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The FDA Food Safety Modernization Act (FSMA) Affects the Entire Food Supply Chain

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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. 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, 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. The law also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur.

The law also gives FDA important new tools to hold imported foods to the same standards as domestic foods and directs FDA to build an integrated national food safety system in partnership with state and local authorities. Building a new food safety system based on prevention will take time, and FDA is creating a process forgetting this work done.

Congress has established specific implementation dates in the legislation. Some authorities will go into effect quickly, such as FDA’s new authority to order companies to recall food, and others require FDA to prepare and issue regulations and guidance documents.

The funding the Agency gets each year, which affects staffing and vital operations, will also affect how quickly FDA can put this legislation into effect. FDA is committed to implementing the requirements through an open process with opportunity for input from all stakeholders.

There are affiliates that can train and certify international and US food and food transportation companies on the sanitation, traceability, and temperature monitoring to meet the requirements of this FDA/FSMA regulations.

The law requires FDA to write the regulations that were authorized by the Sanitary Transportation Act of 2005 and does not provide FDA with any new authorities beyond what was included in the 2005 law. FDA is required to issue regulations to require that shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in transportation of food to use sanitary practices within the next year and half.

Every facet of the food supply chain, both ambient and frozen food will be part of this FDA/FSMA regulation for sanitation, traceability and temperature monitoring. Food during transportation will also be a big focus of FDA/FSMA. All trans ocean containers coming to the US will have to be washed by a certified wash station to meet FDA/FSMA regulations.

Dr. John Ryan is a specialist in the field: see SanitaryColdChain.com.

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The Business Case is an instrumental tool in both justifying a project (requiring a capital budgeting decision), as well as measuring the project's success. The Business Case model typically takes the form of an Excel spreadsheet and quantifies the financial components of the project, [read more]

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About Charles Intrieri

Charles Intrieri is subject matter expert on Cost Reduction, Supply Chain, and 3rd Party Logistics. He is also an author on Flevy (view his documents materials). Managing his own consultancy for the past 25 years, Charles has helped dozens of clients achieve leaner and more efficient operations. You can connect with him here on LinkedIn or email him directly (cmiconsulting93@gmail.com). Charles also has a presentation Why Lean Fails in a Company? available for free download here.

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