4 Key Elements of FSMA Compliance

August 19, 2011

By Sparta Editorial


Part I: What are the Elements and Focus of FSMA?

In the "Food Safety Modernization Act" blog series, Sparta will be examining the key elements and effects of FSMA as well how best to prepare for FSMA compliance. This is part one of three. The series continues with parts two and three

Each year 48 million Americans are stricken by food borne illnesses by compromised food, hospitalizing hundreds of thousands and killing thousands – this is the main reason FSMA includes prevention based regulation to cover all aspects of food similar to FDA’s currently established practices for poultry, seafood, juice and eggs. A breakdown at any point on the farm-to-table spectrum of the American food system can cause great harm to the health of consumers and tremendous business disruption to the food industry. The FSMA addresses accountability in the prevention of food borne illnesses throughout the food system both domestically and internationally, as part of food safety responsibility. Key points of the FSMA are:

- Authority - FDA would have the authority to issue direct recalls of suspected tainted food, rather than relying on individual producers to issue voluntary recalls.

- Prevention - Food producers are required to have food safety plans (hazard analysis and control plans for implementing corrective actions) accessible by FDA in case of emergency.

- Traceability - HHS is to create a food tracing system to streamline finding the source of contamination in case of an outbreak.

- Import compliance – Importers of food products are to be responsible to verify safety of imported food products and confirm it is in accordance with US food safety guidelines.

Similar to HAACP, processors of all food types will now be required to evaluate hazards in their operations; implement and monitor effective measures to prevent contamination; and in the case of any event, they should have plans to take corrective actions as necessary. As part of the enforcement, FDA will have tools to ensure plans are adequately and properly implemented, and sweeping new authority to suspend company registration, levy fines, gain broader access to records and issue mandatory recall to swiftly remove contaminated items. This includes fresh fruits and vegetables, safe transportation of food, and risk based inspection of food processing facilities.  Additionally, as part of the food products coming into the US from foreign countries, the importers are to verify the safety of these food products from their suppliers. FDA has the authority to block these supplies should those suppliers or countries deny inspection by FDA. As part of the safety emphasis, there are provisions to strengthen collaboration with other foreign food safety agencies, improve training at various levels (state, county, local, foreign, territorial) allowing for a well integrated, efficient and effective food safety system.

Look for part two of this article coming soon - How does the FSMA focus affect various food industry participants?

Part II

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