US: FDA releases FSMA Produce Safety Rule

About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. FDA has compiled from CDC data information regarding produce associated outbreaks which occurred between 1996 and 2010 where contamination is likely to have happened early in the production chain, during growing, harvesting, manufacturing, processing, packing, holding, or transportation. This FDA data set demonstrates that from 1996 to 2010, approximately 131 produce-related reported outbreaks occurred, resulting in 14,350 outbreak-related illnesses, 1,382 hospitalizations and 34 deaths. These outbreaks were associated with approximately 20 different fresh produce commodities. This is a significant public health burden that is largely preventable.

The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on Jan. 4, 2011, enables FDA to better protect public health by strengthening the food safety system. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur.

As a key element of this preventive approach, FDA was mandated under FSMA to establish science-based, minimum standards for the safe growing, harvesting, packing, and holding of produce on farms to minimize contamination that could cause serious adverse health consequences or death.


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