New Developments in Nanotechnology

A recent study suggests that exposure to nanoparticles may have caused the death of two female workers and the illnesses of five others in China. Life science health industry companies that manufacture, integrate, sell or buy products that contain nanomaterials may want to monitor reaction to this report, which may garner attention from media outlets, scientists, regulators and the plaintiffs' bar. For a full discussion of these issues, review the full Client Alert written by Reed Smith attorneys Antony Klapper, Jesse Ash and David Wagner.

CDC and NIOSH Review of Carbon Nanotubes Highlights Need for Tracking Regulatory Action Related to Nanotechnology

This post was written by Antony B. Klapper and Jesse J. Ash.

On April, 8, 2009, the National Institute for Occupational Safety and Health ("NIOSH") and the Centers for Disease Control and Prevention ("CDC") submitted a notice for public comment in the Federal Register, requesting information to evaluate potential health risks associated with the use of carbon nanotubes ("CNTs"). 74 Fed. Reg. 15985-15986 (Apr. 8, 2009). NIOSH and CDC request by May 15, 2009, all information related to studies, workplace exposure data and information on control measures where companies manufacture CNTs in products. The agencies plan to use this information to formalize recommendations for the safe handling of products that contain CNTs.

Recent scientific reports have drawn parallels between CNTs and asbestos. CNTs are long, thin particles similar to the needle-like shape of some asbestos fibers. In fact, these reports suggest that CNTs can cause adverse effects on the lung function of mice. These reports, in part, likely form the rationale for NIOSH's and CDC's focus on CNTs. Suggesting a connection between CNTs and the human health questions associated with asbestos is a sure way to gain the public's and the government's attention, even though the reports do not answer the critical question of whether CNT exposure can cause adverse consequences in humans, and are limited in a variety of ways. Regardless, this Notice from NIOSH and CDC demonstrates that the government is now highly concerned about the effects of CNTs on human health, and that it is focused on the future regulation of its use.

Companies that manufacture, integrate or sell nanomaterials, including, in particular, CNTs, need to be mindful of the actions taken as a result of this Notice. Companies should evaluate whether to communicate their views and/or findings to NIOSH and CDC by May 9, either through associations or directly. Whatever information NIOSH collects, and any guidance it may promulgate, could become the floor that companies may need to adhere to or risk future liability.

Nanotechnology - What the Life Sciences Industry Needs to Know about Managing its Risks

Reed Smith LLP, in conjunction with ChemRisk and the Center for Business Intelligence, is presenting a complimentary webinar, "Nanotechnology - What the Life Sciences Industry Needs to Know about Managing its Risks", October 22 at noon eastern.

The moderator for this event will be Reed Smith partner Antony B. Klapper. Speakers include:

  • Barr Weiner, Associate Director for Policy in the Food and Drug Administration's Office of Combination Products and the OCP representative on the FDA's agency-wide Nanotechnology Task Force
  • Leonard I. Sweet, Senior Health Scientist, ChemRisk, Inc.
  • Amy K. Madl, Senior Managing Health Scientist, ChemRisk, Inc.

The program will last one hour and will provide an overview of nanotechnology and its uses in the life sciences industry; actual and theoretical risks posed to humans by the use of engineered nanomaterials; the ways that life sciences companies can evaluate those potential risks and mitigate them through risk management practices and good product stewardship; and legal risks associated with engineered nanomaterials, and exploring next steps at the FDA and other regulatory bodies.

A link to register for this free program can be found at cbinet.com.