The Food and Drug Administration issued a proposed rule to amend the sterility test requirements for biological products, which is intended to provide manufacturers greater flexibility and to encourage use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. The more flexible requirements would also address the challenges of novel products that may be introduced to the market in the future and potentially enhance sterility testing of currently approved products, among other things. Comments are due by September 19, 2011.
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Drug Administration is announcing the availability of two related draft guidances for industry and FDA staff entitled "Draft Guidance for Industry and FDA Staff: Classification of Products as Drugs and Devices and Additional Product Classification Issues" and "Draft Guidance for Industry and FDA Staff: Interpretation of the Term 'Chemical Action' in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and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.
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 17, 2011, the Food and Drug Administration posted a revised version of the following Import Alert on the detention without physical examination of:
On June 16, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
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 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.
The Environmental Protection Agency is releasing two databases- the Toxicity Forecaster database (ToxCastDB) and a database of chemical exposure studies (ExpoCastDB) - that scientists and the public can use to access chemical toxicity and exposure data. Improved access supports the EPA Administrator’s priorities of protecting Americans’ health by assuring the safety of chemicals and expanding the conversation on environmentalism.
On June 15, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of: