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FSMA: Are you sure you are prepared?

FSMA will demand proof that processes and procedures elaborated in the GMP/HARPC plans are implemented, validated and verifiable.

FSMA compliance will not be judged by manuals and binders
FSMA compliance will not be judged by manuals and binders

Food and beverage processors have always been responsible for their own food safety measures, whether it be through on-site training, internal audits or improved track-and-trace technologies. However, with the new Food Safety Modernization Act (FSMA) taking effect in September, food manufacturers may experience a shift in food safety responsibilities.

“Let’s be clear on this point: Food safety has never been the responsibility of the U.S. Food and Drug Administration,” says Larry Keener, president and CEO of International Product Safety Consultants, LLC, Seattle, Wash. “To an extent, FSMA regulations will change that paradigm, and FDA will have a bigger stake in the ownership of food safety than it has in the past.”

For example, under FSMA, the U.S. Food and Drug Administration (FDA) can maintain recall authority for the first time in the agency’s history, according to Keener. FDA will also garner greater access to a company’s records and production-related data.

“The idea that FDA will ‘accept’ and/or ‘acknowledge’ the validity of a company’s preventative control plan is also emblematic of the agency’s increased ownership of food safety,” adds Keener. “Fundamentally, FSMA is bringing scientific methods to food safety and food production.”

So, what happens to those food manufacturers who fail to meet the September deadline?

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