On August 8, 2011, the Food and Drug Administration posted a revised version of the following Import Alerts on the detention without physical examination of:
On August 5, 2011, the Food and Drug Administration posted a revised version of the following Import Alerts on the detention without physical examination of:
The Environmental Protection Agency announces that its ToxCast chemical screening program has awarded contracts to four U.S.-based companies to test up to 10,000 chemicals for potential toxicity to people and the environment. The four companies will initially screen up to 1,000 chemicals currently in the ToxCast program. The chemicals ToxCast is now screening are found in industrial and consumer products, food additives and drugs.
The Food and Drug Administration has updated its frequently asked questions document on the Food Safety Modernization Act to add information on Federal and State integration in implementing the FSMA. FDA explains how it will partner with state and local governments, the work of the Federal-State Integration team to develop and implement the Integrated Food Safety System (IFSS) with strengthened inspection, laboratory, and response capacity, etc.
The Environmental Protection Agency has issued a guidance document to serve as a supplement to its general requirements for EPA-recognized certification bodies for the ENERGY STAR program. The document pertains to selecting and obtaining products for verification testing, as well as reporting results to the EPA. The document also provides additional guidance to certification bodies on conducting the verification testing. Guidance document is available via email by sending a request to documents@brokerpower.com.
The Food and Drug Administration and its European and Australian counterparts have released reports detailing the results of two pilot programs on Active Pharmaceutical Ingredient (API) and Good Clinical Practice (GCP), which focused on increasing international regulatory collaboration to enhance drug quality and safety.
The Environmental Protection Agency has issued a proposed rule to amend the significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical substance identified generically as tris carbamoyl triazine, which was the subject to premanufacture notice (PMN) P-95-1098. This action would amend the SNUR to allow certain uses without requiring a significant new use notice (SNUN), and would extend SNUN requirements to certain additional uses. The proposed rule may affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA, and importers of chemicals subject to a final SNUR must certify their compliance with the SNUR requirements. Comments are due by September 2, 2011.
On August 2, 2011, the Food and Drug Administration posted a revised version of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration is reopening the comment period on its 2007 proposed rule on the “gluten-free” labeling of foods, in which FDA proposed to define the term “gluten-free,” for voluntary use in the labeling of foods, to mean that the food does not contain an ingredient that is any species of wheat, rye, barley, or a crossbred hybrid of these grains, wheat flour, or wheat starch, if the use of that ingredient results in the presence of 20 parts per million or more gluten in the food; or 20 ppm or more gluten. FDA is reopening the comment period for the proposed rule to solicit comments on a report, “Health Hazard Assessment for Effects of Gluten Exposure in Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten," among other things. Comments are due by October 3, 2011. FDA press release available here.
The Food and Drug Administration, together with its European and Australian counterparts, has released two reports detailing the results of pilot programs focused on increasing international regulatory collaboration among the agencies so that drug quality and safety can be enhanced globally. The report on the Good Clinical Practice (GCP) initiative details the success of information-sharing and collaboration on inspections relating to clinical trials; and the report on the Active Pharmaceutical Ingredients initiative details the success of information-sharing among the FDA, Australia’s Therapeutic Goods Administration and for Europe, the European Medicines Agency (EMA), France, Germany, Ireland, Italy, the United Kingdom and European Directorate for the Quality of Medicines & Healthcare (EDQM).