FSMA Produce Safety Rule

Produce Safety Rule

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, on Nov. 10, 2015. 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 has placed an enforceable implementing regulation which explicitly articulates on-farm standards of conduct for the safe growing, harvesting, packing and holding of fresh produce.  
• Although compliance dates for major portions of the Produce Safety Rule have already passed, certain provisions and definitions remain unresolved. Check back for more information and updates on topics such as agricultural water and ‘farm vs. facility’ definitions.

FDA Resources on the Produce Rule

• Final Produce Rule
• FDA prepared Fact Sheet
• FDA Q&A on facility registration

Additional Review and Resources

Nov. 29, 2022 by Hogan Lovells: FSMA Update: FDA issues final traceability rule for certain foods

Dec. 14, 2022 by Hogan Lovells: Traceability Final Rule, IFPA Virtual Town Hall

Fixing FSMA’s Ag Water Requirements

Read an article on Agricultural Water written by Jennifer McEntire, Ph.D. International Fresh Produce Association, and Jim Gorny, Ph.D., formerly PMA, in Food Safety Magazine’s August/September 2017 edition

UVM Water Testing Labs

Although the FDA’s current ag water rule is being rewritten, grower’s may still wish to test their water to better understand their water source quality or for audit and buyer requirements. The University of Vermont created a map of US Water Testing Laboratories. That map can be found on the UVM website here.

PSA Supplemental Slides for Agricultural Water

This PowerPoint includes a few slides that review the latest FDA announcements regarding the provisions in Subpart E that relate to agricultural water.

Farm vs. Facility

The line for packinghouses and cooling operations is still blurry. Read this co-authored article by Dr. Jennifer McEntire and  Dr. Jim Gorny (formerly with PMA), talking about our proposed solution.

Do farms need to register with FDA? What about their packinghouses? What if they are exporting to the U.S.- don’t they need a registration number?

No, no and no. Farms, including packinghouses that meet the definition of secondary activities farms, are not required to register and should not register with FDA, whether located inside or outside of the U.S. Facilities that manufacture, process, pack and/or hold food (that don’t meet the farm definition) are required to register. FDA has a very comprehensive Q&A on facility registration.

Produce Safety Network

FDA’s Produce Safety Network (PSN) was established to support the efforts of farmers, regulators, and other key stakeholders to implement the rule. The network consists of FDA produce safety experts, located in various locations throughout the country.

•  Produce Safety Network Contact List