This is not the only input the FDA is taking on food traceability, but I wouldn't discount its importance. Note the exactitude required for repacking in the recommendations below.

The Institute of Food Technologists (IFT) recommends to FDA steps for improving the ability to trace food products in commercial distribution in the United States: From the IFT Summary.

Recommendations - Required Key Data Elements

Upon request during a traceback investigation, the following data elements should be made available to the FDA by the applicable supply chain partners (from farm to the retail/foodservice outlet). The nature of the key data elements is such that linkages are maintained, allowing a product to be traced through the supply chain. For example, each time a lot number is changed, the original and resulting lot numbers must be recorded. Similarly, if a lot number is unchanged, but the product moves between facilities, this information must be recorded so that the path of the product can be followed. The key data elements that
should be provided in an electronic form using an approved standardized format, for each case containing a product of interest include:

  •  Physical location that last handled the product, whether the manufacturer or not, and, if applicable, contact information for the broker who handled the transaction
  • Incoming lot numbers of product received
  • Amount of product manufactured or shipped
  • Each physical location where cases were shipped (including individual retail and foodservice locations)
  • Lot number(s) shipped to each location
  • When (date/time) product was received and/or shipped
  • For producers, processors, repackers, and others who transform products:
  • When (date/time) each lot was manufactured (or harvested)
  • All ingredients used in the manufacture of the product, along with their corresponding lot numbers (not item code), the immediate source of the ingredients, and when they were received.

As a best practice, the lot number and name of the manufacturing facility should appear on each case of product, and the lot number(s), quantity and shipping location should appear on invoices and bills of lading.

1. Recordkeeping

Each facility handling a product must record its specific transactional portion of the information specified in #1, above, for each Critical Tracking Event. Critical Tracking Events (CTEs) are those instances where product is moved between premises, is transformed, or is otherwise determined to be a point where data capture is necessary to trace a product. The information recorded at CTEs provides the links within the product supply chain.

 Neglecting to capture appropriate data elements at a CTE will result in a break in the product tracing chain, since CTEs capture changes in information, such as changes in lot numbers,that provide the link between products within a product pathway. With regard to product transformation, information captured at those CTEs must be able to accurately match ingredients or incoming material, at the lot level, to outgoing product. Each lot number of each case of shipped product should be recorded, even if “first in, first out” practice (FIFO) is adhered to. Records should be maintained for two years or the shelf life of the product, whichever is longer.

Each entity must provide this information to FDA, as requested, in an electronic format within 24 hours; however, the way in which each firm captures and records data internally is not prescribed. A facility may choose to maintain the key data elements for each CTE in a centralized system or may silo the information according to the CTE. For example, key data elements for receipt of material may be maintained in a system dedicated to receiving while recording the use of ingredients may be maintained in a batching system. Keeping the key data elements separate for different points in a process does not affect a firms responsibility to capture the key data elements that link products through the supply chain.

Internal Product Tracing

The ability to trace products internally accurately must be maintained by food companies. For products that do not undergo further processing or transformation (e.g., the case is not opened) a one-to-one relationship between incoming and outgoing lots must be maintained. For example, if a pallet contains cases with different lot numbers, those cases will need to be followed individually through a system. Incoming lot numbers are one of the key data elements that need to be captured and made available to FDA in an electronic form within 24 hours of an official request.

From a practical standpoint, recording each lot number of each case may require additional labor and slow operations. Since this information should also be printed on paperwork that accompanies or is related to the product, examining lot numbers in a pallet should be done as verification. Mechanisms exist whereby a pallet label can readily communicate the information for each case without the need to record information from every case.

If a pallet comprised of cases with different lot numbers is divided into individual cases, simply providing the various locations that received cases from the pallet (e.g., the recipients), without indicating which lot was shipped to each location, results in a loss in the ability to trace product. In the case of a mixed pallet, shipping records must show where the cases were sent according to the lot number on the case. Lot numbers should also appear on the invoice, bill of lading
and/or purchase order or other accompanying or related paperwork.

 When minimal repacking occurs for perishable products (e.g., to remove items that spoiled prematurely or are otherwise defective), a one-to-one lot ratio should be maintained. In other words, if there is a 5% defect rate, 100 cases of lot “a” should become 95 cases of lot “a”, instead of generating 100 cases of a new lot that are “mostly “a” with a little “b”.

2. Approved Standardized Formats


There needs to be agreed-upon nomenclature and standardized ways of expressing information (for example, dates should be expressed in a single format, not 1/3/09 in some instances and January 3, 2009 in others). For each element above (quantity, location, lot number, date, etc.) there are multiple globally recognized standards; however, in many parts of the food industry, these standards are not used. For each data element, a limited, select set of standards will need to be identified as acceptable
ways to communicate information.

3. Electronic vs. Paper


Access to information in a timely fashion, when requested, is best facilitated by data being available in an electronic format. For operations not currently using electronic databases or other electronic systems, who wish to continue using a paper-based system, the transfer of data to an electronic format should be required. This transfer may be done through third parties, but would be required to be done regularly, such as daily, to be kept current.

4. Required Audit

The ability to trace product should be part of a standard third party audit, so that the correct capture of the data elements specified can be determined. The appropriate identification of CTEs, and adherence to accurate internal tracing should also be assessed.

5. Training


Guidance should be developed that details how CTEs should be identified, and provides definitions for terms such as “lot”. Educational product tracing compliance modules should be developed and all segments of the food industry and regulatory community should be trained in their use.

Core Recommendations

Each supply chain partner must:

• Identify Critical Tracking Events in order to trace product

• Record standardized key data elements for each Critical Tracking Event that link incoming with outgoing product, whether product is transformed (internal traceability) or changes location (external traceability)

• Provide FDA with key data elements in an electronic form for each Critical Tracking Event within 24 hours of a request Standardized ways of expressing key data elements should be agreed upon Education on Critical Tracking Events and key data elements should be developed, and evidence of appropriate implementation should be part of standard audits