To comply with section 204 of the massive Food Safety and Modernization Act (FSMA), the Food and Drug Administration (FDA) has been working on rulemaking for the traceability of produce including fruits, vegetables and herbs.

A proposed rule was first published in September 2020 and FDA hosted three public meetings about it (virtually). During the initial public comment period, many people and groups expressed concerns and requested additional time to more fully explore the costs and other impacts of the proposal. The public comment period was extended from January to February 2021, which also aligned it with the extended comment period for the related information collection provisions.

The FDA now is scheduled to publish its final rule by Nov. 7, 2022. The foods on FDA's proposed traceability list include fresh cucumbers, herbs, leafy greens, melons, peppers, sprouts, tomatoes and tropical tree fruits. It also includes fresh-cut fruits and vegetables. 

Broadly speaking, the concerns raised in public comments focus on the cost, the technology and the lack of distinction between larger national (or international) distribution streams and small to mid-size local ones. Also, some industry groups feel their members have already demonstrated their commitment to voluntary enhanced traceability efforts so further federal regulation, while required by law, need not exceed what’s already in place.

Ed Treacy, vice president of supply chain and sustainability at the International Fresh Produce Association (IFPA) told Agri-Pulse the produce industry has worked hard to protect public health and prevent what he calls “category killer recalls,” which are events that impact a wide swath of an industry sector rather than the specifically identified links in the chain that might be contaminated. To that end, he says the produce industry “developed a standardized label with a barcode to be attached to every carton of produce when it was packed.”

Treacy said FDA’s proposal largely echoes what IFPA has implemented, though some recordkeeping changes don’t sit well with the industry, including a requirement that the lot number on each box of produce include a contact name for the person who assigned that number. Treacy said often that’s generated by a computer. He also noted FDA wants retail stores to share customer information, such as credit or loyalty card numbers, to corroborate a consumer’s claim of purchasing a product at a certain place on a certain date. Treacy said that data can be confirmed without the retailer having to share it with federal officials.

Despite his concerns about the proposed rule, Treacy said “we're very pleased that it aligns very nicely” with what’s already in place. Like IFPA, California Leafy Greens Marketing Agreement has its own traceability initiative, developed in partnership with FDA.



For smaller operations, though, the rule doesn’t seem to maintain exemptions that should apply. Two farmers operating a small organic farm in Washington state submitted a comment because they fear the new requirements would put some small farms out of business. For example, spreadsheets would need to be available within 24 hours, in the event of an outbreak, documenting where produce was grown and distributed.

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“Food Safety is critically important for both the health and peace of mind of our citizenry, but policies intended to support it must reflect the actual science of foodborne illness and the scale and production and distribution practices of growers and processors,” wrote Mike and Kim Finger of Cedarville Farm. They said their produce is distributed within a small area and they know who buys and when. They don’t want to add additional technology to their operation for recordkeeping they see as unnecessary.

“We don’t need GPS to know where last Tuesday’s lettuce came from,” they wrote, “nor would anything more than a simple harvest log be needed to confirm where a crop came from, when it was picked, and to which buyer it was intended.”

Their concerns reflect those submitted by the National Sustainable Agriculture Coalition

“Small farms with short, local supply chains take huge financial losses when broad recalls prevent their product from getting to market, even though their produce is clearly not implicated in nationwide outbreaks,” NSAC wrote in its comment. Regulations should not be one-size-fits-all, it said, adding that the proposed rule does not respect existing exemptions based on size.

Nobody disputes that FSMA requires FDA to conduct produce traceability rulemaking. In fact, there's broad agreement with the premise of protecting public health by establishing systems for quickly identifying and removing contaminated or potentially contaminated products from the food supply. It may still be months, though, before FDA reveals how it plans to get there.

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