FDA Announces FSMA Tracking Pilots for Produce, Processed Food

FDA has also added information on the tracing pilots and the related recordkeeping requirements for high-risk food to its FSMA frequently asked questions (FAQ) document, along with a new section on food defense. (See ITT’s Online Archives or 09/08/11 news, 11090812, for BP summary of the FAQs on food defense.)

One Pilot Will Focus on Processed Food, the Other on Produce

One pilot will be conducted in coordination with the processed food sector to explore and demonstrate the tracking and tracing of a processed food and a few key ingredients. The other will be conducted with the produce sector to explore and demonstrate tracking and tracing of selected fruits and/or vegetables. Those interested in participating should notify the FDA contact party listed below.

Pilots to Focus on Speed of Communication, Useful Data, Supply Chains

The pilot projects will explore and demonstrate methods for rapid and effective tracking and tracing of food, including the types of data that are useful for tracing, ways to connect the various points in the supply chain and how quickly data can be made available to FDA. FDA states that in general, a product tracing system involves documenting the production and distribution chain of products so that in the case of an outbreak or evidence of contaminated food, a product can be traced back to a common source or forward through distribution channels.

Will Include Mock Tracebacks, Cost-Benefit Analysis, Etc.

In the design and implementation of the pilot projects, IFT will:

• Conduct mock tracebacks - conduct mock tracebacks with a goal of identifying a common source in the supply chain.
• Address whole supply chain, ensure practicality, etc. - ensure that the pilots address the whole supply chain; are practical for facilities of varying sizes; include different types of FDA-regulated foods that have been the subject of significant outbreaks between 2006 and 2010; etc.
• Assess costs & benefits --assess the costs and benefits of the methods for rapid and effective tracking and tracing of the selected foods and key ingredients.
• Consult with agencies, etc. - consult with the U.S. Department of Agriculture, state public health agencies and organizations that represent consumer interests.

Once Pilots Completed, FDA to Initiate Rulemaking on High-Risk Food Recordkeeping

The FSMA also requires FDA to establish recordkeeping requirements for high-risk foods to help in tracing products. After the two pilots are completed and additional data gathered, FDA will initiate rulemaking on recordkeeping requirements for high-risk foods to facilitate tracing.

FDA must define high-risk foods, considering such factors as the known risks of a food based on foodborne illness data, the likelihood that a particular food has a high potential risk for contamination, and the likely severity of an illness attributed to a particular food.

According to FDA, Congress already stipulated that the high-risk food recordkeeping requirements must be science-based, relate only to information that is reasonably available and appropriate, must have public health benefits that outweigh the cost of complying, etc.

FDA Does Not Plan to Recommend Specific Software Systems, Etc.

FDA does not plan to recommend specific software or systems at any of these stages. Rather, FDA will focus on the elements of a product tracing system that enable rapid and effective tracing of food products. Furthermore, FDA is not permitted to prescribe specific technologies to maintain records in the context of the additional recordkeeping requirements for high-risk foods.

FDA contact - Caitlin Hickey (202) 330-4985, chickey@ift.org

FDA FAQs, updated 09/07/11, available here.