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 related risk."

The first two chapters of the survey, "Introduction" and "Nanomaterials Survey" discuss the nature of the nanomaterials, their use in industries, general availability of products incorporating the nanomaterials and brief summaries of earlier studies. Chapters 3-9 focus on the individual nanomaterials selected for this survey, discussing the general characteristics of a specific nanomaterial, how it is manufactured, which consumer products available in Denmark, either via a website or a bricks and mortor shop, review of toxicity studies, possible scenarios where humans and the environment might be exposed to the nanomaterials, ranging from disposal of products containing nanomaterials in landfills to the use of nanomaterial ensconced cosmetics, such as sunscreens containing titanium dioxide, and brief discussions of "risk profiles" for the selected nanomaterials. Summary sheets are found at the end of the chapters.

Chapter 10, "Exposure and risk potential", raises a point that critics of this survey will note:

. . . the range of toxicological and ecotoxicological studies available is not sufficient to allow firm conclusions with regard to the toxicity of the nanoparticles compared to their bulk counterparts. . . (emphasis added)

As one might then expect, the authors of this survey come to the conclusion that, in order to answer the questions regarding nanomaterials and risk more information and research is needed.

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 - have not been routinely provided to EPA, complicating the agency's attempts to fulfill its legal obligations.

In determining whether an ingredient meets this description, EPA
may review particle size data and, among other things, the
manufacturing process to determine whether it employs processes
specifically to create or enhance the proportion of nanoscale materials
in the product, as compared with other processes used to produce
similar products. The Agency generally expects that these ingredients
may comprise, but are not limited to, metal-based (e.g., silver) and
carbon-based (e.g., carbon nanotubes) nanoscale materials. . . EPA would
review information provided by a registrant or applicant concerning the
composition of the pesticide product and to provide an Agency view on
whether the product did (or did not) contain a nanoscale material for
purposes of this policy.

 

Noting that ". . . there is a growing body of scientiific evidence showing that differences can exist between nanoscale material[s] and their non-nanoscale counterpoint[s]. . . EPA sees the emergence of nanoscale materials as offering . . .potential benefits for society in many different fields, including pest control products". Among these potential benefits are :

1) creation of more effective and efficient targeting of pesticide products

2) use of smaller quantities of pesticide products, reducing the amount of pesticides circulating in the environment

3) reducing the frequency of usage of these products.

All of these benefits would lead to "improved human and environmental safety and could lower pest control costs. . .. EPA seeks to encourage innovative work in developing nanoscale materials to realize these benefits".

But while EPA may be encouraging innovative work to realize those benefits, it is also aware that

the small size . . . or the unique or enhanced properties of nanoscale materials may, under specific conditions, pose new or increased hazards to humans and the environment. . . . It is important to empasize that  . . any individual type of nanoscale material may
not display all or even any of the characteristics observed and
reported for other nanoscale materials. In other words, some nanoscale
materials may have properties which, for purposes of assessing the risk
of a pesticide, are essentially identical to larger sized materials (or
particles) of the same substance. Furthermore, nanoscale materials may
also have properties that make them less risky, or more beneficial in
some other way, than larger sized materials (or particles) of the same
substance. So, it appears increasingly likely that there are few, if
any, universal ``nanoscale'' effects, and the distinctive effects seen
at nanoscale are specific to the properties of each material type under
specific exposure scenarios. Thus, EPA does not regard the fact that an
ingredient meets our description of a nanoscale material as evidence
that a pesticide containing the ingredient would cause unreasonable
adverse effects on the environment and thus would no longer meet the
statutory standards for registration. Rather, the presence of a
nanoscale material in a pesticide is grounds for EPA to consider the
possible need for data to characterize the potential of the ingredient
to pose risks. However, the registration status of a product would not
change merely as a result of providing information to EPA about the
presence of a previously-unreported nanoscale material. If, based on a
science based assessment of the risks of the specific pesticide
ingredients involved, EPA were to determine that the pesticide no
longer met the criteria for registration, or that some change was
needed in the conditions of use, EPA would conduct a separate action to
notify the manufacturer of that determination, consistent with current
FIFRA regulations.
    Finally, scientifically speaking, there currently is no bright line
with respect to a size below (or above) which nanoscale materials do
(or do not) exhibit properties that might be of interest in assessing
whether a pesticide product has the potential to cause unreasonable
adverse effects on the environment. Therefore, the precise size range
in nanometers addressed by the policies proposed in this document might
be revised in the future as new information becomes available.

