

 

EPA Scientific Advisory Panel to Discuss Nanoscale Silver at Public Meeting

A much valued contributor from CyberRegs provided us with the following information from the Federal Register that may be of interest to readers:

There will be a 4-day consultation meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review a set of scientific issues related to the assessment of hazard and exposure associated with nanosilver and other nanometal pesticide products.

DATES: The consultation meeting will be held on November 3 - 6, 2009, from approximately 8:30 a.m. to 5:00 p.m. The consultation meeting will be held at the Environmental Protection Agency, Conference Center, Lobby Level, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA 22202.

Comments. The Agency encourages that written comments be submitted by October 20, 2009 and requests for oral comments be submitted by October 27, 2009. Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

FOR FURTHER INFORMATION CONTACT: Joseph E. Bailey, DFO, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-2045; fax number: (202) 564-8382; e-mail address:
bailey.joseph@epa.gov.

 

 

New Edition of Nanotechnology Law Report

Here is the Summer 2009 edition of Nanotechnology Law Report.  The newsletter contains the below-listed articles (and more):

  • EPA Issues Significant New Use Rules for Carbon Nanotubes
  • Are Nanoparticles Released by Cutting or Compounding Nano-Composites?
  • Annual Nano TiO2 Production Estimated at 44,000 Metric Tons
  • Are Nano Consumer Products Headed Underground?
  • Oversight of Next Generation Nanotechnology
  • Regulating Nanotechnologies
  • More Interesting Nano-Regulatory Developments
  • Nano Tug of War
  • Pumpkins & Nanoparticles
  • Green Nano
  • NanoBiotech 2009
  • Take two silver nanoparticles and call me in the morning
  • International Approaches to the Regulatory Governance of Nanotechnology
  • ETUC Resolution on Nanotechnologies and Nanomaterials
  • Private Spending on Nano Exceeds Government Spending
  • EMERGNANO Released

Nano & Biocidal Silver: Extreme Germ Killers Present a Growing Threat to Public Health

Friends of the Earth (FOE) released the above entitled report, written by Dr. Rye Senten and Ian Illuminato, in June of this year. As with their earlier report on nanotechnology and farming (discussed here ), Nano & Biocidal Silver comes to three conclusions:

1 Nanotechnology and its products, in this case, nanosilver, will destroy the environment and cause the death of humanity

2 Nanotechnology is the result of a conspiracy between government and big business against consumers

3 The only solution is an immediate moratorium on nano-anything.

This report, as with its earlier one, does raise some legitimate concerns:

The disposal of biocidal silver products into waste water raises a number of concerns as the resulting sewage sludge may be used on agricultural soils, disposed as solid waste into landfills or be incinerated. Biocidal silver may also disrupt the functioning of key soil microbial communities.

But for every legitimate concern raised or useful suggestion, such as changing la belling requirements so that products containing nanosilver or other nanoproducts have them clearly listed on the packaging so that consumers are aware of what they're buying and can either purchase the product or one that doesn't contain any nano-products, there are suggestions that the use of nanosilver in medicine or consumer products is the result of digital photography:

From an economic point of view, with the demise of the photographic industry, silver producers were desperately needing to find new markets for silver. It appears this quest has been successful, industrial and electronic applications of silver, along with the ever increasing uses for silver biocides, have easily made up for this loss.

In other sections of the report the discussion of the use of nanosilver gives way to a condemnation of capitalism and industrial production, suggesting that corporations and governments are allied in a conspiracy against workers and consumers:

In many respects, the increasing use of nanosilver is a typical example of what Gould (2005) has called "the technological treadmill of production". The purpose of this treadmill is growth in the form of an increased corporate profitability at the expense of workers and the environment and it "depends directly on technological innovation to replace human labor with capital and to increase the capacity for the transformation of natural resources into commodities". . . . the treadmill increases profits and environmental threats while reducing the generation of social benefits (employment, wages, etc) "ensuring constant increases in social and environmental inequality". . . . A hallmark of the technology treadmill of production is that, despite claims to the contrary, the economic benefits of any form of nanotechnology will accrue to corporations and governments, while the economic costs will be born by the citizens and the environment.

In other sections, there are discussions which are just downright bizarre:

One of the unanswered questions is, 'why has silver suddenly become so popular?'. By extension, we must also ask, 'why are we so afraid of bacteria and dirt?'. Tomes (2009) points out that our current obsession with germs has parallels with a similar period of intense anxiety about disease causing agents between 1900 and 1940. It is her contention that this 'new' fear of germs reflects our anxieties about globalization, the environment, suspicions of governmental authority, and distrust of expert knowledge.

I doubt that anyone pouring hydrogen peroxide over a cut is doing it because they don't trust the government or experts or because they're worried about globalization.

Throughout the report, the authors assert that exposure to nanosilver is dangerous and could lead to the nervous system being adversely affected, but then  almost immediately cast doubt on their own assertions:

There is a risk to consumers if nanosilver particles could migrate from food contacts materials into food or drink and could be subsequently ingested. . . . preliminary work by Chaudhry et al (2008) does indeed indicate that some nanosilver particle migrate into food, but perhaps at an insignificant level.

. . . While readily absorbed into the human body through food and other means, silver is not an acknowledged trace element, but appears not to cause any major diseases.

. . . Clearly workers in industries using silver or increasingly nanosilver are most vulnerable to occupational exposure and strict occupational health and safety standards must be implemented and their compliance subsequently monitored.

It is presently no known how to determine if the human central nervous system is vulnerable to silver toxicity at at what dose. While there is some evidence that silver may cross the blood brain barrier . . . the evidence is inconclusive and silver deposits do not appear to result in detectable neurological damage.

The authors also state that

FDA's failure to take concurrent oversight action demonstrates the agency's lack of urgency in protecting the public from the potential health and environmental risks of nanotechnology.

This despite earlier stating that nanosilver and other nanoparticles have not so far been connected to any illness, organ failure or any other negative result.

The authors, at the end of the report, make a list of demands on governments:

Friends of the Earth calls for an immediate moratorium on the commercial release of products that contain manufactured nanosilver until nanotechnology specific regulation is introduced to protect the public, workers and the environment from their risks and until the public is involved in decision making.

Friends of the Earth United States and Australia have furthermore called for the recall of Samsung;s silver appliance range (washing machine, vacuum cleaner, refrigerator, air conditioner, etc). . . . We believe similar measures should be enacted for clothing and other products that contain nanosilver

While calling for involving the public in creating new regulations, FOE proposes no method of doing so. This seems rather irresponsible and cynical at best. How should the public be involved- plebiscite? Mass meeting? FOE seems to expect that it will happen spontaneously. The public can already be involved in creating new regulations. On both the state and federal levels, proposed regulations are published in the Federal Register and its state level equivalents; the prosed regulations and rules contain contact information and how to submit comments for or against the proposed regulations, either via e-mail or the old fashioned way, a letter. Citizens can also contact their elected representatives and express their opinion.

While the report does raise point that are areas of concern that should be further examined and while it does make one or two useful suggestions, on balance, the report fails. This is not by any means an objective report and ultimately it collapses under the weight of  the socio-economic-political baggage that FOE has placed upon it.