The Environmental Protection Agency has announced the release of two new databases to make it easier to find data about chemicals. These databases, the Toxicity Forecaster database (ToxCastDB) and a database of chemical exposure studies (ExpoCastDB), can be used by scientists and the public to access chemical toxicity and exposure data.
The Food and Drug Administration is announcing the availability of two related draft guidances for industry and FDA staff entitled "Draft Guidance for Industry and FDA Staff: Classification of Products as Drugs and Devices and Additional Product Classification Issues" and "Draft Guidance for Industry and FDA Staff: Interpretation of the Term 'Chemical Action' in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act." To be considered for the final versions of these guidances, comments are due by September 19, 2011.
On June 17, 2011, the Food and Drug Administration posted a revised version of the following Import Alert on the detention without physical examination of:
As required by the Toxic Substances Control Act, the Environmental Protection Agency has issued "receipt and status" reports on the premanufacture notices (PMNs) and applications for test marketing exemptions (TMEs) that it has received from those intending to manufacture (which includes import) a new chemical (i.e., a chemical not on the TSCA Inventory). The notices cover the periods February 1, 2011 to April 22, 2011 and April 25, 2011 to May 20, 2011. Comments are due by July 20, 2011.
The Environmental Protection Agency has issued Federal Register notice seeking comment on several possible approaches for obtaining information about what nanoscale materials are present in registered pesticide products and their potential effects on humans or the environment. EPA is also proposing a new approach for how EPA will determine on a case-by-case basis whether a nanoscale active or inert ingredient is a “new” active or inert ingredient for purposes of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Pesticide registration Improvement Act (PRIA), even when an identical, non-nanoscale form of the nanoscale ingredient is already registered. Comments are due by July 18, 2011.
On June 16, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
On June 15, 2011, the Food and Drug Administration updated Import Alert #99-33 on the detention without physical examination of certain milk, milk products, fruit, vegetables, fish and baby formula from Japan due to radionuclide contamination. The update adds tea leaves from Ibaraki and Tochigi prefectures to the products from Japan subject to refusal of admission under Section 801(a)(2) of the Federal Food, Drug, and Cosmetic Act, under which products are detained and refused admission because they are forbidden or restricted in sale in the country in which they were produced or exported. Japan restricted these tea leaves from distribution into the market on June 2, 2011.
Researchers at the Food and Drug Administration's Center for Food Safety and Applied Nutrition have published a report on a study conducted on concentrations of bisphenol A in canned foods on the U.S. market. Metal cans are commonly coated with epoxy films made from polymers produced from BPA. The study found BPA concentrations in 71 of 78 canned food samples from the U.S., representing 16 different food types that constitute approximately 65% of U.S. canned food sales and canned food consumption. There were large variations in the BPA concentrations, and the only distinguishable trend was that fruits and tuna showed the lowest BPA concentrations. Higher BPA concentrations in canned food solids over liquid portions also indicated that BPA partitions into the solid portion of foods.
On June 15, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration's Center for Drug Evaluation and Research (CDER) Small Business Assistance Program announces a webinar series for small business entities to learn more about the FDA and basic drug regulation. The next webinar is on June 16, 2011, "Import of Human Drugs and Human Drug Components," which will focus on the compliance perspective of FDA’s import regulations on human drugs and human drug components. The discussion will include topics such as detention, refusal of admission, Transportation and Exportation (T&E) and Foreign Trade Zones (FTZ). Registration is available here.