Technology Law Source

Tag Archives: nanosilver

Danish EPA Releases Report on Environmental & Health Risks for Selected Nanoparticles

Denmark’s Environmental Protection Agency (DEPA)  recently released "Survey on basic knowledge about exposure and potential environmental and health risks for selected nanoparticles". The survey was written by Sonja Hagen Mikkelsen, Erik Hansen and Trine Boe Christensen of COWI A/S, Anders Baun and Steffen Foss Hansen of DTU Environment and Mona-Lise Binderup of DTU Food, all working under contract with DEPA.

Noting that "There is no single source of information that provides an overview of nanomaterials and products in Denmark or in the EU for that matter",

DEPA has therefore initiated this project to provide an overview of the existing knowledge about seven of the most common nanomaterials, their environmental and health properties, the use of those nanomaterials and the possibility of exposure of humans and the environment.

The seven nanomaterials selected as the focus of the survey are

1 – Titanium dioxide

2 – Cerium dioxide

3- Fullerenes (aka carbon balls or ‘buckeyballs")

4- Nanosilver

5- Zero-valent iron

6 – Silicium dioxide

7 – Nanoclay

These nanomaterials were selected based on

1- Application volums

2- Potential human exposure

3- Potential direct discharge into the environment

4 – Expected biological effect (human and/or environment), persistence or bioaccumultion

The authors of the survey developed "profiles" for the nanomaterials, focusing on " the general characteristics and manufacture of the nanomaterial, their current uses (mainly focused at consumer products) and hazard profiles (ecotoxicity and human toxicity) . . . . The profiles included sections discussing relevant exposures from consumer products and considerations regarding the …

EPA Requests Public Comment on Obtaining Information Regarding Nanomaterials in Pesticides

On June 17, 2011, the Environmental Protection Agency (EPA) published a notice in the Federal Register announcing that it was seeking "comment on several possible appraoches for obtaining information about what nanoscale materials are present in registered pesticide products. . .  . and its potential effects on humans or the environment. . . ."

Under one approach to collecting this information, EPA would use the authority granted to it by the Federal Insecticide, Fungicide,and Rodenticide Act  (FIFRA) to require applicants to "provide any factual information of which [the applicant] is aware regarding unreasonable adverse effects of the pesticide on man and the environment". If EPA adopts this approach, it would require the inclusion of "such information with applications for registrations of pesticides or pesiticide products containing ‘nanoscale materials’".

Under a different section of FIFRA, EPA would gather information using Data Call-In notices.

EPA is required to collect information regarding pesticides under section 3(a) of FIFRA. Using the information collected, EPA can then determine

1) the validity of the products claims

2) that labelling complies with FIFRA requirements

3) that the pesticide or pesticide product will not cause unreasonably adverse harm to humans or the environment.

EPA "believes that certain information concerning pesticide ingredients" – in this case, nanoscale materials, defined by EPA as (1) between 1 and 100 nanometers, (2) " exhibit unique and novel properties compared to larger particlesof the same material" and (3) has been manufactured or engineered at the nanoscale level to take advantage of those unique or novel properties …

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 …

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 …

Interesting Nano-Regulatory Developments

Inside U.S. Trade reports three interesting nano-regulatory developments: (i) the "EPA has signaled that it may soon decide to regulate nano-silver as a pesticide under " FIFRA; (ii) the "EPA may rule favorably on some points" raised in the 2008 citizen’s petition filed by 14 advocacy groups seeking more restrictive regulation of nanoscale silver; and (iii) Congresswoman Kathy DahlKemper (D-Pa) on the House Science and Technology Committee "is pursuing a Cosmetics Safety Bill that would require registration of cosmetics containing nanomaterials."…

Take two silver nanoparticles and call me in the morning

For decades after it was discovered, penicillin was used to combat bacteria and, eventually, almost every other disease, whether it was the appropriate treatment or not. Over time and over use of penicillin and its successor drugs, resistant strains of bacteria began to appear, to the point where, now, many strains of bacteria are almost completely drug resistant.

According to a recent article posted to the Australian Broadcasting Corporation (ABC) site, nanosilver might become the 21st century’s penicillin, being widely used in the medical field, but also in consumer products, such as combs, hair dryers,  men’s socks, and underwear.

Some of this overuse of nanosilver is probably due to companies simply following trends and wanting to appear cutting edge or it may be due to marketing efforts that fall into the "All New!" category. Other companies may be adding nanosilver as part of a genuine effort to improve their products and make them healthier, although how much healthier underwear is with nanosilver as opposed to underwear without is a debate probably best left to others.

While a total ban on the sale of products containing nanosilver, which groups such as Friends of the Earth propose is unlikely, (and frankly seems more like simplistic fear mongering than anything else), regulations on the amount of nanosilver in consumer products, based on the results of reputable studies and tests on the effects on humans and bacteria of prolonged exposure to nanosilver particles are needed.

