TAPPI International Conference Will Include "Lunch-n-Learn" Session

The June 6-8, 2011, Technical Association of the Pulp and Paper Industry (TAPPI) International Conference on Nanotechnology for Renewable Materials will include a “Lunch-n-Learn” session on June 6, 2011, from 12:00-1:00 p.m. (EDT). During the luncheon, which will be held in Washington, D.C., in Senate Visitors Center Room 201, TAPPI will introduce a Public-Private-Partnership model and its job creation potential in U.S. utilizing renewable nanocellulose materials. TAPPI will present leading edge research and development projects to help understand the significant impact federal investments give to keep the U.S. a global leader in manufacturing into the 21st century. RSVPs are due by 5:00 p.m. (EDT) on May 31, 2011.

SNWG Responds to BfR's Statement Concerning Nanosilver

The Silver Nanotechnology Working Group (SNWG) prepared a May 2, 2011, statement regarding the German Federal Institute for Risk Assessment's (BfR) April 12, 2011, statement concerning consumer products containing nanosilver. SNWG notes that, in December 2009, BfR published an opinion advising against the use of nanosilver in consumer products. Industry and other groups, including SNWG, asked BfR to reconsider its position, and BfR held a workshop on February 17, 2011, on nanosilver. SNWG states that, despite BfR’s assurance that follow-up dialogue would occur after the workshop, BfR instead issued its April 12, 2011, statement, which restated BfR’s initial opinion.  According to SNWG, BfR has “essentially ignore[d] the facts presented to BfR during the workshop.” SNWG reviews BfR’s concerns regarding nanosilver -- the use of silver aims to replace normal hygiene measures, the potential for bacterial resistance from silver, and claims of unusual effects of nanosilver -- and addresses each. SNWG highlights the benefits to consumers from antimicrobial products, including longer shelf-life and protection from the degrading action and colonization of bacteria. SNWG notes that BfR disregarded multiple references regarding the low risk of resistance to silver and wrongly singled out nanosilver to address a concern about silver resistance in general. Finally, SNWG rebuts BfR’s assumptions concerning the use of silver and nanosilver, and concludes that the “mode of action is therefore not unusual in comparison to other silver forms employed in the marketplace or used throughout history.” SNWG describes additional issues of concern regarding BfR’s position on nanosilver, including its misunderstanding of materials and history; the selective harm to small- and medium-sized enterprises; and its preemption of the European Union regulatory process.

Congressional Nanotechnology Caucus Seeks Members

In a May 2011 letter, Representatives Ralph M. Hall (R-TX) and Eddie Bernice Johnson (D-TX) ask Congressional members to join the bipartisan and bicameral Congressional Nanotechnology Caucus. The Caucus was formed over ten years ago and is intended to inform legislators about nanotechnology issues, including the effect of nanotechnology on job creation and other economic benefits to the U.S. The National Nanotechnology Initiative (NNI), which was codified by Congress in 2003, coordinates the federal nanotechnology research and development of 25 federal agencies. Since enactment, the House has passed bills in the 110th (H.R. 5940) and 111th (H.R. 554 and H.R. 5116) Congresses to amend and reauthorize the NNI, but the Senate did not act in either Congress. Since fiscal year 2008, the NNI has received funding through annual appropriations bills. Nanotechnology stakeholders are urged to use this template letter to let their representatives and senators know of the importance of nanotechnology issues to their constituents and urge them to participate in the Caucus.

ISO Publishes Standard for Nanomaterial Risk Evaluation

The International Organization for Standardization (ISO) has published a new standard, ISO/TR 13121:2011, which describes a process for identifying, evaluating, addressing, making decisions about, and communicating the potential risks of developing and using manufactured nanomaterials to protect the health and safety of the public, consumers, workers, and the environment.  According to ISO, the standard offers guidance on the information needed to make sound risk evaluations and risk management decisions.  The standard also includes methods to update assumptions, decisions, and practices as new information becomes available, and on how to communicate information and decisions to stakeholders. The standard offers methods organizations can use to be transparent and accountable in how they manage nanomaterials, and describes a process of organizing, documenting, and communicating what information organizations have about nanomaterials.

ECHA Preparing Nano Inventory from REACH and CLP Submissions

The European Chemicals Agency (ECHA) is compiling an inventory of nanomaterials included in the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration dossiers and Classification, Labeling, and Packaging (CLP) notifications for the European Commission (EC), and intends to deliver the inventory by the end of June 2011. The EC requested the inventory in response to the 2009 European Parliament communication on nanomaterials. An ECHA spokesperson stated that detailed results from the inventory would be available towards the end of 2011, and the inventory may be disseminated at a later date, but this has not yet been discussed. According to the spokesperson, ECHA has found three registration dossiers and 14 CLP notifications in which “nanomaterial” was selected as the form of the substance. The spokesperson stated that ECHA will be able to identify 50-60 REACH registration dossiers that include information on nanomaterials that will be sent to the Joint Research Centre for assessment under a separate project to address if and how information on nanomaterials is included in REACH registration dossiers.

