( The Packer )

The Food and Drug Administration’s proposed rule is called “Requirements for Additional Traceability Records for Certain Foods.”

In June last year, the Food and Drug Administration agreed in a consent decree to act by September this year to designate a list of high-risk foods and a proposed record-keeping rule for those same foods. The consent decree was an outcome of a lawsuit filed in 2018 against the FDA by consumer groups Center for Food Safety and the Center for Environmental Health. Those groups said the FDA was in clear violation of complying with the Food Safety Modernization Act mandates in publishing the list of high-risk foods.

The list is here at long last, but there is no mention of “high-risk foods” in the title of the proposed rule. The summary of the 199-page document tries to distill the agency’s efforts.

From the summary:

"The Food and Drug Administration (FDA, the Agency, or we) is proposing to establish additional traceability recordkeeping requirements for persons that manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List. The proposed rule would require these entities to establish and maintain records containing information on critical tracking events in the supply chain for these designated foods, such as growing, shipping, receiving, creating, and transforming the foods. The proposed requirements are intended to help the Agency rapidly and effectively identify recipients of foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death resulting from foods being adulterated or misbranded. We are issuing this proposed rule in accordance with the FDA Food Safety Modernization Act (FSMA)."

The proposed rule will have about a four-month comment period according to the FDA.

So what commodities are on the FDA;s Food Traceability List?

In what the FDA calls a “Tentative Food Traceability List,” the agency lists these items:

  • Cheeses, other than hard cheeses: Iincludes all soft ripened or semi-soft cheeses, and fresh soft cheeses that are made with pasteurized or unpasteurized milk;
  • Shell eggs: Shell egg means the egg of the domesticated chicken;
  • Nut butter: Includes all types of tree nut and peanut butters; does not include soy or seed butters;
  • Cucumbers: Includes all varieties of cucumbers;
  • Herbs (fresh):  Includes all types of herbs, such as parsley, cilantro, basil;
  • Leafy greens: Including fresh-cut leafy greens, includes all types of leafy greens, such as lettuce, (e.g., iceberg, leaf and Romaine lettuces), kale, chicory, watercress, chard, arugula, spinach, pak choi, sorrel, collards, and endive;
  • Melons:  Includes all types of melons, such as cantaloupe, honeydew, and watermelon: 
  • Peppers:  Includes all varieties of peppers;
  • Sprouts: Includes all varieties of sprouts;
  • Tomatoes:  Includes all varieties of tomatoes;
  • Tropical tree fruits Includes all types of tropical tree fruit, such as mango, papaya, mamey, guava, lychee, jackfruit, and starfruit
  • Fruits and Vegetables (fresh-cut): Includes all types of fresh-cut fruits and vegetables;
  • Finfish: Includes all finfish species, such as cod, haddock, Alaska pollack, tuna, mahi mahi, mackerel, grouper, barracuda, and salmon; except does not include siluriformes fish, such as catfish;
  • Crustaceans:  Includes all crustacean species, such as shrimp, crab, lobster, and crayfish;
  • Mollusks, bivalves: Includes all species of bivalve mollusks, such as oysters, clams, and mussels; does not include scallop adductor muscle; and 
  • Ready-to-eat deli salads Includes all types of ready-to-eat deli salads, such as egg salad, potato salad, pasta salad, and seafood salad; does not include meat salads.

Do readers see any surprises with the list? The FDA doesn’t necessarily want to put all the onus on the above commodities. Here is one excerpt from the proposed rule that illustrates their mindset: 

“To realize the full benefits of end-to-end traceability, although the proposed rule applies only to foods on the Food Traceability List, we encourage all firms involved in food production, distribution, and sale to consumers to adopt the recordkeeping practices set forth in the proposed rule for all the foods they manufacture, process, pack, and hold. Consistent with FDA’s “New Era of Smarter Food Safety” initiative (Ref. 21), we will pursue ways to help all supply chain entities adopt practices and technologies that will promote rapid and effective tracking and tracing of foods to prevent or mitigate foodborne illness outbreak.."

The industry has been waiting on this shoe to drop for years. Back in May 23, 2014, I wrote the following in a column for The Packer:

“Is there any way to overcome the distinction of being tabbed by the Food and Drug Administration (FDA) as a “high-risk” food?

Perhaps one fanciful marketing tack to consumers would go something like this: “Sure, our much-loved commodity X is called ‘high risk’ by FDA.

But, it should be pointed out, it is also ‘high reward’ as well. Big-time phytonutrients and vitamins are on board, along with the risk of Salmonella and E. coli bacteria.” I kid, of course.

Having your star-performing fruit or veggie tabbed a “high risk” food is absolutely the worst designation possible for a commodity group or shipper. In that context, I was visiting with one industry leader this week, and he mentioned that the comment period closed May 22 on FDA’s request for industry input on the agency’s methodology for its designation of high-risk foods. In its request for comments, FDA pointed out that the Food Safety Modernization Act (FSMA) requires the designation of high-risk foods.

“Specifically, … FSMA requires FDA to designate high-risk foods for which additional record-keeping requirements are appropriate and necessary to protect the public health,” according to the request for comments.

The law also requires FDA to publish the list of such foods on the agency’s website at the time when FDA issues final rules to establish the additional record-keeping requirements for high-risk foods. So it is a double whammy. Yes, you are a high-risk food! And, yes, you have extra record-keeping requirements!

Former FDA official David Acheson, president and chief executive officer of Frankfort, IL-based The Acheson Group LLC, said in February that the biggest challenge FDA may face is the question of whether a high-risk food can ever be classified as a low-risk food. “Can you get fresh produce, or certain aspects of fresh produce, from a high-risk (list) to a lower risk?” he asked. “That’s part of the challenge.”

No one in the food industry, including fresh produce, wants their commodity to be on the list of high-risk foods. FDA plans to publish the list either before or at the same time it issues a proposed rule establishing record-keeping requirements for designated high-risk foods. FDA’s draft approach to identifying high-risk foods uses several criteria to determine a total risk score, according to the notice. However, no commodities were identified as high-risk in FDA’s initial document.

Some of the factors that FDA will weigh as it determines which foods are high-risk include outbreak frequency, illness occurrence, severity of illness, the likelihood of microbial or chemical contamination, potential for the food to support pathogen growth, food consumption patterns and the probability of contamination and steps taken during manufacturing to reduce contamination. FDA also will look at health and economic factors, cost of illness and disabilities expected, according to the notice.”

TK: If the other shoe has dropped, it is only a soft thud. I think the industry is motivated and can handle all this proposed rule will throw at them. More on what the proposed rule’s traceability requirements are found in Chris Koger's coverage in The Packer.