FDA Adds New Rules Aimed at Enhancing Food Safety

To date, seven major rules have been finalized by the FDA. The most recent is the food traceability final rule, known as Requirements for Additional Traceability Records for Certain Foods. The list identifies high-risk foods that require additional records to be kept due to their potential to cause a public health issue.

“The proposed changes for the new rule are beneficial not only from the consumer standpoint, but also for the user(s) of the ingredients,” says Adam Richards, food safety engineer at Gray Solutions, a Gray company. “This new rule will require additional record keeping, or further enhancing current procedures to include the required changes.”

Traceability is not a new concept, to be sure. Many food & beverage processors already have traceability requirements in place that exceed FSMA requirements, because FSMA is a floor, not a ceiling. But with the new final rule coming online over the next few years, now is the time for processors to ensure they are meeting — if not exceeding — the FSMA requirements.

“The purpose behind FSMA is to reinforce the food safety system and help mitigate the risks of potential food safety issues,” says Tyler Cundiff, president of Gray’s Food & Beverage Group. “The FDA has made significant strides over the past few years to simplify FSMA protocols into some basic rules; however, the breadth of the overall FSMA program is vast and can be a challenge to digest and implement.”

High-risk foods

The Food Traceability List (FTL) is the FDA’s comprehensive list of foods that require additional recordkeeping to ensure they can be tracked throughout the supply chain. The list was developed with a risk-ranking model that identified chemical and microbiological hazards associated with specific foods, as well as their likelihood of occurring.

According to the FDA, the risk-ranking model considered these factors:

• Frequency of outbreaks and occurrences of illnesses
• Severity of illness
• Likelihood of contamination
• The potential for pathogen growth, with consideration of shelf life
• Manufacturing process contamination probability and industry-wide intervention
• Consumption rate and amount consumed
• Cost of illness

With those factors as the guidelines for determining which foods should be placed on the FTL, the following list was developed:

• Cheeses
• Shell eggs
• Nut butter
• Cucumbers
• Fresh herbs
• Leafy greens
• Melons
• Peppers
• Sprouts
• Tomatoes
• Tropical tree fruits
• Fruits & vegetables (fresh cut)
• Finfish
• Crustaceans
• Mollusks/bivalves
• Ready-to-eat deli salads

The requirements

The foods on the FTL are well-known as potential culprits for foodborne illness outbreaks, and most processors already have a plan in place for how to handle them. But as with any ingredient, there are always concerns about supply chain integrity and how ingredients are handled before they come in the door to ensure they are safe.

Currently, processors who are covered by FSMA already must have a process in place to document “one step forward, one step back” for food and ingredients, meaning they must be able to provide traceability documentation for materials from their direct suppliers and for customers they ship food to. The final rule implements a more robust tracking system at each step of the supply chain, by identifying a number of Critical Tracking Events, which require specific documentation. These events are:

• Cooling (before initial packing)
• Initial packing of a raw agricultural commodity other than a food obtained from a fishing vessel
• First land-based receiving of a food obtained from a fishing vessel
• Shipping
• Receiving
• Transformation of the food

At each of these steps, suppliers and processors are required to document harvesting, storage, and packaging of the products. For seafood from a fishing vessel, a lot code must be established as well as a harvest date and location range.

Among the information required is a Traceability Lot Code, which must stay the same throughout the supply chain. The lot code must be established by suppliers and processors that grow, process, or create food on the FTL. Location identifiers and descriptions must be recorded for each previous source and include receiving address, date, and time of receipt.

“Our food safety and process engineering experts at Gray have really embraced the challenge of recent FSMA changes and, as a result, we are helping our food & beverage customers to understand and implement the necessary programs to help keep the world’s food safe,” says Cundiff.

The practical effects

As previously mentioned, traceability is not a new concept. But even processors who have robust traceability programs currently in place must ensure they are in compliance with the final rule. Doing so has the potential to affect every aspect of operations, not just shipping and receiving.

The first step is reviewing your existing plan to see if it meets the requirements, says Richards.

“When completing trace exercises, pay special attention to the requirements for lot numbers of ingredients and when those lot numbers should change,” says Richards. “If two similar  ingredients with different lot numbers are combined, this will require a new lot number along with traceability for the original lot numbers.”

If the existing plan does not meet the requirements of the final rule, then the FDA website includes information on the Critical Tracking Events and Key Data Elements required. Processors can also check the FDA website for a questionnaire to help them understand what, if any, exemptions apply.

Regardless of whether your current plan is sufficient or if it needs to be shored up, processors must understand the diligence required in record-keeping and tracking materials as they come into the plant and leave as finished products. It’s not just a loading-dock concern; it’s a priority for every part of the operation, says Richards.

“The final rule will impact the customer’s entire process,” he says. “Not only will each item produced require a lot number, but they will also require all affiliated documentation for each lot number to be readily available — within 24 hours — should the FDA request. During the construction phase, it will be important to ensure sufficient infrastructure is in place from an IT perspective so our customers can track their products throughout their process and maintain those records electronically for ease of use.”