Regulatory Requirements for Traceability - The Blytheco Blog
Regulatory Requirements for Traceability

Regulatory Requirements for Traceability


What’s happening today versus tomorrow, and what the FDA can and can’t do

In my first blog post in this series, we discussed what different stakeholders mean when they talk about traceability. From the FDA’s perspective, product tracing is all about getting to the bottom of outbreak investigations fast.

In order to do this, the Agency needs to rely on records created and maintained by the food industry. By following the information in these records and linking it up with the information provided by other supply chain members, the regulators (both FDA as well as state and local officials) can see where the paths of different products intersect—did they share a common warehouse, were they manufactured at the same time, etc.

It was only in 2002 that Congress gave the FDA the authority to require that industry members keep certain records for the purpose of traceability. Before that time, companies typically did so anyway, in large part because knowing what they received and what they shipped is related to their bottom line. But the regulations that stemmed from the 2002 law laid out some specific requirements that went into effect in 2005, and remain in effect today.

The pieces of information that need to be provided to FDA vary slightly depending on the firm’s role in the supply chain. Current record-keeping requirements specify that all firms that manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States (with a few exceptions) must provide the following information on request:

  • Name, address, telephone number and, if available, fax number, and e-mail address of the immediate previous source and subsequent recipient;
  • Adequate description of the product;
  • Date received or released;
  • For persons who manufacture, process, or pack food, the lot or code number or other identifier;
  • Quantity and how the food is packaged; and
  • Name, address, telephone number and, if available, fax number, and e-mail address of the transporter who transported the food to and from you.

Firms are free to keep this information in whatever format is convenient for them—the information doesn’t need to be kept electronically, it just needs to be provided to the FDA within 24 hours of a request.

But the format of the data does matter. It’s extremely difficult to try to match up records, even though the regulations suggest that there should be redundancy to the system. As a result, Congress charged the FDA with identifying ways to make product tracing more efficient, accurate, and effective. Without question technology will play a role.

Although Congress laid out a number of restrictions on the FDA, we expect that the FDA will take the learnings and recommendations from the IFT study that the FDA commissioned when developing the proposed rule, which will have to accommodate the following bounds as per FSMA:

  • Must relate only to information that is reasonably available
  • May not prescribe a specific technology for maintaining records
  • Must ensure that benefits outweigh the cost of compliance
  • Must be scale-appropriate
  • Must minimize the number of different requirements for facilities that handle multiple types of food
  • Must not require, to the extent possible, a facility to change their existing business system
  • Must not require a full pedigree (a record of the full distribution of the food)
  • Must not require firms to track product downstream through the supply chain beyond the immediate recipient
  • Must not require product tracking to the case level

What exactly will the FDA require? Only time will tell, but our prediction is that it won’t be as stringent as where some segments of the industry are already headed.

Stay tuned for the next post, which will talk about what type of traceability requirements your customers may mandate above and beyond what the FDA may ask for.

Jennifer McEntire, Ph.D.

Jennifer McEntire, Ph.D., Vice President and Chief Science Officer for The Acheson Group, former Senior Staff Scientist and Director of Science & Technology Projects at the Institute of Food Technologists.

Avatar for Denise Renee

Share This Post