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

On August 27, 2007, the Antitrust Division of the Department of Justice (DOJ) published a notice in the Federal Register announcing that, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. Sections 4301 et seq., the Nanoparticle Flow Processing Consortium has filed written notifications simultaneously with the Attorney General and the Federal Trade Commission (FTC) disclosing (1) the identities of the parties to the venture and (2) the nature and objectives of the venture. The notice states that the Consortium filed the notifications for the purpose of invoking the Act’s provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Pursuant to Section 6(b) of the Act, the identities of the parties to the venture are: 3M Company, St. Paul, Minnesota; The Proctor & Gamble Company, Cincinnati, Ohio; Corning Incorporated, Corning, New York; BASF Aktiengesellschaft, Ludwigshafen, Germany; and Imperial Chemical Industries PLC, London, United Kingdom. The general area of the Consortium’s planned activity is to: (1) develop, test, and validate computer-simulation technologies of near-term application that can improve the quality and reduce the cost of nanoparticle suspension/dispersion manufacture (including suspension stability and processibility); (2) transfer the technology developed under the Research and Development Program in a manner that offers the Consortium members opportunities for commercial advantage; and (3) develop methodologies and aptitude for modeling and simulation of multiscale phenomena intrinsic to the stability and dynamics of dense, nanoparticle suspensions.

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The European Commission (EC) Directorate General for Health and Consumer Protection retained GreenFacts to summarize the EC’s 2006 report entitled Modified Opinion (After Public Consultation) on the Appropriateness of Existing Methodologies to Assess the Potential Risks Associated with Engineered and Adventitious Products of Nanotechnologies. According to GreenFacts, the EC’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) wrote its Opinion for a scientific audience. GreenFacts prepared its summary for a broader audience. Continue Reading...

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Yesterday the Food and Drug Administration (FDA) released a proposed rule that would amend the final monograph for over-the-counter (OTC) sunscreen drug products as part of FDA’s ongoing review of OTC drug products. The proposed rule addresses formulation, labeling, and testing requirements for both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection, would introduce four-star rating system for the level of UVA protection, and would require a warning statement. FDA previously delayed regulations concerning UVA protection until reliable testing methodologies could be developed. The proposed rule specifically solicits comment on “the safety and effectiveness of sunscreen ingredients formulated in particle sizes as small as a few nanometers.”  Comments on the proposed avobenzone combinations will be due 60 days after publication of the Federal Register notice. Comments on all other parts of the proposed rule and on FDA’s economic impact determination will be due 90 days after publication in the Federal Register. Continue Reading...

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The California Department of Toxic Substances Control (CDTSC) will hold a symposium entitled “Nanotechnology Symposium II:  Potential Hazards of Nanomaterials in the Environment” on October 3, 2007. The draft agenda includes the following topics: 

• Chemical Properties and Commercial/Industrial Applications of Nanotechnology;
• Physico-Chemical Characterization of Nanoparticles and Its Relation to Their Bio-Interactions;
• Potential Ecotoxicity of Nanoparticles Released to the Environment;
• Nanomaterial Human Health Risks and Risk Assessment; and
• One Proactive Approach to Responsible Nanotechnology Development:  The DuPont -- Environmental Defense NanoRisk Framework.

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On August 14, 2007, the Department of Health and Human Services (DHHS) published a Federal Register notice announcing the 30th meeting of the President’s Council on Bioethics. The agenda items listed in the notice include “continue the exploratory phase of a potential inquiry into ethical issues associated with nanotechnology with expert presentations and Council discussions.” The meeting will be September 6-7, 2007.

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On August 16, 2007, the National Nanotechnology Coordination Office (NNCO), on behalf of the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the Committee on Technology, National Science and Technology Council (NSTC), published a notice in the Federal Register announcing the availability of a document entitled The Prioritization of Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials: An Interim Document for Public Comment, which assigns priority to research needs and areas identified in the NSET Subcommittee document Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials, which was published on September 21, 2006.  Comments are due September 17, 2007. Continue Reading...

