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...
The January 21, 2011, issue of Pesticide & Toxic Chemical News quotes Lynn L. Bergeson regarding the effect of President Obama's January 18, 2011, Executive Order (EO). Bergeson stated that the EO is "welcome, appreciated and potentially useful, but it won't turn any ships around."
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...
The January 21, 2011, issue of BNA Daily Environment Report cites Bergeson & Campbell, P.C.'s January 3, 2011, memorandum regarding its 2011 predictions for the U.S. Environmental Protection Agency's Office of Chemical Safety and Pollution Prevention.
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...
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.
The January 14, 2011, issue of Pesticide & Toxic Chemical News quotes James V. Aidala regarding the U.S. Environmental Protection Agency's (EPA) decision to revoke tolerances for a fluoride-based pesticide. According to Aidala, EPA's use of aggregate risk in making its decision could raise questions.
January 13, 2011
Lynn L. Bergeson, “SCPA Delays Could Impact Industry,” Chemical Processing, January 2011.
In response to concerns expressed by diverse stakeholders over the final draft of its Safer Consumer Product Alternatives (SCPA) regulations, the California Environmental Protection Agency (CalEPA) has delayed implementation of the regulations, which focus on chemicals and chemical ingredients in consumer products. The net effect of this recent development on the regulation of chemical substances in consumer products in California is uncertain. This column discusses the recent change in plans...
January 13, 2011
Lynn L. Bergeson and Charles M. Auer, “Nano Disclosures: Too Small to Matter or Too Big to Ignore?,” Natural Resources & Environment, Winter 2011.
Determining whether the presence of nanoscale materials in chemical substances, mixtures, and articles triggers a disclosure obligation is complicated. The decision turns on a calculus that includes what law applies, what is known about the presence of nanoscale components, what knowledge standard applies, whether and how a nanoscale material is defined, and an entity’s interpretation of disclosure obligations. This article outlines the state of domestic environmental and securities law and...