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 10, 2011
CPSC Will Hold Web Conferences on the Publicly Available Consumer Product Safety Information Database
On January 7, 2011, the U.S. Consumer Product Safety Commission (CPSC) announced that it will hold two live web conferences on the publicly available consumer product safety information database. During the first web conference, scheduled for January 11, 2011, CPSC will demonstrate key functions of the database, such as how a consumer will be able to use the new online reporting form to submit a report of harm related to the use of a consumer product and how users can search for reports of harm...
Thank you for participating in Bergeson & Campbell, P.C.’s webinar on endocrine disruptors Monday, December 20, 2010. We are delighted that you were able to participate, and hope that you found the information and format useful and convenient. Request the materials from this webinar.
The California Department of Toxic Substances Control (DTSC) released a December 23, 2010, letter from Linda S. Adams, California's Secretary for Environmental Protection to Assembly Member Mike Feuer, the author of the 2008 law (A.B. 1879) that would require regulations to address chemicals and chemical ingredients in consumer products. In the letter, Secretary Adams responded to Feuer's letter outlining his concerns about the DTSC's November 16, 2010, release of revisions to its "Safer...
On December 6-7, 2010, the State Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Issues Research & Evaluation Group (SFIREG) held its semi-annual full committee meeting at the U.S. Environmental Protection Agency's (EPA) offices in Arlington, Virginia. Through a cooperative agreement in 1978, EPA and the Association of American Pesticide Control Officials (AAPCO) created SFIREG, an AAPCO committee with EPA funding, to promote information exchange and cooperation between the...
On December 17, 2010, the California Office of Environmental Health Hazard Assessment (OEHHA) issued proposed regulations that would specify hazard traits, environmental and toxicological endpoints, and other relevant data that are to be included in the Toxics Information Clearinghouse (Clearinghouse) the California Department of Toxic Substances Control (CDTSC) will develop. CDTSC will use information from the Clearinghouse to help identify chemicals of concern in consumer products as part of...
December 14, 2010
Korea Publishes List of Potential GHS Classifications and Plans to Issue New Material Safety Data Sheet Rules
Korea has taken a major step toward achieving full compliance with the United Nations Globally Harmonized System (GHS) for the classification and labeling of chemicals by identifying 151 substances as "hazardous" for consultation. The Ministry of the Environment (MoE) in Korea also is placing more responsibilities on manufacturers and importers by introducing new rules regarding updating and content of material safety data sheets (MSDS). The MoE has given companies just ten days to comment on...
December 13, 2010
CPSC Promulgates Final Rule Regarding Publicly Available Consumer Product Safety Information Database
On December 9, 2010, the U.S. Consumer Product Safety Commission (CPSC) promulgated the final rule establishing a publicly available consumer product safety information database, as required by Section 212 of the Consumer Product Safety Improvement Act of 2008 (CPSIA). The database must be publicly available, searchable, and accessible through CPSC's website. CPSC's final rule interprets various statutory requirements pertaining to the information to include in the database, and establishes...
December 10, 2010
EPA Will Hold Public Information Exchange on Nanomaterial Case Studies and Workshop on Nanoscale Silver
The U.S. Environmental Protection Agency (EPA) will announce in a Federal Register notice scheduled for publication on December 13, 2010, that it will hold a public information exchange meeting to receive comments and questions on the Nanomaterial Case Studies on January 4, 2011, in Research Triangle Park, North Carolina. According to EPA, the meeting will provide it an opportunity to highlight the Nanomaterial Case Studies and how EPA is using the studies as part of an ongoing...
Monday, December 20, 2010 1:30 p.m. - 3:30 p.m. (EST) Bergeson & Campbell, P.C. (B&C) is hosting a free webinar on endocrine disruptors on December 20, 2010. This webinar will provide an introduction to the issues associated with endocrine disruptors and testing strategies under the U.S. Environmental Protection Agency's (EPA) Endocrine Disruptor Screening Program (EDSP), while focusing on recent EPA developments that expand the regulatory scope beyond pesticide ingredients to...