On March 4, 2011, the California Office of Environmental Health Hazard Assessment (OEHHA) proposed to list four chemicals as known to the State to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop 65) under the "Labor Code mechanism" for listing contained in Health and Safety Code Section 25249.8(a). The four substances are: ChemicalCAS No.EndpointReferenceCyclopenta[cd]pyrene27208-37-3Cancer(2010a; 2010b)Ethanol in alcoholic beverages—CancerIARC (2010a;...
Category: FDA
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...
On September 21, 2010, the U.S. Food and Drug Administration (FDA) held a public hearing on the issue of labeling food made from the genetically engineered (GE) fish AquAdvantage Salmon, an Atlantic salmon produced by AquaBounty Technologies, Inc. The purpose of this hearing was to present the relevant legal principles for food naming and labeling, and describe information made available prior to the hearing about characteristics of AquAdvantage Salmon (e.g., the chemical composition and...
November 18, 2010
EPA Proposes EDSP Policies and Procedures for SDWA Chemicals and Issues Second List of Chemicals for EDSP Tier 1 Screening
On November 17, 2010, the U.S. Environmental Protection Agency (EPA) published draft policies and procedures for screening Safe Drinking Water Act (SDWA) chemicals under the Endocrine Disruptor Screening Program (EDSP). 75 Fed. Reg. 70558. "SDWA chemicals" are substances which "may be found in sources of drinking water if the Administrator determines that a substantial population may be exposed" (SDWA Section 1457). In the notice, EPA divided SDWA chemicals into two groups: those that are...
November 17, 2010
EPA Announces Second List of Chemicals for EDSP Screening and Publication of Proposed Policies and Procedures
On November 17, 2010, the U.S. Environmental Protection Agency (EPA) announced the second list of chemicals and substances for which EPA intends to issue test orders under the Endocrine Disruptor Screening Program (EDSP). 75 Fed. Reg. 70248. EPA states that the list of 134 chemicals "includes a large number of pesticides, two perfluorocarbon compounds (PFCs), and three pharmaceuticals (erythromycin, nitroglycerin, and quinoline). This list also consists of an array of other chemicals, ranging...
October 7, 2010
NIH and FDA Will Fund Research on Nanoparticles
In a September 27, 2010, press release, the National Institutes of Health (NIH) announced that it will award $9.4 million over three years to support four research projects in regulatory science. NIH will make the awards in partnership with the U.S. Food and Drug Administration (FDA), which will contribute approximately $950,000. According to the press release, the projects include research on nanoparticles and their characterization. NIH states that the projects were chosen “because...
September 30, 2010
Lynn L. Bergeson, “Toxicity Testing Moves Ahead,” Chemical Processing, September 2010.
Who would have thought that an automated laboratory working around the clock could screen chemical substances for interactions with biological targets at speeds mere mortals could hardly consider — let alone match? Well, this is exactly what is occurring today thanks to a collaborative effort known as "Tox21" among the U.S. Environmental Protection Agency (EPA), the National Toxicology Program (NTP), and the National Institute of Health Chemical Genomics Center (NCGC). Recently, the U.S....
September 8, 2010
R. David Peveler, Ph.D., Joins Bergeson & Campbell, P.C. and Its Consulting Affiliates, The Acta Group, L.L.C. and The Acta Group EU, Ltd
Dr. Peveler's Extensive and Diverse Experience in Domestic and Canadian Regulatory Matters Enhances B&C's and Its Affiliates' Growing International Chemical Industry Practice Areas Bergeson & Campbell, P.C. is pleased to announce that R. David Peveler, Ph.D. joined the firm's practice, and that of its consulting affiliates The Acta Group, L.L.C. and The Acta Group EU, Ltd on September 1, 2010. Most recently, Dr. Peveler served as a consultant to Evonik Degussa Corporation and managed a...
On September 23, 2010, the Food and Drug Administration (FDA) will hold a public workshop entitled “Medical Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations.” According to FDA, the purpose of the workshop is to obtain information on manufacturing, characterization, and biocompatibility evaluation of medical devices containing or using nanomaterials and nanostructures, including diagnostics. FDA is seeking input on these topics and...
On July 20, 2010, Representative Janice Schakowsky (D-IL) introduced the Safe Cosmetics Act of 2010 (H.R. 5786), which would amend the Federal Food, Drug, and Cosmetic Act (FFDCA) “to ensure the safe use of cosmetics.” Under the bill, the Secretary of the Food and Drug Administration (FDA) would: Monitor developments in the scientific understanding of any adverse health effects related to the use of nanotechnology in the formulation of cosmetics; and Consider scale-specific hazard...