This import alert represents the Agency’s current guidance to the Food and Drug Administration (FDA) field personnel regarding the manufacturer(s) and/or product(s) at issue. It does not create or confer any rights for or any person, and does not operate to bind FDA or the public.
Produce is vulnerable to contamination with pathogenic microorganisms if exposed to insanitary conditions during growing, harvesting, packing, holding, or manufacturing, processing, or transportation. Multiple foodborne illness outbreaks have been linked to produce items that were likely contaminated as a result of insanitary conditions during growing, harvesting, packing, holding, manufacturing, processing, or transportation. Produce is of special concern because in many instances it is consumed without further treatment to adequately destroy or remove pathogenic microorganisms.
FDA may document insanitary conditions during an inspection of an establishment that grows, harvests, packs, holds, manufactures, processes, or transports produce. FDA may also use analytical evidence or epidemiological and traceback evidence to establish that a produce item was manufactured, processed, prepared, packed, or held under insanitary conditions.
Districts may detain, without physical examination, produce items from manufacturers, shippers, farms, packers and/or other entities (firms) identified on the Red List of this import alert.
Examples of evidence FDA may use to place a firm on the Red List include:
- Inspectional evidence.
- Epidemiological evidence and traceback evidence. This should include evidence implicating the particular produce item as a vehicle in a foodborne illness outbreak (including positive test results), traceback evidence demonstrating that the firm grows, harvests, packs, holds, manufactures, processes, or transports the implicated vehicle, and expert opinion that the outbreak was likely a result of insanitary conditions at the foreign firm (e.g., contamination likely resulted from insanitary conditions due to the typical modes of transmission of the pathogen implicated in the outbreak) or was related to a resident pathogen or systemic contamination at the foreign firm, or both.
- Analytical evidence. This should include evidence of a resident organism at the foreign firm and/or systemic contamination at the foreign firm, such as an expert opinion that the analytical evidence indicates insanitary conditions at the foreign firm or indicates a resident pathogen or systemic contamination at the foreign firm, or both. Examples include:
* A pathogen that matches an outbreak strain is isolated from an imported produce item;
* Microbial pathogens that are indistinguishable by one or more genetic tests are isolated from two or more lots of imported produce originating from the same foreign firm.
INFORMATION FOR FIRMS REQUESTING REMOVAL FROM THE RED LIST:
In order to be removed from the red list, the firm should submit documentation to FDA demonstrating that the firm has made all relevant corrections to overcome the appearance of adulteration, so that the agency will have confidence that future entries will be in compliance with the Act. Examples of such documentation may include:
- Documentation to show that inspectional observations or violations identified by FDA have been corrected. Firms whose produce items appear to be adulterated based on inspectional evidence should submit detailed descriptions of the specific steps taken to correct the violations along with documentation such as (as applicable) written plans, field records, packinghouse or facility records, training records, and photographs.
- Root cause analysis to identify potential sources and routes of contamination. Firms whose produce items appear to be adulterated based on analytical or epidemiological and traceback evidence should include a detailed root cause analysis to evaluate all aspects of their operations in order to identify potential sources and routes of contamination. The firm should also provide documentation to demonstrate that corrective actions to adequately control the sources and routes of contamination identified in the root cause analysis have been implemented.
FDA recommends that the firm’s submission be organized according to the following areas, as appropriate to the firm’s practices, processes, and procedures:
– Water adequacy for irrigation, agricultural sprays, cooling, and other uses;
– Soil amendment and biosolids;
– Animal management;
– Worker health and hygiene;
– Sanitary facilities, disposal of sewage and silage;
– Equipment cleaning and sanitation;
– Farm or facility sanitation;
– Transportation; and
– Programs to monitor produce safety practices, processes and procedures and to take corrective actions when measures fail or are not fully implemented.
The firm may wish to refer to FDA’s Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, or similar guidance, to assist them in their root cause analysis and corrective action. Additional guidance for produce, including commodity specific guidance, may be found the FDA website at www.FDA.gov.