How do you quantify the advantages and disadvantages of increased traceability regulations for fresh produce (and other food)?
The Food and Drug Administration, in its proposed traceability rule (Requirements for Additional Traceability Records for Certain Foods), offers two scenarios to answer that question.
The FDA said that the costs of the enhanced traceability regulations under option one (which would exclude retailers with fewer than 10 full time equivalent employees) and option two are $411 million and $535 million, respectively.
The benefits are more, of course, pegged at $567 million for option one and $625 million for option two. Both benefit calculations figure an estimated scenario of 84% traceback time improvement. Additional potential benefits, the FDA said, include increased food supply system efficiencies; more expedient initiation and completion of recalls; avoidance of costs due to unnecessary preventive actions; and other efficiencies from a standardized approach to traceability.
I recently asked a similar question speaking to costs and benefits of the traceability regulations to 14 produce safety professionals as part of a survey to help flesh out stories in The Packer’s Food Safety Section.
The question I posed was this: What could be the advantages and drawbacks of further FDA regulations on traceability?
This question and its responses were not a part of the printed section, but I wanted to give readers these perceptive insights from leading industry professionals. No attribution in this case, but I hope you enjoy these thoughtful replies.
On the advantages and drawbacks:
- “One hope is that it supports a transition to farm digitization and record-keeping, as a regulatory requirement, perhaps this is not just the compliance “stick”, but there can be government incentives or “carrots” for early adopters or organizations that support farm transition. Besides the obvious advantage to shortening recall periods. Drawbacks: Any commodity-specific lists are cause for concern and question, and create market confusion. I also see this as a top-down requirement, rather than active collaboration by FDA to more swiftly communicate with industry and more frequently as outbreaks occur.
- “The more regulations we have the more we can organize and benefit from traceability outcomes such as improving recalls and food safety. On the other side, further regulations might increase the stress in terms of time-consuming documentation and updates. In addition to logistics challenges for trade mainly in developing countries.”
- “We can easily get too granular and create a mountain of data that might actually hinder, i.e. get in the way during food emergencies such as outbreaks. The added burden on both private industry and government agencies could be wasted on foods that have little or no histories of problems and which current guidelines might adequately suffice.”
- “I believe that there are tremendous advantages to improvements in the ability to trace product -- particularly in what is often referred to as the ‘last mile’ before the product reaches a consumer. Not only are improvements in traceability critical to saving lives, but they would also reduce financial impacts throughout the supply chain when an outbreak occurs.”
- “The LGMA has been encouraged by the work done in cooperation with several industry groups as part of the Leafy Greens Traceability Pilot. We urge this kind of cooperation to continue and we pledge our support. We’re hopeful the FDA will utilize information gathered from this pilot to improve investigations and quickly identify the source of outbreaks. All of us are working toward the same goal -- to protect consumers.”
- “FDA’s current draft on Traceability is a step in the right direction, but their blatant overconfidence in what they think they know and business reality is still quite disjointed.
- “The biggest issue in traceback is from the consumer back to the point of purchase for the traceback to be implemented. The initial traceback usually does not begin until about 14 days after the product was consumed. By then in the packaging material that had the lot code has long been separated from the product. At that point it is difficult for someone to recall what was consumed when and what products and even where procured.”
- “Advantages: reduction of waste, identifying sources of outbreaks quickly is an obvious. “
- “Disadvantages: personally, I don’t see any - most are afraid of the govt using their information against them.”
- “The drawback of the currently proposed regulation for additional traceability record keeping is the increased financial burden pushed down to the grower. There is an unnecessary excess redundancy in the proposed regulation that requires information not only to be kept, but to be passed on. FDA appears to have written the rule based on what is more convenient for them without an added benefit of expediency in the tracing process.”
- “Traceability regulations need to create a framework which allows organizations to build systems to quickly and accurately identify and remove problematic products from the supply chain, while not being so intrusive that they reduce the efficiencies within the chain. Traceability systems are powerful tools which businesses use to streamline their supply and distribution networks.”
- “Improved traceability will have very limited impact on reducing food safety risk. Increased bureaucracy and highly prescriptive regulations, potentially developed by individuals with limited or no practical knowledge, may move resources away from investment in actual food safety preventive controls, better training, and other system improvements. “
- “Anything that enhances traceability across the supply chain is a good thing. The drawbacks are always in implementation”
- “Large organizations have an advantage in implementing the traceability requirements that smaller businesses do not. Large retailers are always the first to request their suppliers adopt these regulations. This effectively eliminates smaller and seasonal suppliers from capturing their business.”
- “Advantage would be more visibility for FDA, especially during times of outbreak. Increased reaction times mean fewer illnesses and fatalities. The drawback would be the cost to implement such measures, for the smaller companies, this could be devastating.”
- “The industry has invested significantly into traceability, now we need to see that we can actually use it to both remove questionable items from commerce and to have FDA use it to minimize the $$ impact of outbreaks. The way the three outbreaks at the end of last year clearly show that there are lots of opportunities to deepen public-private partnerships.”
- “I believe taking a long look at the successes and the failures and melding those together will determine the best way the FDA can move forward for the safety of fresh grown produce and what next steps need to be made.”
