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FSMA Questions Unanswered + GAO Concerns = Compliance Concerns For Food PRoducers

Posted by Scott Nuelle on Mar 2, 2017 9:00:00 AM

More than a year ago now, the Food and Drug Administration released its final rule on Produce Safety (formally known as “Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption”).  The rule resulted from Congress’ passage of the Food Safety Modernization Act (FSMA) at the end of 2010 and constituted part of a major push to upgrade food safety procedures in the United States. However, a new report from the Government Accountability Office (GAO) calls into question the efficiency and efficacy of the FDA’s attempts to regulate this area.

What is the Produce Safety Rule?

The Produce Safety rule marked the first attempt by the FDA to make regulations covering issues such as the quality of water used in growing crops and the presence of both wild and domesticated animals on farms.  The rule established standards for growing, harvesting, and packaging produce meant for human consumption and constituted an ongoing attempt by the FDA to focus on preventing food-borne illness rather than reacting to cases after the fact.

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GAO Became Involved With The Farm Bill

Concerns about the high cost of compliance led Congress to pass a provision in the 2014 Farm Bill that required the FDA to address and respond to ongoing concerns by agricultural businesses.  As part of that act, the GAO issued a report on Monday November 28, 2016 assessing and auditing the efficacy of the FDA response efforts.  (In a nice of example of government bureaucracy, the GAO also had to address the effectiveness of how the FDA plans to address the effectiveness of its response efforts).

The FDA Leaves Many Questions Unanswered

Solely examining the Produce Safety Rule, the FDA has received over three hundred and fifty questions on the implementation of the new rule and over hundred of those questions remain unanswered.  The agency has taken on average over three weeks to respond to questions and has often had to refer questions to subject matter experts.  Compounding the problem, the agency continues to develop additional guidance on complicated issues such as agricultural water and therefore has delayed answering questions on those topics.

Food Producers Scrambling To Comply

These issues put producers trying to gear up for meeting new regulatory standards in a difficult position as they prepare to bear the added cost of the new regulatory burden they face.  The rule goes into effect for large producers in one year and industry groups are doing what they can to provide necessary guidance for producers trying to be ready to meet the rule’s standards within that timeframe.  The FDA has earmarked significant funds for educating producers about the requirements in the new rule and helping them meet those requirements.

Smaller Producers Are Playing Catchup

For many large packagers and transporters of food products, the changes brought by FDA rules seeking to implement FSMA represented actions they had already begun performing themselves.  The produce rule, though, represents more of a sea change in how many businesses, especially smaller ones, will operate.  People within the food supply chain, including growers, processors, and transporters, need to keep up to date with these new changes to ensure they toe the line.

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Topics: Manufacturing Risks, For Your Business, Scott Nuelle, Recalls, Food Modernization Safety Act, Food Manufacturing