The FDA docket on Product Tracing Systems for Food closed March 4, and I will reprint some of the comments from stakeholders in this space. Here are the comments about traceability from the Florida Fruit & Vegetable Association. Particularly note question 5a: What information in a tracing system should be standardized?  That is indeed the unanswered question.

February 26, 2010

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane; Room 1061
Rockville, MD  20852

RE:    Comments on Product Tracing Systems for Food
    Docket Control Number FDA-2009-N-0523

To Whom It May Concern:

This communiqué is being provided in response to the FDA’s announcement requesting input on questions posed relating to product tracing systems for food and the subsequent opening of the comment period, as outlined in the November 3, 2009 Federal Register Notice.  The Florida Fruit and Vegetable Association (FFVA) is a private, non-profit agricultural cooperative whose mission is to enhance the business and competitive environment for producing fruits, vegetables, and other crops by managing issues and providing collective services for our members.  FFVA is submitting this particular set of comments on behalf of our producer members.  We appreciate and welcome the opportunity to supply the Administration with input on this important topic.

The comments contained herein are intended to be constructive and assist the FDA in refining any proposals involving traceability systems.  The Florida specialty crop production industries have had extended histories with traceability and traceability systems.  Traceability and traceability system design/management processes thus far have been both lengthy and exhaustive from the perspectives of all those involved in the production and handling of fruit and vegetable crops in the state.  Standardization of any kind is difficult because of the fact that different commodities are grown, handled, packed and shipped using different methodologies, and seasonality differences, cultural practice differences, etc. compound the challenges of devising any type of standard traceability system.

FDA is soliciting comments and data on a variety of issues related to product tracing systems.  We consulted with a number of our members who are affiliated with our Marketing and International Trade Committee, and the comments contained herein represent consolidation/consensus responses to questions posed by FDA.  Questions and pertinent responses to FDA’s questions are as follows:

Question 1a – Should a lot or code number be assigned to food commodities?  If so at what stage or stages in the supply chain should it be assigned or modified?
Lot or batch numbers should be assigned to all food commodities, and initially done so at the field production level.  However when a food is “manipulated”, a new lot or batch number should be assigned with records showing “superseded” lot or batch numbers.  Modification of the lot numbers should not be done unless the product is repacked or reprocessed outside of the grower’s control after being sold.  Lot configuration should be the prerogative of the grower/shipper to define, as most already have an existing proprietary system in place.

Question 1b – What information would be useful to include in a lot or code number?

Information such as farm/field location and harvest date were included by responders as being potential pieces of useful information.  Further usefulness could be experienced on the part of the producer as well as those utilizing the tracing system itself.

Question 1c – What procedures should be used to establish a lot or code number?  Should any such procedures address the size of the lot or the timeframe for production?
Lot or code numbers should be specific for each individual grower/shipper.  The construction of the lot or batch number format should be the prerogative of the grower/shipper, but most believe the codes should be established from the harvesting date and from the field from which the harvest took place.  Best practices would dictate that lot or batch numbers not cross date boundaries, otherwise they could be sliced and diced based on the grower’s/shipper’s desires.

Question 1e – Should a lot or code number be located:
On the label?  Yes if possible.
On the shipping container?  If practical without adding inordinate costs.

Question 1f – What ways might the lot or code number be linked to internal and external records associated with food commodities?
Responses here indicate that from an internal standpoint, production or quality control records and inventory management systems could possibly be utilized.  From the external perspective, possibly customer invoices or bills of lading could be used for linking.

Question 2a – Should a shipment identifier (ex. invoice number, bill of lading, etc.) be considered an information element of a tracing system?  If so, are there any business practices that would be impacted?
Bill of lading numbers should be an element of a tracing system because where the product was shipped and the amount of the shipment will need to be known, and theoretically this should not have too much of an impact on businesses that already have the proper inventory management systems in place.  

Question 3a – Should product tracing information not currently required to be on the package/shipping case be present on the case?
If the lot or batch information were on the case it should give the supplier/receiver the necessary information to effectively trace back product within a certain timeframe.  The code needs to be as simple as possible but still achieve trace back.

Question 4a – Should some information (identification of the name and location of the farm and packer) be sent forward farther than one step in the chain?  Why or why not, and how far in the supply chain should such information go?
The grower information does not need to be identified, however the shipper contact information still should be included.  If the one-step forward one-step back system were implemented and monitored effectively now, no additional requirements would be necessary.  A shipper only knows the location the load is being sent to; if it is being sent to a broker the original shipper has no way of knowing where it goes from there.  If the product goes to a chain, it goes to the distribution center and they decide where it goes according to their orders, which based on a variety of factors can change at anytime.