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On August 3, 2007, EHP-in-Press posted an article entitled “Nanosize Titanium Dioxide Stimulates Reactive Oxygen Species in Brain Microglia and Damages Neurons, In Vitro.” The article describes the in vitro neurotoxicity of P25, a commercially available titanium dioxide nanomaterial. According to the study, P25 appears to be non-toxic to isolated N27 neurons, but stimulates BV2 microglia to produce reactive oxygen species and damages oxidative stress-sensitive neurons in cultures of brain striatum. EHP-in-Press articles have been peer reviewed and accepted for publication in Environmental Health Perspectives.

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The National Institute for Occupational Safety and Health (NIOSH) has posted several material safety data sheets (MSDS) for nanomaterials in its Nanoparticle Information Library (NIL). The goal of the NIL is to help occupational health professionals, industrial users, worker groups, and researchers organize and share information on nanomaterials, including their health and safety-associated properties.  To view the MSDSs, enter msds in the search field.

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On August 8, 2007, the European Commission (EC) released the scientific opinion of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on the appropriateness of the risk assessment methodology in accordance with the European Union’s (EU) technical guidance documents for new and existing substances for assessing the risks of nanomaterials. SCENIHR concluded that modifications to the existing technical guidance documents are necessary because special characterization of nanomaterial properties, which potentially differ considerably from conventional chemicals, is needed. Furthermore, the toxicological behavior and effects on health and the environment need to be assessed properly.  The opinion states that, due to the lack of common rules for the toxicology of nanomaterials, the risk assessment of nanomaterials should be done on a case-by-case basis. SCENIHR identified issues requiring improvements in the technical guidance and methodologies, and proposed a staged strategy for the risk assessment of nanomaterials. Special consideration is required for the assessment of the potential translocation of nanoparticles in humans and other species, and potential adverse effects, for example, within the cardiovascular system or following passage across the blood-brain barrier.

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On August 1, 2007, the Nanoethics Group announced the release of a collection of papers entitled Nanoethics: The Ethical and Social Implications of Nanotechnology, which addresses issues related to nanotechnology’s impact on society. The anthology includes papers from nearly 40 experts worldwide and includes topics related to benefits, risk, environment, health, human enhancement, privacy, military, democracy, education, humanitarianism, molecular manufacturing, space exploration, artificial intelligence, life extension, and more.

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On July 31, 2007, an international coalition of consumer, public health, environmental, and labor organizations issued the Principles for the Oversight of Nanotechnologies and Nanomaterials and called for strong, comprehensive oversight of the new technology and its products. According to the coalition, the manufacture of products using technology has “exploded in recent years,” while “evidence indicates that current nanomaterials may pose significant health, safety, and environmental hazards.” Continue Reading...

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On August 2, 2007, the U.S. Environmental Protection Agency (EPA) convened a public meeting on the Nanoscale Materials Stewardship Program (NMSP) under the Toxic Substances Control Act (TSCA). The meeting, which EPA had announced in a July 12, 2007, Federal Register notice, was well attended, with approximately 100 people in attendance. After introductory remarks by several EPA officials, various organizations presented their views on the NMSP and the associated draft documents made available by EPA on July 12, 2007. Among those offering comments were the American Chemistry Council (ACC) Nanotechnology Panel, Environmental Defense (ED), Consumers Union, the NanoBusiness Alliance, the International Council on Nanotechnology, and Dr. J. Clarence Davies of the Project on Emerging Nanotechnologies (PEN).

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On July 31, 2007, Representative Mike Honda (D-CA) introduced the Nanotechnology Advancement and New Opportunities (NANO) Act (HR 3235), which is intended to promote the development and responsible stewardship of nanotechnology in the U.S. Honda based the legislation on the recommendations of the Blue Ribbon Task Force on Nanotechnology, a panel of California nanotechnology experts with backgrounds in established industry, startup companies, consulting groups, non-profits, academia, government, medical research, and venture capital convened by Honda and then-California State Controller Steve Westly during 2005. Continue Reading...

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According to a recent survey presented at the Rural Futures conference in Canberra, Australia, nanotechnology in food and farming is inadequately regulated. Rural sociologist Dr. Kristin Lyons, Griffith University, stated: “Despite significant investment from the agrifood sector in nanotechnologies, the need for nano-specific regulation in this area hasn’t been recognised as a priority by the federal government.” Lyons said that the nano-agrifood industry will be worth more than US $20 billion by 2010.

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