FDA, Food Industry Must Act to Improve Product Traceability

The Food and Drug Administration and other public health agencies started working in mid-April to pinpoint where and how dangerous E. coli bacteria contaminated romaine lettuce, ultimately causing at least 210 illnesses and five deaths across 36 states.

FDA and the Centers for Disease Control and Prevention recently announced that the outbreak was over, and that the culprit strain of E. coli had been found in water taken from a canal in the Yuma, Arizona, growing region. The episode again demonstrated the need to improve the traceability of products to identify the contaminated food item as quickly as possible and limit the number of people who get sick.

FDA continues to investigate how the lettuce—and the canal water—became contaminated. By completing what is known as a root cause analysis of the outbreak (also called an environment assessment), the agency should be able to determine what went wrong and implement measures that could prevent this from happening again.

Officials have described the investigation as challenging for a number of reasons, including the fact that their ability to trace lettuce back to a specific farm has been hampered by inadequate record keeping. In many instances, investigators have had to sift through hundreds of paper invoices; in others, they have found gaps in critical records. This is a time-intensive process of collecting and examining records from multiple businesses; the quality, format, and even the language of various companies’ data can vary, and handwritten paperwork is not uncommon.

Traceback becomes even more difficult because a single production lot of bagged salad may contain romaine from multiple ranches. Better record keeping at businesses producing and distributing the nation’s food would increase the speed and effectiveness of outbreak investigations and recalls of unsafe items. FDA can and should help spur these improvements.

In a 2011 law, the FDA Food Safety Modernization Act (FSMA), Congress directed the agency to establish product traceability requirements for businesses that would protect public health and to designate high-risk foods that warrant additional record keeping. Seven years later, neither task is complete. On May 24, The Pew Charitable Trusts and eight other groups urged the agency to issue these requirements as soon as possible and to place fresh produce, including leafy greens, in the high-risk category.

The challenges can multiply when tracing fresh fruits and vegetables. Businesses typically do not identify the specific farms where these items were grown, and produce from different growers can be commingled along the supply chain.

Existing technologies could help companies and government agencies more rapidly access data crucial to tracking foods implicated in disease outbreaks and subject to recalls. For instance, standardized information about a product’s origins could be provided through machine-readable optical labels, such quick response, or QR, codes on its packaging.

Other voluntary, industry-led programs could improve traceback. For example, the Produce Traceability Initiative has worked with many growers, harvesters, and other businesses on data and electronic labeling standards for fruits and vegetables.

Implementation of fast and accurate food traceability systems across thousands of businesses will take time and cooperation among industry and regulatory agencies. FDA needs to provide leadership on this issue and move forward with aspects of FSMA’s traceability provisions that improve foodborne outbreak investigations and product recalls.

Enhanced capacity to trace contaminated food to its source will give government agencies and companies greater opportunities to learn where past problems began and how prevention-based food safety systems can reduce these hazards and better protect consumers’ health.

Sandra Eskin directs The Pew Charitable Trusts’ work on food safety.