January 24, 2011

FDA Proposal Responds to President Obama Order

The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) published on January 19, 2011, a "plan containing 25 actions it intends to implement during 2011 to improve the most common path to market for medical devices." See FDA News Release, "FDA to improve most common review path for medical devices" (Jan. 19, 2011), available online. That path is the Premarket Notification, or 510(k) process, used for the bulk of medical device reviews...
January 21, 2011

EPA Proposal on Nanoscale Chemicals, Final Inventory Rule Seen as Critical Issues

The January 21, 2011, issue of BNA Daily Environment Report quotes Lynn L. Bergeson and Kathleen M. Roberts regarding chemical policy and rulemaking efforts expected in 2011.  According to Bergeson, the 2011 election results will have a "large but uncertain impact" on the U.S. Environmental Protection Agency, reform of the Toxic Substances Control Act, and other issues.  Roberts stated that, if EPA releases the Inventory Update Reporting (IUR) rule in May, the chemical industry would not...
January 21, 2011

Bergeson & Campbell, P.C., “Nano Regulation and the New US Congress,” Nanotechnology Industries Association Newsletter, January 21, 2011.

The U.S. Environmental Protection Agency's (EPA) Office of Pollution Prevention and Toxic Substances (OPPT) and Office of Pesticide Programs (OPP) were both active with regard to nanoscale materials regulation and policy in 2010. The new year is expected to see comparable activity.
January 19, 2011

Lynn L. Bergeson Will Moderate Panel on International and State Regulatory Programs and Strategies for Addressing Nanoscale Materials

Bergeson & Campbell, P.C. (B&C), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that on January 27, 2011, Lynn L. Bergeson will moderate a panel discussing key nanotechnology-related international and state regulatory programs during a "quick teleconference" program sponsored by the American Bar Association (ABA) Section of Environment, Energy, and Resources entitled Nano Governance: The Current State of Federal, State, and International...
January 18, 2011

Environmental Science & Technology Article Reviews History of Nanosilver and Policy Implications

On January 10, 2011, Environmental Science & Technology posted a peer-reviewed pre-publication article entitled “120 Years of Nanosilver History:  Implications for Policy Makers,” which shows that nanosilver in the form of colloidal silver has been used for more than 100 years and, according to the authors, has been registered as a biocidal material in the U.S. since 1954.  The article states that 53 percent of the U.S. Environmental Protection Agency (EPA)-registered biocidal silver...
January 14, 2011

EFSA Begins Public Consultation on Draft Guidance on Risk Assessment for Nanoscience and Nanotechnologies

On January 14, 2011, the European Food Safety Authority (EFSA) began a public consultation on a draft document entitled “Guidance on Risk Assessment Concerning Potential Risks Arising from Applications of Nanoscience and Nanotechnologies to Food and Feed.” According to EFSA, the draft guidance offers practical guidance for the risk assessment of applications involving the use of nanoscience and nanotechnology in the area of food and feed (including food additives, enzymes, flavorings, food...
January 14, 2011

The Runoff

The January 14, 2011, issue of Pesticide & Toxic Chemical News notes that Lynn L. Bergeson blogged that B&C Consortia Management, L.L.C., will be working with BASF to create a consortium to respond to the California Department of Toxic Substances Control's (CDTSC) data call-in (DCI) on nano silver, nano zero valent iron, nano titanium dioxide, nano zinc oxide, nano cerium oxide, and quantum dots.