EPA believes that any of the
following types of information are relevant to assessing the potential
of a pesticide to cause unreasonable adverse effects on the
environment:
    Any information concerning what nanoscale materials are
present in pesticides, whether as an active ingredient or as an inert
ingredient;
    For any pesticide product that contains nanoscale
material, whether active or inert, any existing information that
characterizes the size and size distribution of the nanoscale material
as measured in nanometers;
    For any pesticide product that contains nanoscale
materials, whether active or inert, any existing information that
describes the manufacturing process used to produce the nanoscale
material in whatever size range it is produced;
    For any pesticide product that contains nanoscale
materials, whether active or inert, and that also is or will be used
for an end-use formulation that contain(s) a composite (e.g., the
active ingredient is a matrix complex comprised of the nanoscale
material(s) in combination with a carrier, such as silica or sulfur),
any existing information that characterizes the size and size
distribution of the composite; and
    For any pesticide product that contains nanoscale
materials, whether active or inert, any existing information that shows
adverse effects at any level of exposure to the nanoscale material on
humans or nontarget species, and/or that shows the levels or nature
(e.g. routes, frequency, or life stage) of potential human and environmental exposure.
. . . . the foregoing is not intended to be an exclusive list.
To the extent that a registrant has a pesticide product that contains a
nanoscale material, and in addition has any other existing information
not captured in the previous list that pertains to, concerns, or
otherwise relates to the nanoscale material and has the potential to
raise questions about the continued registration of a product or the
appropriate terms and conditions of a product registration, EPA is also
considering whether this too should be submitted to the Agency.
 

The main purpose of this notice was to solicit comments regarding how EPA will collect information regarding nanoscale materials in pesticides or pesticide products. As stated above, EPA is considering two methods.

The first is to require that information submitted by registerants of pesticides under 6(a)(2) of FIFRA include information about nanoscale materials.

Noting that some stakeholders have objected to this method of collecting information as (1) potentially stigmatizing nanoscale materials as causing "adverse effects" on humans and/or the environment and (2) "overly burdensome", EPA notes that

1) " It is . . .EPA's position that . . .filing an additional report . . .doesnot stigmatize pesticides and wouldnot stigmatize any nanomaterials in pesticides since filing such reports is quite common."

2) . . . only registrants who know that their products contain nanoscale
materials would be required to report to EPA. Further, they would be
required to report only the information they know about. Section
6(a)(2) does not require a registrant to generate new data or to seek
out additional information. Further, registrants and applicants whose
products do not contain nanoscale materials (or who do not know that
their products contain nanoscale materials) would have no reporting
obligation under FIFRA section 6(a)(2).

Alternatively, EPA could gather the information it needs by using the authority granted to it under section 3(c)(2)(B) of FIFRA to issue Data-Call In Notices and to require the inclusion of this information "with any application for registration of a pesticide product that contains a nanoscale material". The use of DCIs would prove burdensome for both EPA and registrants, requiring the former to have to create new administrative procedures to monitor the intake and processing of reports, and for the latter, who would have to generate data about it's products that it didn't have

Under either the 6(a)(2) or the 3(c)(2)(B) approach, DCIs targeted
to individual pesticide products that contain specific nanoscale
materials would likely be used in the future to collect more specific
information or data about particular products. EPA would consider doing
so on a case-by-case basis and would tailor any request for information
accordingly.

 

Some stakeholders have suggested that EPA simply propose a new regulation to require the disclosure of what nanoscale materials are present in a pesticide as part of the application for registration of a pesticide. EPA, while not considering proposing such a regulation at this time, is also seeking comment on that appraoch.