EFSA Publishes Guidance for Assessing Engineered Nanomaterial Applications in Food and Feed

On May 10, 2011, the European Food Safety Authority (EFSA) published a guidance document for the risk assessment of engineered nanomaterial (ENM) applications in food and feed. According to EFSA, the guidance “is the first of its kind to give practical guidance for addressing potential risks arising from applications of nanoscience and nanotechnologies in the food and feed chain.” The guidance covers risk assessments for food and feed applications, including food additives, enzymes, flavorings, food contact materials, novel foods, feed additives, and pesticides. EFSA’s Scientific Committee prepared the guidance in response to a request from the European Commission (EC). EFSA states that the guidance complements existing guidance documents for substances and products submitted for risk assessment in view of their possible authorization in food and feed. The guidance stipulates the additional data needed for the physical and chemical characterization of ENMs in comparison with conventional applications, and outlines different toxicity testing approaches to be followed by applicants. The guidance presents six scenarios outlining different toxicity testing approaches. For each scenario, the guidance indicates the type of testing required. EFSA states: “Risk assessment of engineered nanomaterials is under fast development and consequently, in keeping with EFSA’s commitment to review its guidance for risk assessment on an ongoing basis, this work will be revised as appropriate.”

UCSF's Program on Reproductive Health and the Environment Publishes Recommendations for Addressing Health Risks from Nanomaterials in California

Last week, the University of California, San Francisco’s (UCSF) Program on Reproductive Health and the Environment announced the publication of its “Recommendations for Addressing Potential Health Risks from Nanomaterials in California,” which provides recommendations for addressing potential health risks from nanomaterials to the Office of Environmental Health Hazard Assessment (OEHHA) and to the state of California.  OEHHA contracted with UCSF to prepare the report, which provides an overview of nanotechnology materials, potential exposures, and human-health risks, and recommendations for addressing potential health hazards and risks from nanotechnology. Recommendations include those that can be implemented under the existing regulatory structure of OEHHA, such as establishing a publicly accessible clearinghouse and inventory of nanomaterial sources and products. The report also includes recommendations that are outside the scope of OEHHA, many of which may require legislative changes, such as requiring testing of release and exposure potential for nanomaterials in existing and new consumer products, and implementing a labeling system that requires labeling of products that contain nanomaterials.  According to UCSF, the recommendations primarily focus on requiring information on potential exposures and health hazards for nanomaterials used in the marketplace.

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EPA Issues Final SNUR for Certain Multi-Walled Carbon Nanotubes

On May 6, 2011, the U.S. Environmental Protection Agency (EPA) promulgated a final significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical substance identified generically as multi-walled carbon nanotubes (MWCNT), which was the subject of premanufacture notice (PMN) P-08-199. Under the final SNUR, persons intending to manufacture, import, or process MWCNT for a use that is designated as a significant new use by the final rule must notify EPA at least 90 days before commencing that activity. EPA states that it believes the final rule is necessary “because the chemical substance may be hazardous to human health,” and the required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. The final rule will be effective June 6, 2011.

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ITA Seeks Comments Concerning Regulatory Cooperation between the U.S. and EU

In an important and little noticed May 3, 2011, Federal Register notice, the U.S. Department of Commerce (DOC) International Trade Administration (ITA) requested public comments concerning regulatory cooperation between the U.S. and the European Union (EU) that would help eliminate or reduce unnecessary divergences in regulation and in standards used in regulation that impede U.S. exports.  Of critical importance, the ITA plainly recognizes and acknowledges that the main impediments to greater trade and investment between the U.S. and EU “are not tariffs or quotas, but rather differences in regulatory measures.” The ITA seeks public input to help identify divergences in regulatory measures in the transatlantic marketplace, “so that the U.S. Government can work cooperatively with the European Union to address them.” This notice offers an important opportunity to educate the ITA on subtle, yet significant trade impacts that are derivative of regulatory and/or competitive issues. ITA also seeks recommendations for existing or emerging industry or product sectors that may benefit from regulatory cooperation between the U.S. and the EU. ITA asks that submitters be as specific as possible in describing the relevant product or product sector in which they believe there is an opportunity to facilitate trade without undermining U.S. public health, safety, environmental, and other legitimate policy objectives. ITA states that it is interested in receiving recommendations concerning any product sector that, due to the volume of trade between the U.S. and EU, “is a justifiable focus of enhanced regulatory cooperation.” Comments are due June 2, 2011.

Nanodermatology Society Issues 2011 Position Statement on Sunscreens

In its 2011 position statement on sunscreens, the Nanodermatology Society states that it “believes that nano-based sunscreens do not pose serious health risks to consumers,” and agrees with the Environmental Working Group (EWG) that “[z]inc and titanium-based formulations are among the safest, most effective, sunscreens on the market.” According to the position statement, this is based on the current evidence showing:

  • Consumers using zinc and titanium sunscreen products are exposed to 20 percent less UVA radiation than those using sunscreens without these products;
  • Nano-titanium and zinc do not penetrate the outer layer of human skin, even through hair follicles; and
  • Nano-titanium and zinc do not reach living cells, and therefore pose no risk of toxicity.