Although the Food Safety Modernization Act was signed in early 2011, key parts of the law continue to be finalized by the Food and Drug Administration, the regulatory agency that oversees it.

One of those parts, the FSMA’s Rule 204(d), aka the Food Traceability Rule, is set to be published as a final rule on Nov. 7, and it goes into effect 60 days later. The FDA, however, is giving food companies two years to comply. The FDA cautions that companies not in compliance should not wait because implementing a food traceability program can be complicated. That’s particularly true of food processors/manufacturers, who must discern how their ingredients and product line fits into the FDA’s traceability rules.

This blog from ImEPIK will look at the proposed Food Traceability Rule, specific foods that determine whether food manufacturers must comply, and tips to consider when establishing a traceability program.

What the Proposed Food Traceability Rule Mandates

The rule proposes additional record-keeping requirements for specific foods, which are identified on the Food Traceability List (FTL). Entities that manufacture, process, pack, or hold foods on the FTL must comply, although there are exemptions for small businesses.

The FTL includes leafy greens, soft cheeses, eggs, fresh-cut fruits and vegetables, nut butters, herbs, melons, tomatoes, crustaceans and certain fish, ready-to-eat deli salads, tropical tree fruits, and all varieties of peppers.

The rule calls for companies to establish and maintain records for Key Data Elements (KDEs) associated with what the FDA calls Critical Tracking Events (CTEs).

Those CTEs are:

  • Growing: the first step in the supply chain for fruits and vegetables; sprout growers must keep additional information on KDEs specific to sprouts.
  • Receiving: When a food is received by a customer (other than the end consumer) at a defined location after being transported from another defined location. First receivers, the first person other than a farm who purchases and takes physical possession of a listed food, need to establish additional KDEs. Only foods grown, raised, caught, or harvested can have a first receiver.
  • Creating: Making or producing a food on the traceability list through manufacturing or processing.
  • Transformation: Involves changing a food on the FTL, its package, and/or its label (regarding the traceability lot code). This includes combining ingredients or processing a food by cutting, cooking, commingling, or repacking/repackaging.
  • Shipping: When a food is prepared for transport, such as by truck or ship, from one defined location to another.

Companies who fall under the Food Traceability Rule must establish and maintain records of:

  • A description of relevant reference records
  • A list of foods it ships on the FTL
  • A description of how traceability lot codes are assigned
  • Other information needed to understand the data (such as internal or external coding systems, abbreviations, and glossaries).

Companies that are establishing traceability programs should consider the following items as they work to comply with FSMA.

It’s Time to Update Record-Keeping Systems

food supply chain traceabilityWhile the FDA has noted frustration in dealing with paper records, even hand-written information, in traceback investigations during outbreaks linked to leafy greens, the agency is not forcing companies to use digital records. However, companies must provide the FDA with an electronic sortable spreadsheet of traceability information within 24 hours of a request during an outbreak or other time-sensitive event. The ability to rapidly comply with such a request, whether during a traceback event or an on-site FDA inspection, is worth the expense and eliminates having to assign employees to construct a digital report from paper records.

Choose a Traceability Program That Fits Your Company

Numerous companies are offering traceability software to comply with the FSMA traceability rule. Some systems are tailored to specific industry segments (i.e., growers or manufacturers) or commodity types. For example, Western Growers, which represents members in California, Arizona, and Colorado, offers the Supply Chain Risk Management Solution, which among other things, provides instant case- and item-level traceability using cloud and blockchain-enabled technology.

Test Your Current Traceability Capabilities

The FDA suggests companies be “recall ready” and conduct mock recalls to ensure they can comply with possible FDA requests. Whether through such an exercise or not, companies should be ready to confirm they can quickly and efficiently trace products to where they were shipped from the manufacturing facility. Companies should also do the same for products they purchase, not only by knowing who supplied the product (and when) but by identifying the product’s source.

Know What’s Happening in Your Facility

A food manufacturer’s food safety team should meet by the end of the year to review the traceability rule and the list of foods that require extra record-keeping. If there’s any question of whether a facility’s processes “creates” or “transforms” a food, the FDA should be consulted to see how that particular product affects record-keeping requirements. When the facility adds a new product line or changes ingredients on a product, the FTL should be kept in mind in case an ingredient is listed.

ImEPIK’s Food Safety Training and Traceability

ImEPIK’s food safety training course for Preventive Controls Qualified Individuals offers comprehensive self-paced learning to meet FSMA requirements. The course provides product-specific content for baked goods, produce, dairy, and ready-to-eat foods. In addition, the scenario-based course supports the learning experience with narration, animated videos, sequential content, and the ability to review information missed on assessments.

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