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FDA drops new produce guidance and wants to talk about it

foodsafetynews 2018-12-19
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Call it a little lite winter reading for America’s produce growers and processors.

It’s the 152 pages of non-binding draft guidance titled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Guidance for Industry,” which is paired with the 71-page “Guide to Minimize Food Safety Hazards of Fresh-cut Produce.

“This draft guidance is a much-anticipated milestone in the implementation of the Produce Safety Rule,” explains Dr. Barbara P. Glenn, Chief Executive Officer of the National Association of State Departments of Agriculture (NASDA). “Although guidance is nonbinding, education and inspection programs will now be able to incorporate FDA’s guidance into their efforts to provide better insight for the industry to comply with this complex rule. We appreciate the opportunity to provide comment on the draft guidance and look forward to working with the FDA, as implementation partners, in this process.”

NASDA is the nonpartisan, nonprofit association which represents the elected and appointed commissioners, secretaries, and directors of the departments of agriculture in all fifty states and four U.S. territories. It has a cooperative agreement with FDA to help implement the Produce Safety Rule.

Congress passed the Food Safety Modernization Act in late 2010, and it was signed into law by President Obama on Jan. 4, 2011. The final Produce Safety Rule was published almost three years ago on Nov. 27, 2015.

“We understand that produce safety begins on the farm, but it doesn’t stop there,” said FDA Commissioner Scott Gottlieb. “Everyone in the supply chain, from farm to table and in between, has an important role to play in food safety. Compliance by the produce industry with FSMA’s preventive controls is critical to achieving the public health benefits envisioned by the new law. And the FDA is committed to providing training and other support to farmers and produce processors to help achieve that goal.”

“Toward assisting farmers and processors in achieving these goals, the FDA is releasing two new, draft guidance documents, one of which will help farmers better understand the range of steps they can take to comply with the Produce Safety Rule,” he added. “The other will help processors better understand the relevant provisions of the Preventive Controls Rule for fresh-cut produce that apply to their practices.”

“To accommodate growing practices that vary by region and commodity, flexibility was built into the Produce Safety Rule. That flexibility is reflected in the new draft guidance document,” he said. “The draft guidance for farmers, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Guidance for Industry,” gives examples of possible approaches to comply with the Produce Safety Rule to demonstrate how the rule might be implemented on different kinds of produce farms. It’s important to recognize that not every scenario is covered in the draft guidance, and farmers can always use an alternate approach as long as it satisfies the requirements of the Produce Safety Rule. But farmers can use the draft guidance as a guide to help evaluate their own on-farm practices.”
The FDA commissioner said the agency will hold four, yet-to-be-scheduled public meetings and take public comments on the “guidance documents” through April 22, 2019.

“Stakeholder input and feedback has been a critical part of the FSMA implementation process,” Gottlieb says. ” And we’re committed to hearing all perspectives. Our aim is to ensure that the guidance we put in place will help the industry comply with the new food safety standards and achieve the goal of producing safer produce.”

The last significant action on the Produce Safety Rule occurred a year ago when FDA decided to extend the compliance dates for the agricultural water requirements.  The rule requires growers follow certain testing protocols if growing produce with untreated surface water or untreated groundwater.

For produce other than sprouts, an additional two to four years was added to agricultural water compliance dates. The deadline for small farms was advanced to Jan. 26, 2023 and for very small farms to Jan. 26, 2024. Sprouts did not get an extension because of their vulnerability to contamination.

The deadline extensions, however, did not likely play a role in this year’s E. coli O157: H7 outbreak involving romaine lettuce. Poisoned canal water was a factor in that outbreak, which through June sickened 210 people in 36 states, resulting in five deaths.

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