January 27, 2011

Jackson Signs Proposed Rule Amending Human Subjects Protections Rule

On January 18, 2011, U.S. Environmental Protection Agency (EPA) Administrator Lisa Jackson signed a proposed rule that would revise EPA’s February 6, 2006, final rule concerning protections for subjects in human research. According to EPA, the proposed amendments would broaden the applicability of the rules to cover human testing with pesticides submitted to EPA under any regulatory statute it administers. The proposed amendments would also disallow participation in third-party pesticide...
January 25, 2011

ABA Publishes New Book on Product Liability

We are pleased to announce that the American Bar Association (ABA) has published a new book, entitled Product Liability, which Lynn L. Bergeson co-authored. Product Liability presents business and policy advisory perspectives on issues in product liability emerging from current changing legal and global market conditions. Bergeson co-authored the chapter entitled “New on the Horizon: Nanotechnology.” More information is available online....
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...
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...
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...