The fruit and vegetable industry is often under the microscope during a food borne outbreak and when the evidence is strong it is always followed by a recall; some out of extreme precautionary measures and others out of necessity. History has shown whenever a commodity is implicated in a food borne outbreak, not only does the processor or farmers suffer, but the entire industry suffers.
The U.S. Food and Drug Administration is responsible for protecting public health by assuring the safety, efficacy and security of our nation’s food supply. They have set a precedent of expecting firms to take full responsibility for product recalls, including follow-up checks to assure that recalls are successful. Under the guidelines, companies are expected to notify FDA when recalls are started, to make progress reports to FDA on recalls, and to undertake recalls when asked to do so by the Agency.
Produce Traceability Initiative
Because of FDA expectation and the affect food borne implications have on the entire industry, the fresh produce industry has created the Produce Traceability Initiative. This is not a federally mandated or regulated initiative. It was developed in an effort to have everyone using the same traceability format for quicker reconciliation of products and ending outbreaks and recalls much quicker. This can be done by an operation’s personnel or by contracting any of the PTI compliant service providers.
FDA District Recall Coordinators
These federal officials have been appointed to coordinate as well as to guide an operation through a FDA Recall. It is important to know the name and contact information of an operation’s FDA District Recall Coordinator.
The “Bioterrorism Act of 2002” requires food facilities register with FDA, among other things. This is not only the law, but many food safety audits will ask operations to verify their compliance. To obtain a FDA Facility Registration number, go to the FDA website. There are step by step directions on the left menu.
FDA Reportable Food Registry
The Reportable Food Registry or RFR is an electronic portal for the food industry to report when there is reasonable probability that an article of food will cause serious adverse health consequences. Click HERE to learn more about the Reportable Food Registry and who should use it.
Definitions
Traceability:
The ‘ability to trace the history, application or location of an entity by means of recorded identifications’ as defined by The International Organization of Standardization. The FDA requirements for a tracking system must be for “one step back, one step forward.” Traceability may relate to:
The origin of produce and ingredients;
The product history; and
The distribution and location of the product after delivery.
Recall:
‘A firms removal or correction of a marketed product that FDA considers to be in violation of the laws it administers and against which FDA would initiate legal action such as seizure,’ according to the U.S. Food and Drug Administration’s 21 CFR, Section 7.3(c). Click HERE for more information about FDA Recall Guidelines, types of recalls and FDA recall classifications.
Traceability and Recall Plan:
A documented, systematic plan that indicates how an organization will track and recall produce. The system should enable trace back one step and trace forward one step to occur in the event of a recall. The plan should include procedures, recall team roles with contact information, and ready-to-use example documents such as press releases, customer contact forms, product reconciliation forms, etc.
Mock Recall:
An internal exercise to test a company’s ability to trace and recall product or ingredients using their documented traceability and recall plan. A mock recall exercise should be completed, with documentation, on at least an annual basis to ensure the traceability/recall systems work and all parties within the organization know what to do. After a mock recall, all personnel should come together to assess effectiveness by identifying and correcting deficiencies. Begin a mock recall by developing a scenario (real or fictional) in reference to an affected lot or affected trailer load. An operation then follows the traceability and recall plan. The mock recall should be completed within 2 hours having as close to 100% reconciliation of all implicated lots, including culls cash sales. Make copies of all supporting materials (shipping records, production records, etc.) to show how reconciliation occurred. BE SURE TO WRITE OR STAMP THE PHRASE, “MOCK RECALL,” ACROSS ALL COPIES OF SUPPORTING MATERIALS. There is no need to cause anxiety or a market crash because fictional information got into the wrong hands.
Click HERE to go to Primus Labs’ Manual Development Toolkit. This free tool includes a very good, generic recall and traceability plan, including documentation examples, that can be edited for a specific operation.
