FDA announces FSMA enforcement discretion

U.S. Food and Drug Administration

Will exercise discretion for producers of hops, wine grapes, pulse crops and almonds

The U.S. Food and Drug Administration issued a final guidance stating the agency’s intent to exercise enforcement discretion for the requirements of the Produce Safety Rule, part of the Food Safety Modernization Act (FSMA), as they apply to entities growing, harvesting, packing and holding wine grapes, hops, pulses and almonds. This means the agency does not intend to enforce requirements of the rule for farmers and producers of these commodities.



The final guidance, Produce Safety Rule: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops and Almonds, explains that after reviewing data presented on the production of wine grapes, hops, pulses and almonds, the FDA recognized that these commodities have unique production circumstances and intended uses that reduces the presence of foodborne pathogens and may qualify them for an exemption. That’s why the guidance issued today explains that the FDA does not expect entities growing, harvesting, packing or holding these commodities to meet any of the rule’s requirements while the agency considers pursuing rulemaking to address the unique circumstances of these commodities.

It’s important to note that this guidance does not exempt producers from ensuring the safety of their commodities. As we consider rulemaking, the FDA will continue to take action as needed to protect the safety of the U.S. food supply.

“The Food Safety Modernization Act empowered the FDA to enact a more modern, preventive and risk-based approach to food safety with a focus on setting common-sense safety standards for food producers to protect public health. We’ve worked closely with food producers to implement FSMA’s Produce Safety Rule, which for the first time, establishes science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption. As part of this collaborative process, we’ve received important feedback on the application of this rule from stakeholders of certain commodities, including hops, wine grapes, pulse crops and almonds,” said FDA Commissioner Scott Gottlieb, M.D. “In taking this step, we’ve considered the use of unique production processes that reduce the presence of foodborne pathogens. We’re announcing today that we’re not expecting hops, wine grapes, pulse crops and almonds producers to meet the requirements of the rule currently. Given the nature of these specific commodities, and the low risk that these products pose because of the way that they’re processed and consumed, we do not expect producers of these commodities to comply with the Produce Safety Rule. It is always our goal to be as transparent as possible when communicating our expectations to our stakeholders and by working closely with food producers as we continue to implement FSMA, we can help ensure that the U.S. continues to have one of the safest food supplies in the world.”

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