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FDA Announces Enforcement Discretion for Certain Commodities Related to Produce Safety Rule

  • The FSMA final Produce Safety Rule was published on November 27, 2015 (80 FR 74353) and establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce. Our detailed summary of the rule is available here.

  • In a recently released guidance for industry, “Produce Safety Rule: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds,” the Agency announced it will exercise enforcement discretion for Produce Safety Rule requirements for specific commodities: hops, wine grapes, pulse crops and almonds. After receiving input from industry groups and conducting its own analysis, the Agency concluded that these commodities have unique production circumstances and intended uses which reduce the likelihood for foodborne pathogens to pose a risk.

  • Ultimately, this announcement of enforcement discretion means that the Agency will not expect entities growing, harvesting, packing, or holding these commodities to meet any of the Produce Safety Regulation requirements with respect to these commodities. However, in the guidance, the Agency noted that it may consider pursuing rulemaking to address the unique circumstances of each commodity and may revise the exercise of enforcement discretion if, for example, new information becomes available regarding safety concerns associated with the production and consumption of these commodities.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...