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

On March 27, 2009, Lloyd’s of London issued a news release entitled “Nanotechnology: Balancing Risk and Opportunity.” According to the news release, over the past 18 months, the Lloyd’s Emerging Risks team has been examining the potential threats associated with nanotechnology from an insurance perspective. The release states: “Like others in the insurance industry, Lloyd’s is alert to the potential for nano products to be associated with health and safety risks, whether real or perceived.” According to the release, Lloyd’s believes that research and regulation “are the two critical tools which can help society and its insurers to better understand and manage the potential risks.” Lloyd’s states:

Research should be better co-ordinated, both at a national and an international level, while the many diverse applications of nanotechnology need a coherent regulatory framework.

Both of these are challenges that industry and government need to work on together, and the insurance industry can play a valuable part in this work.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

On March 24, 2009, the European Parliament (EP) approved an update of European Union (EU) legislation on cosmetics. The new regulation is intended to remove legal uncertainties and inconsistencies, while increasing the safety of cosmetics. The regulation would replace 27 different regulations. The new regulation addresses nanomaterials used as cosmetics ingredients. As requested by the EP, the new regulation introduces a safety assessment procedure for all products containing nanomaterials, which could lead to a ban on a substance if there is a risk to human health. The EP also succeeded in requiring that any nanomaterials present in cosmetics be mentioned in the list of ingredients on the packaging. The new regulation also includes a definition of nanomaterials, which must be adapted by the European Commission (EC) in line with scientific and technological advances. Under the new regulation, nanomaterial would be defined as “an insoluble or bioresistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.”

• Email This
• Print
• Comments
• Trackbacks
• Share Link

On March 17, 2009, the U.S. Food and Drug Administration (FDA) announced that it has completed a “proof-of-concept” study of a test that “quickly and accurately detects the presence of even the smallest amount of the deadly anthrax toxin.” According to FDA, the proof-of-concept study relies on a nanotechnology-based test platform built from tiny molecular-sized particles. The europium nanoparticle-based immunoassay (ENIA) was able to detect the presence of a protein made by the anthrax bacteria known as protective antigen (PA). PA combines with another protein, lethal factor, to form anthrax lethal factor toxin, the protein that enters cells and causes toxic effects. FDA states that its researchers showed that ENIA is capable of detecting PA in quantities that are 100 times lower than current tests, such as the enzyme-linked immunosorbent assay (ELISA). The ENIA uses nanospheres covered with thousands of light-emitting atoms of europium that emit light, which acts as a signal that PA is present. The ENIA detected PA in 100 percent of samples of mouse plasma compared to 36.4 percent through ELISA. A report on the results of this study appears in the March issue of Clinical and Vaccine Immunology.

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

On March 10, 2009, the Food and Drug Administration (FDA) announced a collaboration with the Alliance for NanoHealth (ANH) and its members. According to FDA, the collaboration is intended to “help speed development of safe and effective medical products in the emerging field of nanotechnology.” Under a memorandum of understanding, FDA and ANH will work to increase the knowledge of how nanoparticles behave and affect biologic systems, and to facilitate the development of tests and processes that could mitigate the risks associated with nanoengineered products. FDA states that all outcomes “will be placed in the public domain for the benefit of all stakeholders.” The ANH member institutions include Baylor College of Medicine; the University of Texas’ M.D. Anderson Cancer Center; Rice University; the University of Houston; the University of Texas Health Science Center at Houston; Texas A & M Health Science Center; the University of Texas Medical Branch at Galveston; and the Methodist Hospital Research Institute.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

On March 6, 2009, the United Kingdom (UK) Health and Safety Executive (HSE) published an information sheet on the risk management of carbon nanotubes (CNT). According to HSE, the information sheet “is specifically about the manufacture and manipulation of carbon nanotubes and has been prepared in response to emerging evidence about the toxicology of these materials. However, the risk management principles detailed here are equally applicable to other nanodimensioned bio-persistent fibres with a similar aspect ratio.” HSE cites as “new evidence” a recent study by the University of Edinburgh, which “found that long, straight [multi-walled CNTs] with a high aspect ratio produced a marked inflammatory reaction and the formation of granulomas when injected into the abdominal cavity of mice.”

• Email This
• Print
• Comments
• Trackbacks
• Share Link

On March 5, 2009, the European Food Safety Authority (EFSA) published a document entitled The Potential Risks Arising from Nanoscience and Nanotechnologies on Food and Feed Safety, which provides its scientific opinion on the potential risks arising from nanoscience and nanotechnologies on food and feed safety. EFSA’s Scientific Committee (SC) concluded that established international approaches to risk assessment can also be applied to engineered nanomaterials (ENM).  The SC also concluded that a case-by-case approach would be necessary and that, in practice, current data limitations and a lack of validated test methodologies could make risk assessment of specific nano products very difficult and subject to a high degree of uncertainty. The opinion focuses on the use of nanotechnologies, particularly ENMs, in the food and feed chain.  It elaborates on approaches and methodologies available for risk assessment of these very small particles but does not address any specific applications of particular ENMs.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

According to a February 27, 2009, National Institute for Occupational Safety and Health (NIOSH) Update entitled “Issues in Developing Worker Epidemiological Studies Related to Engineered Nanoparticles Are Discussed in Paper,” NIOSH scientists and a colleague from Emory University have prepared a paper concerning issues that researchers will need to consider in designing sound epidemiological studies of workers who may be exposed to engineered nanoparticles in the manufacturing and commercial use of nanomaterials.  According to the authors, even though the fundamental principles of epidemiology can be applied to engineered nanoparticles, researchers will face challenges typically not encountered in studies involving traditional materials. These challenges relate to the unique characteristics and properties of engineered nanomaterials, the relative newness of nanotechnology, and the fact that nanotechnology is not an industry in itself, but a process that may involve different industry sectors and occupational groups. The factors that would influence the design of an epidemiological study include:

• Heterogeneity (the chemical and physical diversity of engineered nanoparticles);
• Temporal factors (the challenge that nanotechnology, generally, has not been in use for the length of time it may take for some diseases to become apparent);
• Disease endpoints (determining what diseases or symptoms to look for on the basis of limited research evidence);
• Exposure characterization (determining what to measure and how to measure it); and
• Study population (finding a group of workers for a study who have been exposed to the same type of engineered nanoparticle at levels high enough and for a long enough time to provide scientifically reliable and comparable results).

The paper will be published by the Journal of Occupational and Environmental Medicine.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

During the February 18, 2009, Food and Drug Law Institute’s Second Annual Conference on Nanotechnology Law, Regulation, and Policy, Dr. Jonathan Sackner-Bernstein, Associate Center Director for Post-Market Operations at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), stated that FDA will not issue guidance until companies bring products to them so that FDA can learn more about the effects of nanotechnology. Sackner-Bernstein acknowledged that the companies might not be submitting products due to “uncertainty over excessive burden from regulation.”  He described FDA’s role as “an encouraging gatekeeper,” and urged companies to submit their products and test results. Deputy Director Douglas Throckmorton, FDA Center for Drug Evaluation and Research (CDER), stated:  “We are at work understanding what we have at hand, developing a full inventory of nanoscale products before we get into the guidance business.  But I will say this, we know much less than we need to on the effect of nanoscale materials on manufacturing.” Norman Alderson, FDA Associate Commissioner for Science, described the challenges of nano-engineered materials, including the lack of: standards and reference materials; toxicological and biocompatibility data for most products; and standardized physical and chemical characterization procedures.

• Email This
• Print
• Comments
• Trackbacks
• Share Link