Import Alert 25-21

Import Alert # 25-21

Published Date: 11/08/2023

Type: DWPE

Detention Without Physical Examination of Enoki Mushrooms from the Republic of Korea and China due to Listeria Monocytogenes

Note: The revision of this Import Alert (IA) dated 03/01/2023 updates the import alert name to include the country of China. Additional updates are also made to the reason for alert section, the guidance section, product description, and countries section. Changes to the import alert are bracketed by asterisks (***).

***During fiscal years 2021-2023, FDA sampled and analyzed enoki mushrooms (also known as enokitake, seafood, golden needle, futu, or lily mushrooms) imported from a number of countries. At the time of the initial issuance of this alert, FDA analysis found that 43% of sampled enoki mushrooms from the Republic of Korea were contaminated with Listeria monocytogenes (L. monocytogenes), a human pathogen. At the time of the addition of the country of China to this alert, FDA analysis found that 15% of sampled enoki mushrooms from China were contaminated with L. monocytogenes.***

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. ***In November 2022, an FDA investigation into a multistate outbreak accounting for three cases of human infections with listeriosis was linked to enoki mushrooms labeled as a product of China.***

***From October 2020 through January 2023, state public health authorities conducted sampling of enoki mushrooms from retail locations. L. monocytogenes was detected in multiple state samples, which led to 18 recalls of enoki mushrooms in the U.S. since 2021. Eight of the recalls were linked to enoki mushrooms grown in the Republic of Korea, and 10 from China, confirmed via labeling, traceback, or whole genome sequencing (WGS). During this timeframe FDA sampled and analyzed 91 shipments of enoki mushrooms imported from the Republic of Korea for L. monocytogenes and found 24 to be violative. This represents a violation rate of 26%. Additionally, FDA sampled and analyzed 111 shipments of enoki mushrooms imported from China and found 16 to be violative. Additional sampling performed as part of the November 2022 outbreak response resulted in a 15% violation rate. This effort identified a total of 12 firms with violative product out of 29 declared to have exported enoki mushrooms from the Republic of Korea to the U.S., and 12 firms with violative product out of 26 declared to have exported enoki mushrooms from China to the U.S.***

Based on the outbreak and high sampling violation rate for the Republic of Korea and China, 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 suggest that there may be resident pathogens in mushroom operations in the Republic of Korea and China.*** Evidence suggests that enoki mushrooms may be a high-risk reservoir for L. monocytogenes due to difficulty maintaining good hygienic practices at medium-sized plants where the mushrooms are typically produced.

Accordingly, enoki mushrooms imported from the Republic of Korea ***and China*** 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.

Divisions may detain without physical examination, all raw and raw fresh refrigerated enoki mushrooms ***(also known as enokitake, seafood, golden needle, futu, or lily), including frozen***, sliced, chopped, or diced enoki mushrooms, offered for importation from the countries of the Republic of Korea ***and China***, except from those firms identified on the Green List of this Import Alert.

*** Enoki mushrooms are also known as: enokitake, seafood, golden needle, futu, or lily mushrooms, and any entries declared as such, are subject to detention without physical examination (DWPE), per this alert.***

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 (DWPE), per 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 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 DWPE 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 FD&C Act.

For further guidance on removal from DWPE, 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 petition for removal from DWPE under this import alert (addition to Green List), 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 IA 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 oraorsprivatelabimportalerts@fda.hhs.gov.

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

                                                                                                                                                               

Enoki Mushrooms; Seafood Mushrooms; ***Enokitake; Seafood; Golden Needle; Futu; Lily***

"The article is subject to refusal of admission pursuant to Section 801(a)(3), in that the article
appears to contain Listeria monocytogenes, a poisonous and deleterious substance, which may
render it injurious to health." [Adulteration, Section 402(a)(1)]

OASIS charge code: LISTERIA

Desc: Enoki Mushrooms

Desc: Enoki Mushrooms

Desc: Enoki Mushrooms

Desc: Enoki Mushrooms