Nano and Other Emerging Chemical Technologies Law Blog: Lawyer & Attorney : Bergeson & Campbell Law Firm : Nanotech and Chemical Legal Developments

On April 21, 2011, the United Kingdom’s (UK) Food Standards Agency (FSA) published a report of consumers’ views on the use of nanotechnology in food and food packaging. FSA convened a focus group in late 2010 and early 2011, and asked participants about their views on nanotechnology. According to FSA, the main findings are that:

• Participants’ reactions to nanotechnology and food reflected a variety of concerns. These included whether this was a necessary development, whose interests it would serve, and whether the benefits outweighed the perceived risks;
• Acceptance around the use of nanotechnology was conditional. For instance, participants were more positive about the use of nanotechnology to reduce the salt or fat content of foods without adversely affecting the taste or texture. Participants were negative towards the use of nanotechnology for what they perceived to be “trivial” purposes, however, such as using nanotechnology to develop new flavors and textures;
• Participants were relatively more open to the use of nanotechnology in food packaging and readily identified the potential benefits of extended shelf life and waste reduction. Participants questioned, however, whether consumers would receive the benefits of nanotechnology or whether these developments would be of most benefit to the food industry;
• The current way of regulating nanotechnologies in foods, the European Novel Foods Regulation, provided participants with a degree of confidence that the framework in place ensured the safety of nanotechnology in foods. Questions were raised, however, about the ability to predict long-term health effects of nanotechnology in food and whether wider social and environmental implications would be taken into account; and
• To provide further confidence in the use of nanotechnology in foods, participants wanted transparency about the developments, including providing them with more information. A register of foods that use nanotechnology, established by a body independent from industry and government, was received positively. The introduction of an “n” label for nanotech foods was also proposed, although participants recognized that consumers might not use or understand this information without complementary education and awareness raising.

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Environmental Science & Technology posted on April 5, 2011, an article entitled “Behavior of Metallic Silver Nanoparticles in a Pilot Wastewater Treatment Plant.” The abstract states:

We investigated the behavior of metallic silver nanoparticles (Ag-NP) in a pilot wastewater treatment plant (WWTP) fed with municipal wastewater.  The treatment plant consisted of a nonaerated and an aerated tank and a secondary clarifier.  The average hydraulic retention time including the secondary clarifier was 1 day and the sludge age was 14 days.  Ag-NP were spiked into the nonaerated tank and samples were collected from the aerated tank and from the effluent.  Ag concentrations determined by inductively coupled plasma-mass spectrometry (ICP-MS) were in good agreement with predictions based on mass balance considerations.  Transmission electron microscopy (TEM) analyses confirmed that nanoscale Ag particles were sorbed to wastewater biosolids, both in the sludge and in the effluent.  Freely dispersed nanoscale Ag particles were only observed in the effluent during the initial pulse spike.  X-ray absorption spectroscopy (XAS) measurements indicated that most Ag in the sludge and in the effluent was present as Ag2S.  Results from batch experiments suggested that Ag-NP transformation to Ag2S occur[r]ed in the nonaerated tank within less than 2 h.  Physical and chemical transformations of Ag-NP in WWTPs control the fate, the transport and also the toxicity and the bioavailability of Ag-NP and therefore must be considered in future risk assessments.

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Inhalation Toxicology has published an article entitled “Exposure assessment of workplace manufacturing nanosized TiO₂ and silver,” which monitored the possible exposure to nanoparticles at workplaces that manufacture nano-titanium dioxide (TiO₂) and nano-silver.  The abstract states:

To estimate the potential exposure of workers, personal sampling, area monitoring, and real-time monitoring using a scanning mobility particle sizer (SMPS) and dust monitor were conducted at workplaces where the workers handle nanomaterials. The gravimetric concentrations of TiO₂ ranged from 0.10 to 4.99 mg/m³, which were lower than the occupational exposure limit 10 mg/m³ set by the Korean Ministry of Labor or American Conference of Governmental Industrial Hygienists (ACGIH). Meanwhile, the silver metal concentrations ranged from 0.00002 to 0.00118 mg/m³, which were also lower than the silver dust 0.1 mg/m³ and silver soluble compound 0.01 mg/m³ occupational exposure limits set by the ACGIH. The particle number concentrations at the nano-TiO₂ manufacturing workplaces ranged from 11,418 to 45,889 particles/cm³ with a size range of 15-710.5 nm during the reaction, although the concentration decreased to 14,000 particles/cm³ when the reaction was stopped. The particle concentrations at the TiO₂ manufacturing workplaces increased during the reactor and vacuum pump operations, and during the collection of the synthesized TiO₂ particles. Similarly, the particle concentrations at the silver nanoparticle manufacturing workplaces increased when the sodium citrates were weighed or reacted with the silver nitrates, and during the cleaning of the workplace. The number of silver nanoparticles in the samples obtained from the workplace manufacturing silver nanoparticles using induced coupled plasma ranged from 57,789 to 2,373,309 particles/cm³ inside the reactor with an average size of 20-30 nm and 535-25,022 particles/cm³ with a wide range of particle sizes due to agglomeration or aggregation after the release of nanoparticles into the workplace air. In contrast, the silver nanoparticles manufactured by the wet method ranged from 393 to 3526 particle[s]/cm³ with an average size of 50 nm.  Thus, when taken together, the TiO₂ and silver nanoparticle concentrations were relatively lower than existing occupational exposure limits.

