Note: The revision of this Import Alert (IA) dated 05/10/2024 updates the reason for alert, guidance section including agency contacts, and product description. Changes to the import alert are bracketed by asterisks (***). Produce is vulnerable to contamination with pathogenic microorganisms if exposed to insanitary conditions during growing, harvesting, packing, holding, manufacturing, processing, or transportation. Multiple foodborne illness outbreaks have been linked to produce **that was*** 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 that may have resulted in the contamination of produce with human pathogens 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 produce was grown, harvested, packed, held, manufactured, processed, or transported under insanitary conditions that may have resulted in contamination of the produce with human pathogens.***
*** Produce (fruit or vegetable)***
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that such article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. [Adulteration, Section 402(a)(4)] OASIS charge code: MFR INJ and The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions. [Adulteration, Section 402(a)(4)] OASIS charge code: MFR INSAN
***Divisions may detain without physical examination, produce from foreign 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: 1. ***Inspectional evidence demonstrating that produce has been grown, harvested, packed, held, manufactured, processed, or transported under insanitary conditions whereby it may have become contaminated with pathogens. 2. Epidemiological evidence, traceback evidence, and expert opinion. This should include: � evidence confirming a particular produce vehicle in a foodborne illness outbreak, � traceback evidence demonstrating that the firm grows, harvests, packs, holds, manufactures, processes, transports, and/or offers for entry, the confirmed produce vehicle, and � expert opinion that the outbreak was likely a result of insanitary conditions in the foreign supply chain (grower, harvester, packer, holder, manufacturer, processor, transporter, or the supplier to the domestic importer; or that the outbreak was related to a resident pathogen and/or systemic contamination in the foreign supply chain. 3. Analytical evidence. This should include evidence of a resident pathogen in the foreign supply chain, systematic contamination, or direct or indirect contamination of produce with human feces prior to importation. These findings should be supported by expert opinion that the analytical evidence indicates that the contamination resulted from insanitary conditions in the foreign supply chain. Examples include: - A pathogen that matches, by one or more genetic tests, an outbreak strain isolated from imported produce in conjunction with traceback and epidemiological evidence confirming the produce as a vehicle. - Microbial pathogens that are indistinguishable by one or more genetic tests, are isolated from multiple lots of imported produce originating from the same foreign firm with expert opinion that the pathogen is a resident pathogen or a result of a systemic contamination at the foreign firm. - A single Norovirus or hepatitis A virus product positive. - A single Cyclospora cayetanensis product positive. All requests for addition to DWPE will be evaluated by the Division of Import Operations (DIO) and the Center for Food Safety and Applied Nutrition (CFSAN), Office of Compliance, Division of Enforcement. NOTE: Since the article is subject to Refusal of Admission per Section 801(a)(1) of the Act, FDA considers submission of analytical results to be insufficient to overcome the appearance of the product having been prepared, packed, or held under insanitary conditions. In addition, the appearance of a violation per Section 801(a)(1) of the Act precludes reconditioning under Section 801(b) of the Act.*** Removal from Detention Without Physical Examination (REMOVE FROM RED LIST): ***To remove a firm's product from the Red List, evidence should be provided to the agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so the agency will have confidence that future entries will be in compliance with the Federal Food, Drug, and Cosmetic Act (i.e., the Act). Firms are placed on this import alert based on evidence of insanitary conditions, therefore five (5) consecutive non-violative commercial shipments are not considered to be sufficient evidence to overcome the appearance of adulteration. For guidance on removal from detention without physical examination (DWPE), refer to FDA's Regulatory Procedures Manual, Chapter 9-8-15, "Removal From Detention without Physical Examination." Examples of such documentation may include: 1. Documentation to show that inspectional observations or violations identified by FDA have been corrected. Firms whose produce appears 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 written plans, field records, results from testing raw materials for hazards, third-party inspection audit results relating to the safety of the food, packinghouse or facility records, training records, and photographs (as applicable). 2. Root cause analysis to identify potential sources and routes of contamination. Firms whose produce appears 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, procedures and as appropriate to the pathogen(s): - Water adequacy for irrigation, agricultural sprays, washing, packing, 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. FDA has published "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption", 21 CFR part 112, the produce safety rule. The produce safety rule establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. The firm may wish to refer to this rule and applicable 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. If a firm and/or a representative thereof would like to petition for removal from DWPE under this import alert, all relevant information supporting the request should be forwarded to the following address: Food and Drug Administration Division of Import Operations 12420 Parklawn Drive, ELEM-3109 Rockville, MD 20857 Or, be sent via email to: Importalerts2@fda.hhs.gov Requests for removal from DWPE will be referred by DIO to CFSAN, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch for evaluation. *** FDA may also choose to evaluate the firm's corrective actions during an inspection of the firm. *** Questions or issues involving import operations should be addressed to OII Division of Import Operations (DIO) at (301) 796-0356 or Imports@fda.hhs.gov. Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to the Human Foods Program Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov ***
This alert authorizes Detention Without Physical Examination (DWPE) for products matching this alert. Reason: Note: The revision of this Import Alert (IA) dated 05/10/2024 updates the reason for alert, guidance section including agency contacts, and product description. Changes to the import alert are bracketed by asterisks (***). Produce is vulnerable to contamination with pathogenic microorganisms if exposed to insanitary conditions during growing, harvesting, packing, holding, manufacturing, processing, or transportation. Multiple foodborne illness outbreaks have been linked to produce **that was*** 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 that may have resulted in the contamination of produce with human pathogens 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 produce was grown, harvested, packed, held, manufactured, processed, or transported under insanitary conditions that may have resulted in contamination of the produce with human pathogens.***
Country-specific information is available in the full alert detail on the FDA website.
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