Guest Post: FDA Traceability Requirements, Today and Tomorrow

Manufacturing Insights Blog

By Dr. Jennifer McEntire, Senior Director, Leavitt Partners

The questions we’ve fielded on how the FDA will use Sec 204 of The FDA Food Safety Modernization Act (FSMA) to enhance recordkeeping and improve product tracing reveal a lack of understanding of some of the recordkeeping requirements currently in place.

Response Time

Current recordkeeping requirements stem from the 2002 Bioterrorism Act and a 2004 rule published by FDA, which states what information needs to be provided to the FDA within 24 hours of a request. FSMA does not change the timeframe; although in a complex supply chain, multiplying 24 hours by the number of supply chain participants results in unnecessary consumer exposure to hazards, as well as brand and category damage.

One-Up/One-Back Traceability

Today, firms have to provide specific information to the FDA regarding the immediate previous sources of a product as well as the immediate subsequent recipient of a product (other than consumers). They also have to maintain records associated with the use of ingredients in finished products. The law exempts farms and restaurants. This is commonly referred to as the one-up/one-back (or down) requirement. Neither the type of paperwork (e.g., invoice, production record, purchase order, etc.) nor the format (e.g., paper, electronic) is currently specified.

Data Requirements

The pieces of information that need to be provided to the FDA are specified, and they vary slightly depending on the firm’s role in the supply chain. Current recordkeeping 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.

Future Recordkeeping Requirements

The Food Safety Modernization Act will add more specificity to exactly which records a firm needs to keep for “high-risk” foods (yet to be defined) and seeks to further improve the FDA’s ability to track and trace food products in order to protect public health. While a “proposed rule” is not expected before January 2013, there are steps that firms should take — not only in anticipation of future regulations, but to protect their brands and public health. These include considering how data is captured, what data is captured and how technology can be used to aid in recordkeeping to ensure rapid responses, both internally and across the supply chain.

Dr. Jennifer McEntire is Senior Director of Leavitt Partners. She recently led the product tracing pilot studies required by the FSMA, conducted by the Institute of Food Technologists (IFT) for the FDA. The studies included recommendations on traceability improvements. You can also view an on-demand webinar with Dr. McEntire and Dr. David Acheson, Managing Director of Leavitt Partners, on the four steps to improving food tracing - click here to watch the webinar. 



Dr. Jennifer McEntire, Senior Director of Leavitt Partners