Bergeson & Campbell, P.C. (B&C), B&C Consortia Management, L.L.C. (BCCM), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that Nanotechnology Law & Business has published an article co-authored by Lynn L. Bergeson entitled "RoHS Recast: How Did Nanomaterials Fare?" The abstract states: Several types of nanoscale materials recently dodged a bullet as the European Parliament declined to ban...
CHINA China Issues Fines For Non-Compliance With Requirements For Notification Of New Substances: China's Ministry of Environmental Protection (MEP) announced on February 9, 2011, that it fined six companies belonging to a U.S.-based corporation Yuan 30,000 (€3,300) for allegedly failing to provide ecotoxicological test reports by an MEP-approved laboratory. Beginning in October 2010, companies wishing to manufacture or import a new substance in...
Two of the trade associations named as negotiators by the U.S. Food and Drug Administration (FDA) regarding its proposal for the imposition of generic drug user fees have filed comments regarding the proposal that may frame their negotiating posture with the Agency going forward. The Society of Chemical Manufacturers and Affiliates' (SOCMA) Bulk Pharmaceutical Task Force and the European Chemical Industry Council's (CEFIC) Fine Chemicals Group urged FDA to impose a registration fee on each...
March 29, 2011
Senate Committee Holds Oversight Hearing on Disease Clusters and Environmental Health
On March 29, 2011, the U.S. Senate Committee on Environment and Public Works held a hearing entitled "Oversight Hearing on Disease Clusters and Environmental Health." Committee Chair Barbara Boxer (D-CA) and Senator Mike Crapo (R-ID), Ranking Member of the Superfund, Toxics, and Environmental Health Subcommittee, introduced the Strengthening Protections for Children and Communities from Disease Clusters Act (S. 76), also known as Trevor's Law, on January 25, 2011. The bill would require the U.S....
March 28, 2011
FDA to Hold Food Advisory Committee Meeting on Possible Link between Food Dyes and ADHD in Children
On March 30 and 31, 2011, the Center for Food Safety and Applied Nutrition (CFSAN) of the U.S. Food and Drug Administration (FDA) will hold a Food Advisory Committee meeting on the possible link between synthetic dyes in food products and behavioral issues in children, such as attention deficit hyperactivity disorder (ADHD). Members of the Food Advisory Committee have been charged to "consider available relevant data on the possible association between consumption of...
Bergeson & Campbell, P.C. (B&C), B&C Consortia Management, L.L.C. (BCCM), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that B&C is a proud sponsor of the American Bar Association's Section of Environment, Energy, and Resources' (ABA SEER) U.S. Environmental Justice and the Law Symposium, which will be held Friday, April 1, 2011, in Oxford, Mississippi. ABA SEER has collaborated with the University...
Now that the number of substances included on the European Union's Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Candidate List is up to 47 and counting, it is important to pay closer attention to requirements pertaining to substances of very high concern (SVHC). Article 7 of REACH requires producers, importers, and suppliers of articles to notify the European Chemicals Agency (ECHA) of the presence in articles of SVHCs that have been on the Candidate List for at...
March 24, 2011
Jayne Bultena Joins Bergeson & Campbell, P.C. and Brings Valuable Experience to Its FDA Practice
Bergeson & Campbell, P.C. (B&C), B&C Consortia Management, L.L.C. (BCCM), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that Jayne Bultena has joined B&C as Of Counsel. Ms. Bultena brings a distinguished background on a wide range of matters arising under the Federal Food, Drug, and Cosmetic Act. She has represented Fortune 100 companies, start-ups, and venture capital investors on several issues, including...
Effective April 18, 2011, Jim Willis, Director of the U.S. Environmental Protection Agency's (EPA) Office of Pollution Prevention and Toxics (OPPT) Chemical Control Division (CCD), will join the United Nations Environment Programme (UNEP) as the Executive Secretary of the Basel, Stockholm, and Rotterdam Conventions. Willis has been with EPA for more than 20 years in various staff through senior management positions. He also worked with UNEP for a number of years before...
March 23, 2011
China to Implement Globally Harmonized System of Classification and Labeling of Chemicals
On March 12, 2011, China's State Administration of Work Safety (SAWS) issued Decree 591, "Regulation on the Safe Management of Dangerous Chemicals," which concerns the safe use of chemicals. The regulation is very wide ranging in scope and "sets the tone" for future chemicals legislation. As one of the more immediate impacts, State Decree 591 uses the National Standards GB 13690-2009 on the general rules for the classification and hazard communication of chemicals, and GB 12528-2009 on...