All Knowledge & Insights By Date

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...

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...

On February 13, 2009, the National Nanotechnology Coordination Office (NNCO) released a statement regarding the National Research Council’s (NRC) December 10, 2008, report regarding its review of the National Nanotechnology Initiative (NNI) Strategy for Nanotechnology-Related Environmental, Health, and Safety (EHS) Research.  According to the statement, NNI member agencies noted the report’s “substantial and important recommendations for further progress on EHS...

On February 18, 2009, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) published its opinion on the most recent developments in the risk assessment of nanomaterials.  In its opinion, SCENIHR indicates that methodologies to assess exposure to manufactured nanomaterials to humans and the environment and the identification of potential hazards require further development.  For lack of a general approach, SCENIHR maintains its...

On February 3, 2009, Representative Mike Honda (D-CA) introduced the Nanotechnology Advancement and New Opportunities (NANO) Act (H.R. 820), which is intended to ensure the development and responsible stewardship of nanotechnology. 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,...

On January 14, 2009, the Project on Emerging Nanotechnologies (PEN) released a report entitled A Hard Pill To Swallow: Barriers to Effective FDA Regulation of Nanotechnology-Based Dietary Supplements, which describes problems at the Food and Drug Administration (FDA) in regulating nano-enabled dietary supplements and offers recommendations for improving oversight. According to the report, FDA’s ability to regulate the safety of such dietary supplements “is severely limited by lack of...

On October 30, 2008, Consumers Union petitioned the Food and Drug Administration (FDA) to require a full safety assessment on the use of engineered nanoparticles, particularly in cosmetics, sunscreens, and sunblocks, and “to investigate possible enforcement action to ensure accurate labeling as to the presence or absence of nanoparticles.” Consumers Union cites new findings in the December 2008 issue of Consumer Reports, and states that the findings “confirm...

Last week, the U.S. Environmental Protection Agency posted a submission made by BASF Chemical Company under Section 8(e) of the Toxic Substances Control Act (TSCA), which requires U.S. chemical manufacturers, importers, processors and distributors to notify EPA within 30 calendar days of new, unpublished information on their chemicals that may lead to a conclusion of substantial risk to human health or to the environment. In its July 8, 2008, submission, BASF submitted the results of a...

On October 8, 2008, the European Commission (EC) published a regulation amending the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) Annex IV to remove carbon and graphite. Although the substances were originally listed in Annex IV, meaning they were exempt from REACH requirements because they were considered to be of minimum risk because of their intrinsic properties, a European Union (EU) expert committee delisted the substances in June 2008. According to the...

The Environmental Defense Fund (EDF) recently posted two blog items regarding a consent order negotiated by the U.S. Environmental Protection Agency (EPA). The October 9, 2008, item states that EPA intends to issue a sanitized version of a consent order negotiated with a producer of multiwalled carbon nanotubes (MWCNT). According to EDF, the order was prompted by EPA’s review of a premanufacturing notification (PMN). EDF obtained a redacted copy of the consent order, and...