The Environmental Protection Agency is issuing significant new use rules (SNURs) under section 5(a)(2) of the Toxic Substances Control Act (TSCA), effective December 5, 2011, for 36 chemical substances which were the subject of premanufacture notices (PMNs). This action requires persons who intend to manufacture, import, or process any of these 36 chemical substances for an activity that is designated as a significant new use by this final rule to notify EPA at least 90 days before commencing that activity. See notice for list of 36.
On October 3, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
On September 30, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
The Environmental Protection Agency has released the final health assessment for trichloroethylene (TCE) to the Integrated Risk Information System (IRIS) database. The final assessment characterizes TCE, which is a widely used chlorinated solvent, as carcinogenic to humans and as a human noncancer health hazard. According to EPA, this assessment will allow for a better understanding of the risks from exposure to TCE in soil, water and air and provide policy makers with the latest information to make decisions about cleanup and other actions to protect human health.
The Food and Drug Administration has announced that it and other regulatory and international partners have completed the International Internet Week of Action (IIWA), a cooperative effort to curb online sales and distribution of counterfeit and illegal medical products.This year’s IIWA, called Operation Pangea IV, focused on websites supplying illegal and dangerous medicines (such as drugs containing human growth hormone (HGH), sildenafil citrate, or isotretinoin), and ran from September 20-27, 2011.
The Food and Drug Administration has updated its Questions and Answers document on the prevalence of arsenic in apple juice concentrate, including concentrate sourced throughout the world. The document was updated due to a Dr. Oz Show, and states that based on data collected by the FDA over many years, there is no evidence that juice on the market in the U.S. presents a public health risk from arsenic. The agency adds that testing results indicating total arsenic are not helpful, as it is only the inorganic arsenic (from some pesticides for example) that is harmful.
The Food and Drug Administration announces that the Device Registration and Listing Module (DRLM) of the electronic registration and listing system (FURLS) will be unavailable from 12:00 PM ET on Wednesday, September 28, 2011 until 8:00 AM ET on Saturday, October 1, 2011. The 2012 Annual Registration Cycle will begin on October 1, 2011.
On September 29, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
On September 28, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
On September 27, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of: