The Food and Drug Administration’s proposed rule on additional traceability requirements for certain foods is more complicated and expensive than it should be.
That’s the gist of 24 pages of comments submitted by the United Fresh Produce Association about the proposed rule, said Jennifer McEntire, vice president of food safety for United Fresh.
McEntire said the work group that United Fresh assembled to look at the proposed rule was very diverse, and inclusive of all the major points in the produce supply chain.
“To boil down 24 pages of comments down to a sentence, this rule is more complicated than it needs to be,” McEntire said.
United Fresh was asking for FDA to recognize opportunities with the proposed rule to simplify the way FDA can get the information it needs.
“At the same time, we recognize that even if this rule was finalized as proposed, it’s not going to solve all the challenges the FDA cites with respect to traceability,” McEntire said.
For example, one complication to the traceability rule is that a large component of any foodborne illness investigation is handled by the Centers for Disease Control and Prevention and not the FDA.
And until the CDC figures out what food is causing illnesses for a particular outbreak, the FDA can’t act.
“So getting to that point takes a lot of time, and until you are there, FDA can’t start their traceback when it’s an outbreak investigation,” she said.
Additionally, it’s possible to maintain accurate records but still have a very complicated supply chain, which sometimes includes co-mingling of product.
“The physical handling practices (of the industry) are not addressed through this rule, and I don’t believe it would be appropriate for FDA to address that,” she said.
“But it is an area where the industry could probably think through the multiple contributors to complex traceability.”
McEntire said there is much redundancy in what the FDA has proposed.
“The more complicated that FDA makes its, the more difficult it is going to be to implement and trace product,” she said.
“It does not have to be complicated as FDA proposed; that’s probably our major comment.”
In general, McEntire said there is industry consensus that the rule needs to be simplified, but not necessarily consensus on what the ideal solution would look like.
One point of contention is how the lot code for produce items gets translated through the supply chain. United Fresh thinks the lot code should be available through the point of sale, and that merely having a purchase order or bill of lading number is not enough. At the same time, maintaining that lot code through the supply chain is a very difficult task to accomplish, and other industry groups are looking at alternative solutions.
In its comments to the FDA, United Fresh said, “We believe that the lot number, tied to the product and accompanied by contact information for the entity responsible for the production (versus distribution) of that product is sufficient to trace products. If some of the information currently proposed to be shared between trading partners were instead required to be tied to the lot number/product and maintained by the entity responsible for creating the lot number (e.g., the originator, creator or transformer), and made available upon written request, we believe that FDA’s objectives could be met at a lower cost to the industry and with improved implementation and compliance.”
The FDA is faced with a November 2022 firm deadline to finalize the rule, so McEntire said it may be unlikely to see the agency open up a second comment period with a revised rule.
“I think it would be a miracle if they could find the time to put out an intermediate supplemental proposed rule, but to the agency’s credit, they have been more communicative and more accessible during this rulemaking process; I can’t think of another rule where they’ve been as accessible,” she said.
“They have offered to continue to listen, continue to observe and hear feedback.”
The FDA has proposed that the final rule would become effective for everyone a little more than two years after it is published.
“That takes us to very early 2025,” she said. “In the United fresh comments, we said that maybe that’s possible. If FDA finalizes a rule, where the requirements are very simple and clear,” she said.
“But as written and proposed, I don’t see that time frame is feasible.”
