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FSMA

Blue Bell and the Very Real Impact of the Food Safety Modernization Act

Opinion

Blue Bell ice cream

(This article by Michael R. Taylor, Deputy Commissioner for Foods and Veterinary Medicine for the U.S. Food and Drug Administration, was originally posted here on May 20, 2015.) Could the deadly outbreak of illnesses tied to contaminated ice cream have been prevented? It’s an important question, one that is on the minds of many in… Continue Reading

FDA Chastised for Lack of FSMA-Required Recall Notification Guidance

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Many requirements of the Food Safety Modernization Act (FSMA) have yet to be implemented, and one of them is a recall notification system for grocery stores described in Section 211 of the law. The section on improving the Reportable Food Registry required that within one year of FSMA’s enactment in 2011, FDA “develop and publish… Continue Reading

FSMA Readiness: The Challenge of Implementation

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Last month, the U.S. Food and Drug Administration (FDA) hosted a “Kickoff Meeting” in Washington, D.C., for a new law promised to revolutionize the nation’s food system into one focused on preventing foodborne illness. That law, the Food Safety Modernization Act (FSMA), was enacted more than four years ago, but FDA is finally ready to… Continue Reading

A Proactive Plan: The First Step to FSMA Compliance

Opinion

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It’s been four years since Congress passed the Food Safety Modernization Act (FSMA), and the time has finally come for the U.S. Food and Drug Administration (FDA) to implement its requirements. FDA declared 2015 “the year of FSMA” at the agency’s “FSMA Kickoff Meeting” for food industry stakeholders on April 23, 2015. The first court-ordered… Continue Reading

FSMA Readiness: Litigation, Insurance, and Safeguards

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When Albany Law School Professor Tim Lytton attended the 2015 Food Safety Summit in Baltimore nearly two weeks ago, he could sense something, however faintly, among the crowd of food industry professionals: nervousness. For decades, he said, the public has been anxious about the safety of our food system. From the Jack in the Box E…. Continue Reading

FDA Publishes Draft Guidance on Mandatory Recall Authority

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On Wednesday, the Food and Drug Administration (FDA) published draft guidance for industry on its mandatory food recall authority that has been in effect since the Food Safety Modernization Act (FSMA) was enacted in January 2011. The recall authority was added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by Section 206 of… Continue Reading

FSMA Readiness: Accountability Starts at the Top, Just Like Sarbanes-Oxley

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As enforcement time nears for the Food Safety Modernization Act (FSMA), experts such as Repositrak’s Randy Fields are being heard making comparisons between FSMA and the 2002 Sarbanes-Oxley Act. The first major revamp of federal food safety laws since 1938 and the most-far reaching reforms of business practices “since the time of Franklin D. Roosevelt”… Continue Reading

Senators, Food Industry Groups Call for More FSMA Funding

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On the heels of a high-profile Listeria outbreak and the recall of all Blue Bell ice cream products, seven Democratic U.S. senators on Thursday called on the Senate Appropriations Committee to fully fund the federal Food Safety Modernization Act (FSMA) by approving President Obama’s request for an additional $109.5 million to implement the law. The U.S…. Continue Reading

Listeria Victims Address FDA, Food Industry Officials in D.C.

Brad Frey holds his phone while a video plays of his parents dancing in their driveway two years ago. His mother, Shirlee Jean, died from a Listeria infection in December after eating a contaminated caramel apple. Frey and other victims shared their stories with federal lawmakers last week in Washington D.C.

A year ago, Brad Frey never would have imagined he’d be standing in front of officials from the U.S. Food and Drug Administration and urging them to do more to prevent outbreaks of Listeria monocytogenes. Despite living in the middle of “crop country” outside Santa Cruz, CA, he had never heard of Listeria monocytogenes, a foodborne bacteria less well-known… Continue Reading

FDA Kicks Off the ‘Year of the Food Safety Modernization Act’

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In front of hundreds of food industry and trade association representatives in Washington, D.C., on Thursday, the U.S. Food and Drug Administration (FDA) presented its unified plan to roll out and implement the Food Safety Modernization Act (FSMA). Signed by President Obama in January 2011, FSMA will bring about the most sweeping changes to the U.S. food… Continue Reading