|
Click to listen to this article
|
By Claire Murphy, Extension Specialist, Washington State University
The Food Safety Modernization Act (FSMA) was signed into law in 2011 and was the most significant update to U.S. food safety regulations in more than 70 years. Its core goal is to shift the nation’s food system from reacting to contamination to preventing it. FSMA created several major rules, including the Produce Safety Rule, Preventive Controls rules for human and animal food, and the Foreign Supplier Verification Program. Together, these rules require farms, processors, importers and distributors to identify hazards, put preventive measures in place, maintain better records and improve traceability so that contaminated food can be removed from the market more quickly.
The regulations surrounding produce safety are changing, with two major regulatory updates from the U.S. Food and Drug Administration shaping how farms grow, handle, and track fruits and vegetables: the revised Subpart E of the Produce Safety Rule focused on pre-harvest agricultural water and FSMA’s Traceability Rule (Section 204).
Subpart E: Agricultural Water Requirements
Subpart E is the part of the Produce Safety Rule that covers pre-harvest agricultural water – water used for irrigation, frost protection, crop spraying and any other activity that touches the edible portion of the crop before harvest. The original version of Subpart E set microbial quality criteria (generic E. coli indicator levels) and testing schedules for agricultural water. Growers, scientists and regulators all found this approach too rigid and too difficult to implement, especially since water quality can vary widely due to weather, wildlife and regional conditions. The revised Subpart E (final rule published May 6, 2024) shifted away from mandatory routine water testing to requiring farms to complete a Pre-Harvest Agricultural Water Assessment. This assessment helps farms identify risks from (i) the source of the water (surface water, groundwater, etc.), (ii) how the water is applied, (iii) nearby land use that could introduce contamination, (iv) weather conditions, (v) crop characteristics, (vi) water distribution system infrastructure and (vii) history of water testing. This approach recognizes that risk depends on the whole system, not just on a single test result. If the farm identifies risks, it must take action to reduce risks. This type of systems approach recognizes that water safety is context-dependent and gives growers more flexibility to implement targeted mitigations.
FSMA Traceability Rule (FSMA 204)
FSMA 204, also known as the Traceability Rule, focuses on improving how certain foods are tracked through the supply chain. The rule applies to foods on the Food Traceability List (FTL), which includes products with a history of being involved in outbreaks, such as leafy greens, melons, tomatoes and fresh-cut vegetables. Under the rule, businesses must record specific Key Data Elements (KDEs) at Critical Tracking Events (CTEs) – points in the supply chain such as harvest, packing, receiving and shipping. Examples of KDEs include lot numbers, product descriptions, harvest or packing dates, quantities, and the names of the businesses that sent or received the product. The purpose of these requirements is to make it possible to quickly locate and remove contaminated product during a foodborne illness investigation, reducing the number of people who might get sick and limiting unnecessary product loss.
It’s important to note that fresh onions are not currently on the FTL, so technically, onion growers are not covered by FSMA 204. However, many buyers are going to require all suppliers – regardless of whether they are on the FTL – to follow the traceability rule. This is because buyers want consistent records and the ability to track any fresh produce. For growers, this means keeping clear, organized records of lot numbers, harvest dates, packing dates and shipments – even if you don’t yet fall under the official regulation.
The original compliance date for the traceability rule requirements was Jan. 20, 2026. However, the FDA has proposed to extend the compliance date by 30 months to July 20, 2028. This gives the industry additional time to develop recordkeeping systems and coordinate with buyers. The extension also allows regulators sufficient time to provide guidance, clarify expectations and define enforcement procedures before full compliance is required.
Author’s note: Anyone needing guidance on compliance with either the revised Subpart E or the Traceability Rule can contact Claire Murphy, extension specialist at Washington State University’s School of Food Science (claire.murphy@wsu.edu).