"Detention Without Physical Examination of Cheese Due to Microbiological Contamination"

Reason for Alert

NOTE: The revision of this Import Alert, dated 06/04/2025, updates the alert to include additional guidance on removal from Detention Without Physical Exam (removal from the red list) under this import alert and Agency contacts. Changes to the import alert are bracketed by asterisks (***). Since the implementation of this import alert in 1996, the Agency continues to sample and analyze imported cheese for microbiological contamination. The Red List of this alert includes manufacturers whose products have been found to be violative due to the presence of Salmonella, Listeria monocytogenes (L. monocytogenes), enterotoxigenic Escherichia coli (E. coli), enterohemorrhagic E. coli, Staphylococcal enterotoxin, and/or ***Staphylococcal aureus at levels of 10,000 CFU/g or greater***. NOTE: The import alert does not include soft and soft ripened cheese from France found to contain Listeria monocytogenes (LM). For Guidance on these violative findings refer to Import Alert #12-03, "Detention Without Physical Examination of Imported Soft Cheese and Soft Ripened Cheese from France."

Product Description

All cheese and cheese products (See exception in the Reason for Alert.)

Charge

For Salmonella, Listeria monocytogenes, enterohemorrhagic E. coli, enterotoxigenic E. coli, and Staphylococcal enterotoxin **use only the below** charge: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. [Adulteration, Section 402(a)(1)]. Contains: OASIS CHARGE CODE(s): POISONOUS and/or For ***Staphylococcal aureus at levels of 10,000 CFU/g or greater*** use only the below charge: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. [Adulteration, Section 402(a)(4)]. OASIS CHARGE CODE: INSANITARY

Guidance

Divisions may detain without physical examination, the specified cheese and cheese product(s) from the manufacturers identified on the Red List of this import alert. Recommendations for additions to the Red List of this import alert for enterotoxigenic Escherichia coli (E. coli), enterohemorrhagic E. coli, and/or ***Staphylococcal aureus at levels of 10,000 CFU/g or greater, should be forwarded to the Division of Import Operations (DIO) and FDA's Human Foods Program(HFP) will evaluate regulatory packages on a case-by-case basis.*** Release of Articles Subject to Detention Without Physical Examination Under This Import Alert: ***NOTE: The following applies to entries from firms identified on the Red List of the alert with violative findings of Salmonella, Listeria monocytogenes, enterohemorrhagic E. coli, and enterotoxigenic E. coli*** In order to secure release of an individual shipment subject to detention without physical examination under this alert, the owner, consignee and/or other responsible party for the affected goods should provide evidence which demonstrates that the product does not bear or contain microbiological contamination. Such evidence could include private laboratory analysis of a representative sample(s) collected from the affected article. *** Beginning 12/02/2025 for analyte group Listeria, food testing in support of admission of an article of food detained under section 801(a) of the Federal Food, Drug, and Cosmetic Act must be conducted by a Laboratory Accreditation for Analyses of Food (LAAF)-accredited laboratory (21 CFR 1.1107). The LAAF-accredited laboratories capable of conducting analysis for this analyte group are available at: https://datadashboard.fda.gov/ora/fd/laaf.htm *** ***Beginning 10/23/2026 for analyte group Staphylococcus, food testing in support of admission of an article of food detained under section 801(a) of the Federal Food, Drug, and Cosmetic Act must be conducted by a Laboratory Accreditation for Analyses of Food (LAAF)-accredited laboratory (21 CFR 1.1107). The LAAF-accredited laboratories capable of conducting analysis for this analyte group are available at: https://datadashboard.fda.gov/ora/fd/laaf.htm *** Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, Volume III, Section 7. Following receipt and review of analytical results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article ***NOTE: The following applies to entries from firms identified on the Red List of the alert with findings of Staphylococcal aureus at levels of 10,000 CFU/g or greater*** The article is subject to Refusal of Admission per Section 402(a)(4) of the Act, and therefore 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. Removal from Detention Without Physical Examination (REMOVE FROM RED LIST): In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of a violation. The purpose of this is so the agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention Without Physical Examination (DWPE)." ***Examples of such documentation for products with Staphylococcal aureus at levels of 10,000 CFU/g or greater may include: 1. Documentation of a root cause analysis to identify potential sources and routes of contamination. Firms whose RTE food products 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 to identify potential sources and routes of contamination. For example, a. Documentation to demonstrate that corrective actions to adequately control the sources and routes of contamination identified in the root cause analysis have been implemented; and/or b. Documentation showing that a minimum of five (5) non-violative product samples (representative of a lot) have been analyzed by third-party laboratory as further verification that the products do not contain microbial pathogens and that corrective actions have been adequately implemented. 2. A written Food Safety Plan, including a written hazard analysis identifying hazards requiring a preventive control; written preventive controls; written procedures for monitoring, corrective actions, and verification; validation of any process controls; written recall plan if required; to prevent the food from becoming adulterated. In addition, after reviewing these submissions, an FDA, foreign competent authority, or third-party inspection of the manufacturing facility may be necessary to verify the validity of the information submitted to FDA, before considering removal of the firm from the Red List.*** ***If a firm and/or a representative thereof would like to submit a petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be sent via email to: Importalerts2@fda.hhs.gov Questions or issues involving import operations, contact 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 HFP/Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to FDAPRIVATELABIMPORTALERTS@fda.hhs.gov ***

Affected Countries (1)