By Lowell Randel, Senior Vice President – Government and Legal Affairs at GCCA
The first major regulation under FSMA in years.The first major regulation under FSMA in years.
A proposal to create a new regulation related to food traceability was released by the US Food and Drug Administration (FDA) on September 21, 2020. The rule would be a part of the food safety framework established through the Food Safety Modernisation Act (FSMA) and is authorised by Section 204(d) of the [US] legislation. The effort represents the first new major regulation under FSMA in several years.
The regulation also furthers the agency’s effort to advance the FDA’s New Era of Smarter Food Safety Blueprint. According to the FDA, the regulation would help the agency rapidly and effectively identify recipients of higher risk foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death.
At the core of the proposal is a requirement for those who manufacture, process, pack or hold foods on the Food Traceability List (FTL) to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs). While the proposed requirements would only apply to those foods on the FTL, they are designed to be suitable for all FDA-regulated food products and FDA encourages voluntary adoption of these practices industry-wide.
The proposed regulation would add new traceability recordkeeping requirements (beyond what is already required in existing regulations) for persons who manufacture, process, pack, or hold foods that have been identified on a newly proposed FTL. The FTL was developed through a risk-ranking model that considered the following criteria:
- Frequency of outbreaks and occurrences of illnesses
- Severity of illnesses
- 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
Many of the foods included on the FTL are perishable commodities that require temperature control to preserve food safety or quality. As a result, the GCCA advises participants in the cold chain will need to be aware of the products on the list and whether they handle these foods in their facilities. It is important to note that the requirements apply not only to foods specifically listed on the FTL, but also to products that contain foods on the list as ingredients.
Some of the foods on the list likely to be handled by GCCA members include:
- Cheese
- Eggs
- Fruits
- Vegetables
- Seafood
The FDA also identified a list of Critical Tracking Events (CTEs) for facilities handling foods subject to the regulation. CTEs include growing, receiving, transforming, creating, and shipping. Below are FDA’s descriptions of CTEs:
Growing
For products such as fruits and vegetables, growing is generally the first step in the supply chain. In addition to the general KDEs for growing, sprout growers would be required to establish and maintain additional growing KDEs that are specific to sprouts.
Receiving
Receiving is an event in a food’s supply chain in which a food is received by a customer (other than a consumer) at a defined location after being transported (for example, by truck or ship) from another defined location. In addition to the general KDEs for receiving, ‘first receivers’ would need to establish and maintain additional KDEs.
Creating
Creating is the making or producing of a food on the Food Traceability List (for example, through manufacturing or processing) using only ingredient(s) that are not on the Food Traceability List. Creating does not include originating or transforming a food.
Transformation
Transformation is an event in a food’s supply chain that involves changing a food on the Food Traceability List, its package and/or its label (regarding the traceability lot code or traceability product identifier), such as by combining ingredients or processing a food (such as by cutting, cooking, commingling, repacking or repackaging). Transformation does not include the initial packing of a single-ingredient food or creating a food.
Shipping
Shipping is an event in a food’s supply chain in which a food is arranged for transport (e.g., by truck or ship) from a defined location to another defined location at a different farm, a first receiver or a subsequent receiver.
Some stakeholders are likely to be involved in multiple CTEs for various regulated products. When a facility conducts a CTE, it must document Key Data Elements (KDEs) related to the product and the facility’s activities. The KDEs required would vary depending on the CTE that is being performed. The records required at each CTE would need to contain and link the traceability lot code of the food to the relevant KDEs.
Below are examples of KDEs for Receiving and Shipping, two of the most common CTEs performed by GCCA members.
Receiving KDEs
- Location identifier and location description for the immediate previous source (other than a transporter) of the food
- Entry number assigned to the food (if imported)
- Location identifier and location description of where the food was received, and the date and time the food was received
- The quantity and unit of measure of the food (for example, six cases, 25 returnable plastic containers, 100 tanks, 200 pounds)
- Traceability product identifier and traceability product description for the food
- Location identifier, location description,and point of contact for the traceability lot code generator
- Reference record type(s) and reference record number(s) (for example, ‘Invoice 750A,’ ‘BOL 042520 XYX’) for the records relating to receipt of the food
- The name of the transporter who transported the food to the receiver
Shipping KDEs
- Entry number(s) assigned to the food (if imported)
- The quantity and unit of measure of the food
- Traceability product identifier and traceability product description for the food
- Location identifier, location description and point of contact for the traceability lot code generator
- Location identifier and description of the immediate subsequent recipient of the food (other than a transporter)
- Location identifier and location description for the location from which the food was shipped, and the date and time the food was shipped
- Reference record type(s) and reference record number(s) for documents relating to shipment
- Transporter’s name who transported the food from the shipper
In addition to requiring records of KDEs, the proposed rule would require facilities that manufacture, process, pack or hold foods on the FTL to establish and maintain traceability program records. These records are intended to help FDA understand a facility’s traceability program, and include:
- A description of relevant reference records
- A List of foods on the FTL that are shipped
- A description of how traceability lot codes are assigned
- Other information needed to understand data provided within the required records
Records can be maintained as either original paper records, electronic records or true copies and they all must be legible and stored to prevent deterioration or loss. When requested by FDA, traceability records must be provided no later than 24 hours after a request is made. And, during an outbreak or recall, an electronic sortable spreadsheet containing relevant traceability information must be provided to FDA within 24 hours, when requested.
The proposed rule includes a list of exemptions and partial exemptions for certain types of entities that would not be covered under the regulation. While most of the exemptions will not apply to GCCA members, there is an exemption for transporters. The proposed rule would exempt transporters of food on the FTL.
This is an initial step in the rulemaking process, and FDA is accepting public comments on the proposed rule for a period of 120 days. The compliance date is proposed to be two years after the effective date of the finalised regulation to allow time for companies to prepare for compliance with the new requirements.
GCCA will continue to work with the FDA and food industry partners throughout the rulemaking process.
This article was originally published in the Global Cold Chain Alliance’s COLD FACTS.