Question 5a – What information in a tracing system should be standardized?  (are there specific information elements such as shipment and lot/code numbers that are particularly amenable to standardization?)
The only agreement for standardization at this point seems to be GTIN, but some people are still even resisting that.  Buyer demand could possibly change that issue.  Many question how else this could possibly work, but it is still better for industry to find solutions rather than to have regulations imposed, considering the intricacies and variability of the commodities and between the commodities.  The standardized element should be the brand owner’s GTIN, which could incorporate specifics such as the harvest location and date, the packing/shipping date, and information on which line is processing/packing if there’s more than one line working.  Lot numbers or batch codes should not be standardized.

Question 5b – What standards already exist in your systems and how useful are they for product tracing?
In many existing systems some use a pallet tag tracking system that ties all product information to the pallet from the time it is palletized until it is shipped.  All shipping records contain the pertinent product trace information that is tied to a customer’s shipment (BOL/invoice number).  The pallet tag and that information is placed on the manifest so that if there is a problem a simple investigation will reveal what lot and grower the product came from.  Some already have mock recall systems in place to continually test their systems while simultaneously allowing effective, complete trace back within a matter of hours if it should be necessary.

Question 5c – If standards should be used for certain information elements in tracing systems, should FDA develop the standards?
No, standards should be developed by the industry and sanctioned by FDA.  FDA should establish the necessary elements and the producers should develop the standards.

Question 6a – Would it be useful for persons, in addition to those who produce or pack food, to establish and maintain a record of a lot/code number?  If so, for which persons (distributors, retailers, etc.) would it be useful?
It would be useful for all handlers in the supply chain to maintain a record of all lot numbers/batch codes that are received and shipped.  All brokers and distribution centers should have the information as to where a certain lot went.

Question 7a – Would it be useful for those who produce or pack food to establish and maintain additional information to facilitate linkage (i.e., maintaining linking/sourcing records to link specific lots)?
If the proper systems are setup to provide effective trace back capabilities, this “linkage” should already be available.

Question 8 – Should tracing records be established and maintained in electronic form, and should they also be human readable?
Electronic would be the preference, if possible, but some in the supply chain may not have the capacity, so human readable will still be necessary as well.

Question 9a – What should be done to speed the process of getting the traceback information from those who have it to FDA?
Upon request the information could be sent electronically to the FDA.  Without standardization, data mining is cumbersome for FDA and subsequently the FDA must rely on interpretation of the information from the entity that generated it.  Grower/shippers understand that the faster/better they can isolate a particular lot if it might be implicated in an incident, the quicker a potential problem is contained and the more favorable the outcome.  Everyone knows that when the FDA/CDC needs to pin down a problem that it helps to have everything in similar format so it doesn’t take them forever via intervention.

Question 10 – Should any enhancement to current product tracing systems apply regardless of risk, or should enhancements be based on risk?  What criteria should be used to determine risk?
Enhancements should be based on the complexities of the industry’s production processes.  A hazard analysis plan would determine the associated risks.  Risk-based enhancements should be required based on history and likelihood of a problem.

Questions 11a and 11b – What are the costs, benefits and feasibility of implementing an enhanced tracing system, and to what extent would an enhanced tracing system affect current business practices, and what would be the cost of any such changes in current business practices for each link in the supply chain?
Costs/benefits projections are all over the board.  For growers, packers and shippers, the cost will vary on the specific type of commodity and at which touch point any labeling of the product is required to be applied.  This cost could be significant.  For subsequent handlers, the cost of scanning and recording product tracing information could be very large depending on current capabilities.  Exact cost requirements, however, are unknown at this point.  Benefits are that in a recall event the scope of the amount of product recalled could possibly be reduced.

Question 11f – What determines the size of a lot and how do lot sizes vary by producer?
No standards exist with respect to the size of a lot or batch of product; they vary by producer.  Lot sizes often are determined by the size of the planting and the planting lots that coincide with dates.

Question 12a – What additional outreach from FDA would better enable producers and packers to comply with the requirements to maintain records of lot/code numbers?
Once the industry settles on tracing system standardization, the FDA should mandate that all parties must comply.

Agricultural production, handling, processing, shipping and marketing practices undergo constant change, and farming has always had very different operational realities and economic pressures than businesses and manufacturing.  In order for Florida’s specialty crop production industries to stay competitive and viable, successful capabilities and capacities respective of traceability are an absolute must.  These systems must be applicable to all relevant entities throughout each of the production/handling/processing/shipping/marketing/retail chain components, and done so in a manner that is not cost prohibitive or defeating.

We appreciate the opportunity to provide FDA with these comments that will hopefully assist with decision-making relative to traceability and the further incorporation of traceability systems.  If there are any questions concerning these comments or a traceability system’s potential fit in a specialty crop production, handling, processing, shipping or marketing situation, please feel free to contact us at your convenience.  Thank you in advance for your attention to this matter.


Michael J. Aerts
Marketing and Membership Division
Florida Fruit & Vegetable Association