(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert Name:
Reason for Alert:
Additionally, an FDA investigation into a multistate outbreak spanning from 2016 through 2020 linked multiple cases of human infections with L. monocytogenes (listeriosis) to enoki mushrooms from the Republic of Korea. The outbreak accounted for a total of 36 U.S. clinical cases reported across 17 states, 12 cases in Canada, and six cases in Australia. The 36 U.S. cases yielded 31 hospitalizations and four deaths.
From March 2020 through May 2022, state public health authorities conducted sampling of enoki mushrooms from retail locations. L. monocytogenes was detected in multiple state samples, which led to 21 recalls of enoki mushrooms in the U.S. in 2021. Nine of the recalls were linked to enoki mushrooms grown in the Republic of Korea, confirmed via labeling, traceback, or whole genome sequencing (WGS). During this timeframe FDA collected and analyzed 93 samples of enoki mushrooms imported from the Republic of Korea for L. monocytogenes and found 31 violative shipments. This represents a violation rate of 33%. This represented a total of 12 firms with violative product out of 29 that had exported shipments of enoki mushrooms to the U.S.
Based on the outbreak and high sampling violation rate for the Republic of Korea, FDA believes that it is extremely unlikely that contamination of enoki mushrooms with L. monocytogenes is due to an isolated incident. Further, FDA's findings of L. monocytogenes strains with the same WGS in multiple shipments over a period of time are consistent with resident pathogens in mushroom operations in the Republic of Korea. Evidence suggests that enoki mushrooms may be a high-risk reservoir for L. monocytogenes due to the difficulty in maintaining good hygienic practices at medium-sized plants where the mushrooms are typically produced.
Accordingly, enoki mushrooms imported from the Republic of Korea appear to be adulterated under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), because they appear to contain Listeria monocytogenes, an added poisonous or deleterious substance that may render food injurious to health within the meaning of section 402(a)(1) of the FD&C Act.
Products that are intended to be processed as low-acid canned foods (LACF), acidified, or thermally processed in their final packaging are not subject to detention without physical examination under this Import Alert.
Firms found to have recurring L. monocytogenes violations under this alert may be subjected to further regulatory enforcement under Import Alert #99-35, "Detention Without Physical Examination Of Fresh Produce That Appears To Have Been Prepared, Packed, Or Held Under Insanitary Conditions," based on the appearance that their enoki mushrooms have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
Release of Articles Subject to Detention Without Physical Examination Under This Import Alert:
In order to secure release of an individual shipment subject to detention without physical examination under this import 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 L. monocytogenes. Such evidence may include private laboratory analysis of a representative sample of the detained product.
Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. For further information regarding private laboratory analyses, please reference FDA's ORA Lab Manual, volume III, section 7. Following receipt and review of private laboratory analytical results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article.
Removal from Detention without Physical Examination (ADDITION TO GREEN LIST):
In order to remove a firm's product from DWPE, information should be provided to FDA to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. FDA recommends a firm requesting removal from detention without physical examination provide documentation confirming a minimum of five (5) consecutive non-violative commercial-sized entries have been offered for import and subsequently released by FDA based on private laboratory analyses. FDA also recommends providing documentation of actions taken to prevent the problem from recurring, such as the firm's investigation into the problem and any corrective actions implemented. Such documentation may include listeria monitoring program records or sanitation monitoring program records. The purpose of this is so that 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 further guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."
If a firm and/or a representative thereof would like to be added to the Green List of 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 via email to: Importalerts2@fda.hhs.gov
All requests for addition of a firm to the Green List of this import alert should be referred by the Division of Import Operations (DIO) to CFSAN, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch for evaluation.
Questions or issues involving import operations should be addressed to the Division of Import Operations (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at firstname.lastname@example.org.
Questions or issues with regard to human food on policy, sample collection recommendations, or other any additional questions not directly related to a detained entry, should be addressed to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch at CFSANEnforcement@fda.hhs.gov
OASIS charge code: LISTERIA
KOREA (THE REPUBLIC OF)
(25 P - - 11) Enokitake Mushrooms, Whole (Button) (Fungi)Desc: Enoki Mushrooms; Seafood MushroomsNotes: excluding PICs E (commercially sterile) and I (acidified)
(25 Q - - 14) EnokitakeDesc: Enoki Mushrooms; Seafood MushroomsNotes: excluding PICs E (commercially sterile) and I (acidified)
(25 R - - 14) EnokitakeDesc: Enoki Mushrooms; Seafood MushroomsNotes: excluding PICs E (commercially sterile) and I (acidified)
(25 S - - 14) EnokitakeDesc: Enoki Mushrooms; Seafood MushroomsNotes: excluding PICs E (commercially sterile) and I (acidified)