On November 30th, the U.S. Senate passed the FDA Food Safety Modernization Act (S. 510). Generally, the bill makes sweeping changes to food safety regulation and increases the FDA's enforcement power. The legislation requires food production facilities to implement a preventative food safety plan that must be provided to FDA inspectors. It also grants FDA inspectors greater authority to inspect safety records and facility documents if a food safety emergency occurs. Inspections of facilities will occur more frequently. Within five years of the bill's passage, all U.S. facilities will be inspected, and within one year of the bill's passage, at least 600 foreign food facilities will be inspected. Inspectors will have the ability to initiate mandatory recalls, but only after an informal hearing with the food manufacturer. The bill also provides the FDA with enhanced tracking and tracing of high-risk foods in the event of a food safety crisis. This will enable the FDA to conduct tracebacks of contaminated food and determine where the contamination occurred.
The bill also increases regulation of food products produced internationally. Importers of food products will be required to certify the safety of their foreign supplier and the food products they import. The FDA is granted the power to require certification of certain high-risk foods and to deny entry of food products that lack certification or that originate from a facility where FDA inspectors are not permitted.
An amendment added to the legislation shortly before Thanksgiving exempts small farmers who sell directly to consumers and waives requirements for food producers whose yearly gross sales are less than $500,000.
The bill will now go before the U.S. House of Representatives. In July of 2009, the House passed their version of the bill, the Food Safety Enhancement Act of 2009 (H.R. 2749), which is not as business-friendly as the Food Safety Modernization Act. While it is possible the House may attempt to reconcile the Food Safety Enhancement Act with the Food Safety Modernization Act, early reports speculate that the House will choose to approve the Food Safety Modernization Act rather than allow both bills to expire at the end of the year. Assuming that the bill is passed by the House, it then will be sent to President Barack Obama to sign into law.