Import Alert 23-12

Import Alert # 23-12

Published Date: 11/20/2023

Type: DWPE

"Detention Without Physical Examination of Coconut Due to the Presence of Microbiological Contamination"

Note: The revision of this Import Alert (IA) dated 09/14/2023 updates the guidance section. Changes to the import alert are bracketed by asterisks (***).

On September 6, 1991, Baltimore District was informed by the Maryland Department of Health of an outbreak of cholera. Three individuals became ill and were found to be infected with toxigenic Vibrio cholerae O1, biotype El Tor, serotype Ogawa. The product implicated in this outbreak was a dessert made with coconut milk.

A number of different products were collected by Baltimore district as a result of a follow-up investigation; laboratory analysis of a sample of fresh frozen coconut milk identified the presence of toxigenic V. Cholerae O1, serotype Ogawa. The product was also found to contain Salmonella.

In 2008, a sample of shredded coconut manufactured in India, was collected, and analyzed and found to contain Listeria monocytogenes, Type 4.

Divisions may detain, without physical examination, all shipments of the specified coconut product(s) from the firms listed in the Red List below due to the presence of microbiological contamination, using the appropriate charges as noted.

Recommendations for additions to the Red List of this import alert, that are due to findings of Salmonella, should be forwarded directly to the Division of Import Operations (DIO).

Additions to the Red List of this import alert as a result of Listeria monocytogenes or Vibrio cholerae findings will require a review by both DIO and the Center. If other strains of Vibrio are encountered, these findings will be reviewed on a case-by-case basis by the Center.

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 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 the presence of microbiological contamination. Such evidence could include private laboratory analysis of a representative sample(s) collected from the affected article.

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. ***

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 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). For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention Without Physical Examination (DWPE)."

If a firm and/or a representative thereof would like to petition for removal from detention without physical examination 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

Questions or issues involving import operations should be addressed to ORA/DIO at (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 on policy, sample collection recommendations, or any other 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

                                                                                                                                                                        

All fresh, frozen and dried products containing coconut milk or coconut meat. NOTE: This does not include thermally processed canned products

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

OASIS charge code: VIBRIO

and/or

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

OASIS charge code: SALMONELLA

and/or

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it 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: Coconut

Notes: 3/13/06

Desc: Coconut

Desc: Coconut

Desc: Coconut

Desc: Coconut

Desc: Dessicated Coconut Coconut Milk

Notes: 7/23/1992; Problem; V.Cholerae

Desc: Dessicated Coconut Coconut Milk

Notes: 7/23/1992; Problem; V.Cholerae

Desc: Dessicated Coconut Coconut Milk

Notes: 7/23/1992; Problem; V.Cholerae

Desc: Dessicated Coconut Coconut Milk

Notes: ;7/23/1992; Problem; V.Cholerae

Desc: Dessicated Coconut Coconut Milk

Notes: 7/23/1992; Problem; V.Cholerae

Desc: Dessicated Coconut Coconut Milk

Notes: 7/23/1992; Problem; V.Cholerae

Desc: Desiccated Coconut

Notes: 10/7/1997

Desc: Desiccated Coconut

Notes: 10/7/1994

Desc: Dried Coconut

Desc: Coconut Powder

Desc: Coconut Powder

Desc: Coconut

Notes: 5/13/03

Desc: Coconut Cuts

Desc: Grated Coconut (Fresh and Frozen)

Desc: Grated Coconut (Fresh and Frozen)

Desc: Grated Coconut (Fresh and Frozen)

Desc: Coconut Cuts

Desc: Shredded Coconut

Desc: Shredded Coconut

Desc: Shredded Coconut

Desc: Coconut

Notes: 5/19/03

Desc: Shredded Coconut

Notes: 8/28/2007

Desc: Mashrouha Marzipan

Desc: Mashrouha Marzipan

Desc: Yellow Coconut Candy

Desc: Yellow Coconut Candy

Desc: Yellow Coconut Candy

Desc: Yellow Coconut Candy

Desc: Grated Coconut

Desc: Shredded Coconut

Notes: Problem: Vibrio Cholera

Desc: Grated Coconut

Desc: Shredded Coconut

Desc: Shredded Coconut

Desc: Shredded Coconut

Desc: Dried Shredded Coconut

Desc: Dried Shredded Coconut

Desc: Coconut

Desc: Coconut

Desc: Coconut

Desc: Coconut

Desc: COCONUT CHIPS

Desc: Coconut

Desc: Coconut

Desc: Frozen Coconut; Sliced

Desc: Coconut

Desc: Frozen/Refrigerated Coconut Cake

Notes:                                                                                                         

Desc: Frozen/Refrigerated Coconut Cake

Notes:                                                                                                         

Desc: Frozen/Refrigerated Coconut

Notes:                                                                                                         

Desc: Frozen/Refrigerated Young Coconut

Notes:                                                                                                         

Desc: Frozen/Refrigerated Coconut

Notes:                                                                                                         

Desc: Frozen/Refrigerated Coconut

Notes:                                                                                                         

Desc: Frozen Shredded Coconut

Desc: Frozen Shredded Coconut