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FDA takes 22 days to respond to produce rule questions from the field

Tuesday, November 29, 2016 22:25
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A new U.S. Government Accountability Office (GAO) report for a handful of congressional leaders takes up less than five pages, but appear to include a smoking gun for produce regulations that have become too burdensome.

The U.S. Food and Drug Administration (FDA), the government unit that wrote Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption was found by GAO to be having great difficulty answering questions about the new produce safety rule.

FDA has set up a clearinghouse called the Technical Assistance Network (TAN)  to answer questions from the industry and other stakeholders about all the rules required to enforce the Food Safety Modernization Act (FSMA). It’s been operational since September 2015, taking questions online, by phone, or via traditional mail.

In the first year, TAN took 2,626 questions. The GAO report says about 14 percent pertained to the produce rule and 60 percent of those came from the produce industry and businesses. Many of those questions involved water uses under the produce rule that meets the definition of “agricultural water.”

Others sought in the field guidance for collecting samples of agricultural water, and others that are FDA’s priority topics.

Yet, the agency acknowledges that by October 2016 only 72 percent of the questions were answered.

FDA said because some FSMA rules remain works in progress, it has not wanted to provide answers through TAN that might conflict with “subsequent guidance.” For the questions TAN is answering, the wait is 22 business days. After 30 days without an answer, FDA does send out an automated message that they are working on a response.

GAO interviewed representatives of six produce associations and one large retailer to get feedback from a mix of large, medium and small producers about implementation of the produce rule.

“The produce rule for farmers is so vast and so complex that it’s really not a surprise the agency is slow to respond to more than a quarter of all questions, “ said Josh Rolph, manager of federal policy for the Farm Bureau Federation of California.

In a statement released after the GAO report was issued, Rolph added: “When the agency decided to apply the rule to all produce, regardless of risk, it opened itself up to a messy implementation process. Everyone wants to do what’s right to assure food safety, but the produce rule may stick farmers with another regulatory burden while doing little or nothing to improve the safety of their crops.”

Most California produce growers were complying with the Leafy Green Marketing Agreement, which retailers and growers imposed voluntarily after the 2006 E. coli outbreak involving bagged spinach.

Congress passed the FSMA in 2010 with a rare bipartisan majority. The incoming Trump administration is making regulatory reform a priority, but not yet clear if food safety will be scaled back in anyway.


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  • desertspeaks

    I can’t locate the authority for the FDA in the Constitution, would anyone care to point that out for us?

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