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On April 12, 2011, the German Federal Institute for Risk Assessment (BfR) issued a statement entitled “Safety of Nano Silver in Consumer Products: Many Questions Remain Open,” which reports BfR’s conclusions from a February 2011 workshop discussing existing risks and possible options for comprehensive consumer protection from nanosilver. According to BfR, “the situation continues to be characterised by the fact that not enough secured scientific findings about the specific effects of nano-sized silver particles are available.” BfR states: “Articles of daily use and consumer products may not constitute any health risk based on statutory provisions during proper use or foreseeable misuse. Since no final safety assessment for man and the environment is available so far for nanoscale forms of silver due to the missing data, BfR continues to advise against a broad use of nano silver in consumer products.”

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The Strategic Approach to International Chemicals Management (SAICM) Secretariat seeks input from stakeholders by May 1, 2011, for a forthcoming report on nanotechnologies and manufactured nanomaterials, which will focus on issues relevant to developing countries and countries with economies in transition. The report will include ten sections, covering beneficial uses of nanomaterials for health and the environment; economic and social impact; and work of international organizations. A section on risk assessment and management will focus on seven subtopics, including material characterization and risk management across the life cycle. The SAICM Secretariat intends to prepare a report based on the input it receives for consideration at the Open-Ended Working Group meeting, scheduled for August 29-September 2, 2011, in Belgrade, Serbia.

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On April 14, 2011, the House Science, Space, and Technology Subcommittee on Research and Science Education held a hearing entitled “Nanotechnology: Oversight of the National Nanotechnology Initiative and Priorities for the Future.” Witnesses included:

• Dr. Clayton Teague, Director, National Nanotechnology Coordination Office (NNCO);
• Dr. Jeffrey Welser, Director, Nanoelectronics Research Initiative, Semiconductor Research Corporation;
• Dr. Seth Rudnick, Chairman of the Board, Liquidia Technologies;
• Dr. James Tour, Richard E. Smalley Institute for Nanoscale Science and Technology, Rice University; and
• Mr. William Moffitt, President and Chief Executive Officer, Nanosphere, Inc.

The witnesses emphasized the need for Congress to reauthorize the National Nanotechnology Initiative (NNI) to ensure that the U.S. remains the global leader in nanotechnology. Other countries, such as Japan, China, and South Korea, have increased their investment in nanotechnology. Representative Mo Brooks (R-AL), Chair of the Subcommittee, thanked Dr. Teague for his service as Director of the NNCO. Dr. Teague’s last day will be April 15, 2011.

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On April 6, 2011, several members of the NanoSafety Consortium submitted to the U.S. Environmental Protection Agency (EPA) a proposed testing agreement under Section 4 of the Toxic Substances Control Act (TSCA). Under the proposed testing agreement, the substances to be tested may include multi-walled carbon nanotubes, double-walled carbon nanotubes, single-walled carbon nanotubes, and graphene nanoplatelets. Participants would conduct 90-day inhalation toxicity studies in rats, and submit interim progress reports to EPA at 60-day intervals, and a final report within 120 days of the conclusion of testing. Under the proposed testing agreement, if EPA promulgated a TSCA Section 5(a)(2) significant new use rule (SNUR) applicable to the test substances, then the testing agreement would have the status of a TSCA Section 5(b)(1)(A) test rule. The NanoSafety Consortium asked that EPA “expeditiously consider” the proposed testing agreement and begin the public comment and negotiation process at its “earliest possible convenience.”

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On April 14, 2011, the House Committee on Science, Space, and Technology Subcommittee on Research and Science Education will hold a hearing entitled “Nanotechnology:  Oversight of the National Nanotechnology Initiative and Priorities for the Future.” Witnesses will include:

• Dr. Clayton Teague, Director, National Nanotechnology Coordination Office;
• Dr. Jeffrey Welser, Director, Nanoelectronics Research Initiative, Semiconductor Research Corporation;
• Dr. Seth Rudnick, Chairman of the Board, Liquidia Technologies;
• Dr. James Tour, Richard E. Smalley Institute for Nanoscale Science and Technology, Rice University; and
• Mr. William Moffitt, President and CEO, Nanosphere, Inc.

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