EPA is also considering a change in policy in how it classifies applications for registration of pesticides with nanoscale materials

. . . . EPA is thus proposing that it not make
the requisite findings absent specific information on the nanoscale
material included in a pesticide product when the application relies on
a comparison to a currently registered pesticide product containing
either a non-nanoscale version of the same ingredient or another
nanoscale version of the ingredient that has different characteristics. 
. . . .  EPA would initially classify any application for
registration of a pesticide product containing an active or inert
ingredient that is a nanoscale material as an application for a ``new''
active or inert ingredient, even when another registered pesticide
product contains a non-nanoscale form of the ingredient or a nanoscale
form of the ingredient with different size dimensions or other
properties. This initial presumption, however, could be rebutted on a
case-by-case basis through the submission of, among other
possibilities, bridging data or other information demonstrating to
EPA's satisfaction that the nanoscale material's properties, which are
relevant to assessing the potential risks to human health and the
environment, are substantially similar to the properties of the
already-registered non-nanoscale or already-registered nanoscale form
of the material, or that the nanoscale material differs only in ways
that do not significantly increase the risk of unreasonable adverse
effects on the environment, and that approving the registration in the
manner proposed would not significantly increase the risk of any
unreasonable adverse effect on the environment.
    If an applicant could make this showing to EPA's satisfaction, then
the application would be processed as a ``me-too'' application within
the timeframes prescribed for such applications.

EPA concludes the notice by presenting several questions for respondents to consider:

