Saturday, January 08, 2011

The Foody Blues - FDA Of Future Passed

On January 4, 2011, President Obama signed into law the Food Safety Modernization Act ("FSMA"), which the U.S. Senate and House both passed in late 2010. The FSMA amends the existing Food, Drug and Cosmetics Act in numerous ways, but four changes stand out in particular:
(1) FDA must develop and employ science-based standards that govern the growing and harvesting of fruits and vegetables, and these standards must take into account both anthropogenic and "natural" risks to food safety,
(2) Food facilities must produce written assessments that identify risks to the food they handle, and specify prophylactic measures to minimum these identified risks,
(3) FDA must greatly step up its inspections of food facilities, both in the U.S. and abroad, and
(4) FDA will now possess enhanced recall authority, allowing the agency to force recalls of unsafe food if the producer of the food fails to do so voluntarily, and will be able to suspend registration of food facilities connected to unsafe food.
Here is how Food and Drugs Commissioner Margaret Hamburg describes the new FSMA
Each year, foodborne illness strikes 48 million Americans, hospitalizing a hundred thousand and killing thousands.  I thank the President and members of Congress for recognizing that the burden that foodborne illness places on the American people is too great, and for taking this action.
The historic legislation the President will sign tomorrow directs the Food and Drug Administration, working with a wide range of public and private partners, to build a new system of food safety oversight – one focused on applying, more comprehensively than ever, the best available science and good common sense to prevent the problems that can make people sick...
This law represents a sea change for food safety in America, bringing a new focus on prevention, and I expect that in the coming years it will have a dramatic and positive effect on the safety of the food supply.
Two of the greatest challenges faced by the FDA in implementing the FSMA will be time and money.  To meet the aggressive schedule of inspections and other actions mandated by the FSMA, the agency will have to hire many new employees with expensive scientific credentials.  The new Republican-dominated House may balk at supplying any new funds in the new era of austerity they have announced.  However, food safety is a very popular political issue, and woe betide the future electoral prospects of any politician seen to be advocating less of it.
More biolaw at LEXVIVO.


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