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State and federal officials will now have unified federal standards guiding produce inspections under new guidelines being implemented by the Food and Drug Administration.
The FDA has released Produce Regulatory Program Standards meant to ensure uniform fruit and vegetable inspections conducted by both federal and state officials. They lay out requirements for training, inspections, foodborne illness response, and outreach activities for states conducting federal inspections.
"These are really quality standards to ensure that there's consistency and uniformity and how the states are carrying out this work,” said Joe Reardon, senior director of food safety programs for the National Association of State Departments of Agriculture.
Joe Reardon (NASDA photo)The new guidelines are the latest regulatory program standards FDA has issued, with the agency in the past creating such standards for eggs, animal food, manufactured food, and retail food. However, the modern produce inspection system is relatively young historically, with the FDA first issuing its final rule on produce safety in 2016. States generally began conducting inspections in 2019, according to FDA.
Stephen Mandernach, the executive director of the Association of Food and Drug Officials, called the new standards “the logical next step” in FDA’s produce inspection program. Unlike regulatory program standards for other types of foods, he said the relative newness of the agency’s produce standards gave the agency a “clean drawing board” to plan them out.
However, he added that standards tend to evolve over time, so future updates will likely occur as produce inspections evolve.
“Standards evolve over time,” he said. "Things will likely change. That is part of what we would expect to happen."
FDA Commissioner Marty Makary has said 95% of FDA produce inspections are conducted by state agencies. These are done under cooperative agreements, with FDA providing some funding and technical assistance in response. Forty-seven such agreements exist, according to the FDA website.
Implementation of the standards is voluntary, though "states enrolled in program standards under an FDA funding vehicle will be expected to develop and implement improvement plans to demonstrate that they are moving toward full implementation,” the standards say. They will also need to "participate in FDA assessments to determine the level of conformance.”
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So far, nine state programs involved in cooperative agreements with the agency are completing self-assessments to test for compliance with the new rubric and plan to develop strategic improvement plans, according to FDA. The agency also is conducting an internal compliance assessment for its own inspection program.
However, Reardon noted that “these are very resource-intensive standards for the states,” noting the costs of developing procedures, materials and conducting staff training, audits, and improvement plans. He said states are hoping the next batch of cooperative agreements that go into effect in July include funds from FDA targeted towards implementing the standards.
"States are excited about the possibility,” he said of the new standards. "They believe there's value in them. They're supportive of uniformity and consistency that will be derived from these standards. And the consensus of the states is that they do add real value, and they're hoping that FDA will provide the resources so they can implement them."
A FDA page on the new standards notes that “currently, there is no dedicated funding for produce programs to implement” the new standards.
Max Teplitski, chief science officer for the International Fresh Produce Association, told Agri-Pulse he hears concerns from IFPA members about “inconsistent" inspections in different jurisdictions because state requirements and inspector training programs vary. He applauded FDA’s goal of a uniform approach, calling it “a huge positive.”
However, he said some components of the standards lack clarity, like the idea of “risk-based” inspections. He noted that while potential intrusions of wild animals like migratory birds would be seen as a risk, it isn’t clear under the guidelines how the agencies would assess that risk, particularly between produce items that see differing levels of preparation in the kitchen.
"In practice, we've always supported risk-appropriate regulations because some practices are inherently requiring more oversight, additional paperwork, and others are generally considered most straightforward,” Teplitski said. “We need to understand from FDA and from the states what risk-based prioritization means. So that's the number one uncertainty."