Personally, I’d start by regulating the amount of silver …

Interim Report: Lukewarm Response to EPA’s Nanoscale Material Stewardship Program

Earlier today, the EPA published an interim status report regarding its Nanoscale Materials Stewardship Program.  A final report is expected in early 2010.

Nanoscale Materials Stewardship Program, Interim Report, January 2009, U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics.

At the outset, EPA notes that "[t]he findings and conclusions [of the] report should not be construed or interpreted to represent any Agency regulatory or statutory guidance or statement of official Agency policy."   Several companies submitting NMSP data should be relieved by this disclaimer, as EPA identified 18 nanoscale materials in NMSP submissions which may be considered new chemical substances under TSCA and subject to premanufacturing notice requirements.  Whether EPA takes any enforcement steps in this regard remains to be seen.

Getting to the highlights of the report, EPA concludes that the NMSP has (thus far) produce mixed results:

  • "In the aggregate, the NMSP has sufficiently advanced EPA’s knowledge and understanding to enable the Agency to take further steps towards evaluating and, where appropriate, mitigating potential risks to health and the environment."
  • "It appears that nearly two-thirds of the chemical substances from which commercially available nanoscale materials are based were not reported under the Basic Program."
  • "It appears that approximately 90% of the different nanoscale materials that are likely to be commercially available were not reported under the Basic Program."
  • "The low rate of engagement in the In-Depth Program suggests that most companies are not inclined to voluntarily test their nanoscale materials."

EPA’s overall conclusion is that:

"[T]he NMSP can be considered …

Nano-Silver EHS Backgrounder

With all of the interest in nanosilver generated by the recent EPA petition filed by the International Center for Technology Assessment, I thought I would post some background material on EHS issues surrounding silver.  A couple of disclaimers: the material is not comprehensive, and you might see parts of it again in "Nanotechnology Law and Policy" which should be published by Thomson-West legal publishers sometime in 2009 (if I can keep pace with the production schedule).

 …

Environmental Pollution from Nanosilver Socks?

A recent study by two Arizona State University researchers found that socks made of fabric incorporating nanoscale silver may potentially release that silver into wash-water.

T. Benn, et al., "Nanoparticle Silver Release into Water from Commercially Available Sock Fabrics," Environmental Science & Technology, Vol. 42, at 4133-4139 (2008).

Why put silver in your socks?  Because it is a well-known antimicrobial agent and microbes cause sock odor.  Kill the microbes, and your feet smell fresh.  At least that’s the marketing angle. 

 …

FIFRA and Fines

On March 5, 2008, the US EPA announced that it had fined the company IOGEAR for "for selling unregistered pesticides and making unproven claims about their effectiveness."  The fine, reached via settlement, was for $208,000, and IOGEAR has since removed its pesticide claims from the offending products.…

Nanosilver–In Case You Forgot

An article by Barnaby Feder in this morning’s New York Times reminds us of a question that, even a year later, has not been completely resolved.  Astute readers (and by "astute" I mean everyone who wasn’t under a rock) will remember the large discussion over the use of nanosilver as an anti-bacterial device, including the Samsung Silvercare washing machines.  Well, its back, or rather, never really left.…

EPA Finally Issues “Nanosilver” Notice

In response to the Samsung Washing Machine "nanosilver" controversy last year, EPA indicated it would issue a federal notice concerning how it intends to treat silver ion generators under FIFRA. Many urged EPA to use this opportunity to issue a broad proclamation that all products containing nanoscale silver would be required to be registered as pesticides under FIFRA. NanoLawReport believed EPA would issue a significantly narrower ruling.

On Monday, EPA finally published its promised federal notice requiring products that emit silver ions or other antimicrobial substances to be registered as pesticides under FIFRA. EPA was clear that the notice is not intended to regulate nanotechnology as a whole, nor has the Agency even received information suggesting that the Samsung washing machine in question uses nanotechnology. Whether EPA will require other products containing nanosilver to be registered under FIFRA is likely to be decided on a case-by-case basis.…

COUNTERPOINT: First EPA Regulation of Nanotechnology?

JCM: My reading is EPA’s new position on Samsung’s washing machine has little to do with the alleged "nanoness" of the silver ion particles released by the machine. Rather, EPA is focused on the claimed antimicrobial properties of the material. Whether or not the silver ions are truly "nano" is not determinative. Under EPA’s current thinking they would still be subject to FIFRA even if they were/are "full sized." Further, EPA has not even determined whether or not the washing machine truly uses nanotechnology, and has stated that such a finding is unnecessary for its ruling. Finally, EPA has made it clear that it evaluates all products on a case-by-case basis, and appears reluctant to make a categorical statement about all products containing nano-silver. Thus, while EPA’s upcoming notice to be published in the Federal Register will be of great interest, my guess is that it will not use the Samsung issue as a reason for treating nanomaterials any differently from the way it treats other microbial killing materials.…

LexBlog