ANEC and BEUC Announce 2010 Inventory of Consumer Products Containing Nanomaterials

On October 25, 2010, the European Consumer Voice in Standardisation (ANEC) and European Consumers’ Organisation (BEUC) announced their 2010 inventory of consumer products containing nanomaterials. According to BEUC, ANEC and BEUC began monitoring the availability of products containing nanomaterials in 2009, and that year’s inventory listed only 151 products. The 2010 inventory includes 475 products in categories such as child products, food and drink, cosmetics, products for cars, and electronic devices. ANEC and BEUC support the Belgian Presidency’s proposal to ensure the traceability of nanomaterials.

IJOEH Publishes Special Issue on Human and Environmental Exposure Assessment for Nanomaterials

The International Journal of Occupational and Environmental Health (IJOEH) has posted a special issue concerning human and environmental exposure assessment for nanomaterials. The issue includes articles such as “Understanding Workplace Processes and Factors that Determine Exposures to Engineered Nanomaterials,” “Nanotechnology and Exposure Science: What Is Needed to Fill the Research and Data Gaps for Consumer Products,” “Imaging and Characterization of Engineered Nanoparticles in Sunscreens by Electron Microscopy, under Wet and Dry Conditions,” and “Exposure Assessment:  Recommendations for Nanotechnology-Based Pesticides.”

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EC Begins Consultation on Recommendation on Definition of the Term Nanomaterial

On October 21, 2010, the European Commission (EC) began a consultation on its proposal for a definition of the term “nanomaterial” that the it intends to use as “an overarching, broadly applicable reference term” for any European Union (EU) communication or legislation addressing nanomaterials. The EC states that the definition of the term “nanomaterial” should be based on available scientific knowledge and should be used for regulatory purposes.  The definition should determine when a material should be considered as a nanomaterial for legislative and policy purposes in the EU. The EC proposes to define as a nanomaterial any material meeting at least one of the following criteria:

  • Consists of particles, with one or more external dimensions in the size range 1 nanometer (nm)-100 nm for more than one percent of their number size distribution;
  • Has internal or surface structures in one or more dimensions in the size range 1 nm-100 nm; or
  • Has a specific surface area by volume greater than 60 m2/cm3, excluding materials consisting of particles with a size lower than 1 nm.

The EC states that it intends to carry out a public consultation by 2012 and, if appropriate, review the adequacy of the definition “taking into account experience gained, scientific knowledge and the technological development.”

Australia Announces Adjustments To NICNAS New Chemicals Processes For Industrial Nanomaterials

In an October 5, 2010, Chemical Gazette notice, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) announced that it is introducing new administrative processes for the notification and assessment of industrial nanomaterials that are considered to be new chemicals. The new administrative arrangements will be effective from January 1, 2011, and will apply to any new chemical that falls under the following working definition of “industrial nanomaterial”:

. . . industrial materials intentionally produced, manufactured or engineered to have unique properties or specific composition at the nanoscale, that is a size range typically between 1 [nanometer (nm)] and 100 nm, and is either a nano-object (i.e. that is confined in one, two, or three dimensions at the nanoscale) or is nanostructured (i.e. having an internal or surface structure at the nanoscale).

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ASTM Nanotechnology Committee Creates Subcommittee on Nano-Enabled Consumer Products

Last month, the ASTM International Committee E56 on Nanotechnology announced the creation of Subcommittee E56.06 on Nano-Enabled Consumer Products. According to ASTM, the Subcommittee will develop standards for determining the presence of engineered nanomaterials in consumer products and understanding the potential for exposure from the use of these consumer products. The Subcommittee will focus its initial efforts on the identification and evaluation of engineered nanomaterials in consumer products.

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NIH and FDA Will Fund Research on Nanoparticles

In a September 27, 2010, press release, the National Institutes of Health (NIH) announced that it will award $9.4 million over three years to support four research projects in regulatory science.  NIH will make the awards in partnership with the U.S. Food and Drug Administration (FDA), which will contribute approximately $950,000.  According to the press release, the projects include research on nanoparticles and their characterization. NIH states that the projects were chosen “because they were the most meritorious proposals for addressing high priority areas in cutting-edge biomedical research and regulatory science.” Dennis E. Hourcade, Ph.D., Washington University, St. Louis, will receive funding for “Characterization/Bioinformatics-Modeling of Nanoparticle:  Complement Interactions.” NIH defines regulatory science as “the development and use of the scientific knowledge, tools, standards, and approaches necessary for the assessment of medical product safety, efficacy, quality, potency, and performance.”

OPP Considering Labeling of Nanopesticides

The State Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Research and Evaluation Group (SFIREG) Pesticide Operations and Management (POM) Committee held a meeting on September 20, 2010. During the meeting, Jennifer McLain, Associate Director of the Antimicrobials Division, U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP), provided an update on EPA’s regulation of pesticides containing nanoscale materials. McLain’s presentation includes two previously unreported OPP regulatory activities. First, according to McLain, OPP intends to require that nanoproducts be labeled in the same way as other pesticide products. Ingredients would be listed as “nano-X,” and OPP would evaluate the claims on a case-by-case basis. Second, OPP apparently is considering issuing data call-ins to obtain information EPA may need to evaluate the registerability under FIFRA of nanoscale materials. Using its FIFRA data call-in authority is, of course, an option several industry groups have been urging in lieu of repurposing FIFRA Section 6(a)(2).

Plainly, OPP’s cryptic reference to FIFRA “nano labeling” requires far more explanation and some observers may find it disturbing. The presentation’s statement that “Nano-Products will be labeled the [sic] in the same way as other pesticide products” is, of course, ambiguous at best. Such an approach would lead to a number of important questions: What exactly is subject to labeling? Will the presence of any nanoscale material in a formulation trigger a nano label? How will confidentiality issues be addressed? The presentation raises other thorny issues, many of which appear to not have been publicly discussed.