The FDA announced late March that it intends to exercise enforcement discretion for the requirements of the Produce Safety Rule as they apply to entities growing, harvesting, packing, and holding wine grapes, hops, pulse crops, and almonds.
The Produce Safety Rule establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables for human consumption. The rule does not apply to produce that is considered to be rarely consumed raw (RCR), grown for personal or on-farm consumption, or not a raw agricultural commodity. Commodities considered to be RCR are those that the FDA has determined are typically cooked before consumption. Produce that is otherwise covered by the rule may still be eligible for an exemption if it undergoes commercial processing that adequately reduces the presence of pathogens and certain recordkeeping and documentation requirements are satisfied.
After the Produce Safety Rule was finalized, FDA received feedback from stakeholders that wine grapes, hops, pulses, and almonds should be exempt. After conducting an initial review of the production and use of these commodities, the agency decided to exercise enforcement discretion with respect to the Produce Safety Rule for entities growing, harvesting, packing, or holding these commodities while it considers pursuing rulemaking to address the unique circumstances they each present. FDA will continue to enforce the statutory prohibition against introduction or delivery for introduction of adulterated food into interstate commerce.
The guidance for industry represents the current thinking of FDA on entities handling hops, wine grapes, pulse crops, and almonds. Guidances describe the agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
Download the guidance for industry HERE.