The Food and Drug Administration issued its weekly Enforcement Report for April 18, 2012, that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On April 18, 2012, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On April 17, 2012, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Environmental Protection Agency is promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 17 chemical substances that were the subject of premanufacture notices (PMNs). This action requires persons who intend to manufacture, import, or process any of the 17 chemicals for a significant new use by this rule to notify EPA at least 90 days before beginning, giving the EPA a chance to evaluate it and possibly to prohibit or limit that activity. The rules take effect June 4, 2012.
During the week of April 10 through April 16, 2012, the Food and Drug Administration modified the following existing Import Alerts on the detention without physical examination of:
On April 17, 2012, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Environmental Protection Agency denied a petition for the EPA to revoke all pesticide tolerances for 2,4-dichlorophenoxyacetic acid (2,4-D) under section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), it said in a Federal Register notice to be published April 18. The petition was filed November 6, 2008, by the Natural Resources Defense Council. The NRDC had claimed that EPA's conclusion in the 2005 Reregistration Eligibility Decision (RED) for 2,4-D, which allowed 2,4-D to be reregistered and its tolerances retained, was based on a deficient risk. But the EPA said many of NRDC's claims fail to state a sufficient ground for revocation and instead merely critique the manner in which the risk assessment underlying the 2,4-D RED was done. Those claims that do allege relevant statutory grounds for revocation the EPA said it finds to be without merit.
Moon Marine USA Corporation (also known as MMI) of Cupertino, CA is voluntarily recalling 58,828 lbs of a frozen raw yellowfin tuna product, labeled as Nakaochi Scrape AA or AAA, according to the Food and Drug Administration. Nakaochi Scrape is tuna backmeat, which is specifically scraped off from the bones, and looks like a ground product. The Nakaochi Scrape AA and AAA from MMI was sold through distributors to restaurants and grocery stores that make sushi, and has been linked to an outbreak of Salmonella Bareilly, which has caused 116 illnesses in 20 states and the District of Columbia to date. Of the reported illnesses, there have been 12 hospitalizations, and no deaths.
The Food and Drug Administration issued its weekly Enforcement Report for April 11, 2012 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
The U.S. Environmental Protection Agency proposed a rule to require electronic reporting for information submitted to the agency under the Toxic Substances Control Act (TSCA), it said. The action is part of the agency's effort to increase transparency and public access to chemical information, it said in a press release, because electronic reporting will increase the speed with which EPA can make information publicly available and increase accuracy.