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FDA Outlines FSMA Import Safety Mandates, Lists Completed Provisions
August 9, 2011 by Elizabeth Parker|FDA and EPA

The Food and Drug Administration has made available two presentations on the Food Safety Modernization Act (FSMA) -- one provides an overview of the new law, and the other focuses on its import safety provisions, which FDA states are the most groundbreaking shift of the FSMA. Both also list the implemented FSMA provisions.

Revised FDA Import Alerts on August 5
August 8, 2011 by Elizabeth Parker|FDA and EPA

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:

EPA Issues Supplement on Verification Testing for Energy Star
August 5, 2011 by Elizabeth Parker|FDA and EPA

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.

EPA Awards Contracts for Food Additive, Consumer Product, & Drug ToxCast Screening
August 5, 2011 by Kelly Sly|FDA and EPA

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.

FDA Adds Info on Federal/State Partnerships to FAQ on FSMA
August 5, 2011 by Barbara Chaves|FDA and EPA

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.

FDA, EU, Australia Report on Collaborative Drug Inspection Pilots
August 4, 2011 by Kelly Sly|FDA and EPA

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.

EPA Applauds Deal with Industry on Strict Auto Fuel Standards
August 3, 2011 by Kelly Sly|FDA and EPA

The Environmental Protection Agency reports that President Obama recently announced a historic agreement with thirteen major automakers to pursue the next phase in the Administration’s national vehicle program, increasing fuel economy to 54.5 miles per gallon for cars and light-duty trucks by Model Year 2025. The President was joined by Ford, GM, Chrysler, BMW, Honda, Hyundai, Jaguar/Land Rover, Kia, Mazda, Mitsubishi, Nissan, Toyota and Volvo -- which together account for over 90% of all vehicles sold in the U.S. -- as well as the United Auto Workers (UAW), and the State of California.

EPA Proposes Rule to Amend Tris SNUR to Allow Add'l Uses
August 3, 2011 by Kelly Sly|FDA and EPA

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.

FDA Seeks Comments on Medical Device Market Recommendations
August 3, 2011 by Kelly Sly|FDA and EPA

The Food and Drug Administration is requesting public comments on the Institute of Medicine’s report, “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years.” FDA is also planning a public meeting in the coming weeks to discuss recommendations made in the report. (In order for a manufacturer to begin marketing a device subject to 510(k) review, FDA must “clear” a premarket notification (510(k)) demonstrating that the new or modified product is substantially equivalent to another legally marketed “predicate” device.)