In September 2020, FDA published the last of its proposed Food Safety & Modernization Act rules. Called “Requirements for Additional Traceability Records for Certain Foods,” the proposed rule immensely alters the traceability system for high-risk foods.
At a virtual public hearing in October 2020, Frank Yiannas, FDA’s deputy commissioner for food policy & response, said, “The Traceability Rule will strengthen food protection for generations to come. It is the pillar of the New Era of Modern Food Safety Initiative,” adding “our Achilles heel has been a lack of traceability.”
Specialty Foods on High-Risk List
FDA has been working since 2014 to identify foods that are “high risk.” Those that made the Food Traceability List (FTL) include “cheeses (other than hard cheese), shell eggs, nut butters, cucumbers, fresh herbs, leafy greens, melons, peppers, sprouts, tropical tree fruits, fresh cut fruits and vegetables, fin fish (including smoked), crustaceans, mollusks and ready-to-eat deli salads.”
Products that contain these foods as ingredients are also impacted by the traceability rule. In other words, if your specialty food contains mango, eggs, shrimp, and so on, you are required to implement the traceability system.
Those who manufacture, process, pack, or hold foods on the FTL are required to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs). Each would be assigned a Traceability Lot Code.
FDA defines CTEs as:
Growing: First step in the supply chain
Receiving: A food is received by a customer at a defined location after transport. The First Receiver at this location is responsible for maintaining certain KDEs
Creating: Making or producing of a food on the FTL using only ingredients that are not on the FTL
Transforming: Changing a food on the FTL, its package, or its label by combining ingredients or processing
Shipping: Food being transported from one location to another
KDEs must be recorded at all of these steps, except growing. The KDEs 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.
These records must be provided to FDA no later than 24 hours after a request. If the request is due to an outbreak, recall, or other threat to public health, the records must be provided in an electronic sortable spreadsheet.
This ambitious system would require extensive record-keeping transformation and upgrades, especially for small and very small manufacturers, importers, and distributors.
An Outcry from the Industry
FDA held virtual public hearings in October, November, and December 2020, in the Eastern, Central, and Pacific time zones. There were presentations from FDA officials, state officials, trade associations, and consumer interest groups, followed by public comments.
The complexity of the regulations and the cost to comply was addressed by many trade associations, including the Specialty Food Association. SFA expressed concern about the general categories of foods for exclusion on the FTL. SFA also requested an extended and phased timeline for implementation based on business size and type and questioned a lack of training programs regarding the rule.
The deadline for written comments was February 22, 2021. More than 5,000 comments were submitted, from food trade associations, grower organizations, and consumer interest groups.
Industry Questions and Concerns
FDA clarified some of the ambiguities about products on the FTL in January. For instance, cheeses subject to the FTL were those with more than 39 percent moisture content. The word fresh was added to fruits and vegetables on the list. For instance, dried mangoes would not be considered high-risk whereas fresh mangoes would be.
In a 7,500-plus word statement, SFA expressed the concerns of the specialty food industry. SFA requested that FDA:
1. Revisit the determination of listed foods to list particular foods – not broad categories of food.
2. Establish requirements for labeling of foods exempt or no longer subject to the rule to reduce the burden on receiving entities.
3. Consider complexities presented for implementing this rule under common commercial arrangements in the specialty food industry.
4. Eliminate the collection of burdensome, often duplicative information that is not necessary to trace back.
5. Respect data privacy and confidentiality concerns of firms and limit the collection of information to better safeguard sensitive commercial information.
6. Follow the statutory mandate not to prescribe particular technologies.
7. Establish education requirements and dedicate resources for education.
8. Increase and establish a phased timeline for compliance.
9. Clarify mechanisms for enforcement by FDA with different entities in the supply chain.
10. The Association requests that FDA clarify retail entities subject to the rule's overall mechanisms for the enforcement of the rule.
Identify Particular Foods, Not Food Categories
SFA believes that the FTL is overly inclusive because it is based on a category approach rather than specifying particular foods. For instance, bananas are a tropical tree fruit and would thus be on the FTL, even though they are rarely implicated in foodborne illness. FDA examples of Ready-to-Eat Deli Salads include egg salad, potato salad, seafood salad, and others made with mayonnaise. But delis today offer hundreds of combinations, such as olives, meat and cheese or tofu and beans. Would all of these be subject to the traceability rule?
SFA also believes that the collection of redundant and duplicative information will increase the cost of compliance, adversely affecting small and very small businesses. The comments state, “FDA has proposed a duplicative, burdensome system which undermines the key statutory purpose of creating an efficient and effective end-to-end traceback.”
The American Cheese Society, which represents 2,100 cheese makers, distributors, and retailers, stresses that its small and very small members would not have the technology to supply FDA with a sortable electronic spreadsheet within 24 hours. SFA agrees that many small businesses are not able to afford these technologies and that they may stop handling food on the traceability list. This is contrary to the Congressional intent that the traceability system “be scale-appropriate and practicable to facilities of varying sizes and capabilities.”
FDA has stated that companies will have two years to comply after the publishing of the final rule in November 2022. SFA has requested that the timeline mirror that of the Preventive Controls for Human Food regulation, with a one-year extension for small businesses, defined as companies with fewer than 500 employees.
Although compliance with the “Requirements for Additional Traceability Records for Certain Foods” seems distant, it will become an enforced regulation before many in the industry have time to understand and comply with it.
Ron Tanner is president of Tanner Food Group and former vice president of education, content & advocacy for the Specialty Food Association.
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