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2012 was to be a busy and significant year for the US Food Safety Modernisation Act (FSMA). Signed into law in 2011, the last 12 months have seen the majority of its programmes drafted but unfortunately because of government review procedures no major programme has been implemented yet. Tasked with developing some 90 rules, guidance documents and reports to meet the new FSMA requirements the Food and Drug Administration (FDA) has made some progress. Most notably, back in February the FDA published the Record Access Guidance and Interim Rule and in October the Biennial Facility Registration system was launched.
Record access guidance allows the FDA access to records including: manufacturing, raw materials (ingredients and packaging) receipts, product distribution, testing, recalls and reportable foods, customer distribution as well as complaints and adverse events in all registered facilities. If requested these records must be provided to the FDA within 24 hours. Failure to do so can result in the suspension of a facility’s registration, recalls, injunctions or product seizures.
Biennial Registration for all facilities opened on October 22, 2012 and all renewals must be submitted by December 31, 2012. Failure to re-register through this process may result in suspension of registration, as of January 1, 2013. Facilities whose registration is suspended cannot ship products into the USA, nor can they ship goods within the country. Other FSMA rules, guidance documents and reports achieved by the FDA include:
In addition, the FDA has made very substantial progress on other major FSMA deliverables, including:
On January 04, 2013 the US FDA issued the proposed preventive controls for human food and the produce safety standards. US FDA will receive comments to these proposals until 16 May 20134. Some 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 Centres for Disease Control and Prevention. The FSMA will better protect public health by strengthening existing food safety systems and proving oversight of producer and processor compliance. For more details on SGS Food services visit: www.sgs.com/foodsafety.
For further information, please contact:
Jim Cook Consumer Testing Services Food Safety Technologist SGS North America, Inc. t +1 973 461 1493
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 75,000 employees, SGS operates a network of over 1,500 offices and laboratories around the world.