On November 10, 2015 the FDA published the final rule on Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
, commonly called the Produce Rule. The rule applies to fruits and vegetables for human consumption that are raw agricultural commodities, and sets standards for the growing, harvesting, packing and holding of such produce to minimize the risk of serious adverse health consequences or death.
- This regulation affects both international and domestic produce growers, in that it establishes science-based standards focused on the growing, harvesting, packing and holding of produce on-farms.
- The key provision areas include agricultural water quality standards and testing, standards for using raw manure and compost, training, control of domestic and wild animals, equipment, tools, buildings, sanitation as well as worker health and hygiene.
- This on-farm produce safety regulation is significant in that FDA will now put in place an enforceable implementing regulation which explicitly articulates on-farm standards of conduct for the safe growing, harvesting, packing and holding of fresh produce
It’s anticipated the agency will soon be issuing important companion guidance documents for all final FSMA rules that will provide more detailed information about coverage and compliance requirements. There will be an opportunity to provide comments on these upcoming draft guidance documents, so stay tuned.
FSMA Final Produce Rule Summaries
FSMA Final Rule Webinars
PMA hosted a webinar series with allied associations, featuring the FDA.
FDA Resources on the Produce Rule
Exemptions from Produce Rule
Produce that is (1) rarely consumed raw, (2) grown for personal or on-farm consumption, or (3) destined to undergo commercial processing to reduce microorganisms are exempt from these requirements. Very small farms are not covered by the rule, while others would be eligible for a partial exemption, which could be withdrawn due to specified safety concerns.
Produce Rule Compliance Guides
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