EPA  specifically invites comments on the following issues:
    1. In view of the Agency's goal of identifying what nanoscale
materials are in products so that EPA can determine whether it needs
additional data to evaluate the products' safety under FIFRA, should
EPA change the description of a ``nanoscale material''? For example,
should the size range remain ``between approximately 1 and 100 nm in
one dimension''? Are there other characteristics that EPA should
consider, e.g., morphology, including shape and crystal structure;
surface chemistry and reactivity; specific surface area, charge;
solubility; conductive, magnetic, and optical properties?
    2. Should the reporting requirement apply only to nanoscale
material that is ``intentionally produced to have at least one
dimension that measures between approximately 1 and 100 nanometers,''
or should it also apply to naturally occurring materials? Why?
    3. Is the meaning of ``intentionally produced'' sufficiently clear?
If not, in what circumstances would the term be unclear and how might
it be clarified? Would offering a consultation procedure--by which a
registrant or applicant describes to EPA the production process that
results in the presence of a material in the nanoscale size range, and
EPA responds with a determination regarding whether reporting is
required--be an acceptable approach to providing clarity?
    4. Should the reporting requirement apply to ingredients in
pesticides that contain any amount of a nanoscale material, or should
the requirement apply only if an ingredient contains more than a
specified percentage (e.g., 10%) of nanoscale material? If the latter,
what should the specified percentage be and why?
    5. How should the reporting requirement apply to a pesticide
manufacturer who purchases ingredients that may contain nanoscale
material?
    6. Are there ways in which the description of ``nanoscale
materials'' can be refined and clarified, including ways in which
agglomeration and aggregation could be considered as well as
suggestions for ways in which more subjective criteria, such as
``unique or novel properties'' can be incorporated into the screening
criteria?
    7. Is EPA's description of ``nanoscale material'' inconsistent with
other definitions of nanoscale material or similar terms? If so, please
comment on whether such differences create any regulatory issues. In
particular, does the focus on ``intentionally produced'' materials
create any such inconsistency with other definitions of nanoscale
materials or similar terms?
    8. If a pesticide is identified as containing a particular
nanoscale material, what would be the most useful next steps to inform
EPA's understanding of potential risks associated with the pesticide?
Are there tests that could provide useful information toward an
understanding of risk that would be common to all nanoscale materials,
or should the data requirements necessarily be compound- and situation-
specific? How should bioavailability be considered in determining
testing requirements (e.g., are nano-particles respirable or bound to
other components)?
    With respect to the proposed approaches, EPA is seeking comment on
how to implement them to ensure efficient, effective, and timely review
of applications. EPA specifically invites comments on the following
issues:
    1. Is there a way to determine, in advance of receiving an
application for registration of a product containing a nanoscale
material, whether a particular kind of nanoscale material has
properties that, for purposes of risk assessment, are essentially the
same as larger sized materials of the same substance? If so, how would
such determinations be made and on what would they be based?
    2. What kinds of information should EPA accept as demonstrating
that a pesticide product containing a nanoscale ingredient is identical
or substantially similar to a currently registered pesticide or differs
only in ways that would not significantly increase the risk of
unreasonable adverse effects on the environment, and that approving the
registration in the manner proposed would not significantly increase
the risk of any unreasonable adverse effect on the environment?
    3. Can you suggest any alternative(s) to the proposed approaches
that would be equally or even more effective in addressing the status
of nanoscale materials as new active or inert ingredients for purposes
of both FIFRA and PRIA, keeping in mind the data showing that size,
especially when reduced below approximately 100 nm, may alter the
manner in which materials behave and, in turn, the potential risk to
human health and the environment associated with such materials?
    With respect to the potential alternative ways of obtaining the
needed information on what nanoscale materials are in pesticide
products, EPA specifically invites comments on the following issues:
    1. Has EPA appropriately characterized in this document the current
scientific understanding of the potential risks of nanoscale materials?
If not, please comment on how to characterize the potential risks of nanoscale materials. How would the  perception of the risks of nanoscale materials differ depending on the  approach used by EPA to require needed data on nanoscale materials in  pesticides? How could EPA lessen the possibility that issuance of a
final requirement to report what nanoscale materials are in pesticides
will result in a public misunderstanding of the potential risks of
nanotechnology more generally?
    2. Do commenters believe that identification of the nanoscale
materials in pesticide products is relevant to EPA's statutory
determination regarding the potential for unreasonable adverse effects
on the environment? Please provide the scientific or legal basis for
your view.
    3. Has EPA characterized the alternative approaches with respect to
which they would: (a) result in a misunderstanding of the potential
risks posed by nanoscale materials; (b) result in the timely submission
of needed information; and (c) impose burdens on pesticide companies,
those whose products do, and do not, contain nanoscale materials? If
not, please comment on those issues.
    4. If EPA uses FIFRA section 6(a)(2) to obtain the needed
information on nanoscale materials in pesticides, how could the Agency
ensure that its action is not mischaracterized or misunderstood as a
determination that the mere fact that a pesticide contains nanoscale
materials causes unreasonable adverse environmental effects?
    5. If EPA were to use DCIs to obtain the needed information on
nanoscale materials in pesticides, how could EPA reduce both the
burdens on registrants and on EPA, as well as the time required to
complete such a process? For example, is it possible to reduce the
burdens on registrants by targeting only certain types of products? If
so, how would EPA determine which products should receive DCIs?
    6. What are the advantages and disadvantages of requesting
information on nanoscale materials specifically versus requesting
information on size distribution generally? (Note that either type of
information could be collected under either the 6(a)(2) or the
3(c)(2)(B) approach, except that 6(a)(2) cannot be used to require the
production of new information that does not already exist, while a
collection under 3(c)(2)(B) must be directed to an individual
registrant and requires a response.) Is identifying what nanoscale
materials are in products a useful first step, or should EPA move
towards immediate collection of more specific information, such as
particle size distribution, on products that might contain nanoscale
materials? Are there other physical and/or chemical properties that
might be equally or more important for assessing the potential of a
pesticide to cause unreasonable adverse effects on the environment
(e.g., morphology, including shape and crystal structure; surface
chemistry and reactivity; specific surface area, charge; solubility;
conductive, magnetic, and optical properties)? Should information on
these properties be separately requested? What would be the value and
burden of obtaining such information?
    1. If EPA were to use rulemaking to establish data requirements for
pesticides containing nanoscale materials, what types of information
should EPA use to determine appropriate data requirements? What types
of studies should EPA require to evaluate a nanoscale material?
    2. When choosing an approach for obtaining needed data, how should
EPA weigh considerations relating to the need to update its safety
evaluations of currently marketed pesticides in a timely manner, the
goal of ensuring marketplace equity, and the interest in minimizing the
burdens on regulated entities?

 

Comments need to be filed by July 18, 2011, either in an e-format via www.regulations.gov or delivered in paper to

Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
    Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
   

Further information on submitting comments may be found at the head of the notice. A docket - EPA-HQ-OPP-2010-0197 - has been established on the Regulations.gov site. A few comments have been filed and may be viewed there, along with supporting and related materials used by EPA in drafting this notice. Members of the Nanotech community are encouragef to file appropriate comments by the July 18, 2011 deadline. Following receipt and review of comments filed by the July 18, 2011 deadline, EPA will publish another notice summarizing the comments.

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.