Import Alert 16-137

(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 # 16-137
Published Date: 03/21/2020
Type: DWPE

Import Alert Name:

DETENTION WITHOUT PHYSICAL EXAMINATION OF SEAFOOD DUE TO HEPATITIS A CONTAMINATION

Reason for Alert:

NOTE: The revision to this Import Alert dated March 20, 2020 updates the ‘Guidance’ section with addition of procedure for removal from Red List and addition to Yellow List and contact information for further questions or guidance. Changes are noted and bracketed by asterisks (***).

In May 2017, the FDA sampled/analyzed frozen raw tuna products and found that they contained Hepatitis A virus. Follow up FDA screening found a second firm’s raw frozen tuna contained Hepatitis A virus.

Hepatitis A virus is primarily transmitted by person-to-person contact through the fecal-oral route and by the consumption of contaminated food or water. Foods can be contaminated by infected workers in food production facilities/processing plants and restaurants. No known non-human sources of the virus exist. FDA believes that hepatitis A virus contaminated seafood is a result of gross insanitary conditions in the production or packing facilities, e.g., poor worker hygiene, inadequate worker sanitation facilities, and/or contaminated water supply.

Guidance:

Divisions may detain, without physical examination, shipments of fresh or frozen raw seafood from the firms identified on Red List of this Alert.

This alert EXCLUDES LACF (canned and pouched) seafood products (i.e. products with a scheduled process on file with CFSAN per 21 CFR 113).

Recommendations for additions to the Red List should be forwarded to the Division of Import Operations (DIO). DIO and FDA’s Center for Food and Safety and Applied Nutrition (CFSAN) will evaluate regulatory packages on a case-by-case basis.

Requests for Removal from Detention without Physical Examination under This Import Alert:

Per FDA's regulatory procedures manual (RPM) Chapter 9-8 "Detention without Physical Examination (DWPE),” in order for FDA to consider removing a firm and/or product from detention without physical examination, FDA must have evidence which establishes the conditions that gave rise to the apparent violation have been resolved and which gives FDA confidence that future entries will be in compliance with the Act. Therefore, it is expected the firm and/or an agent thereof will submit information outlining the firm's investigation into the root cause of the violation as well as any follow-up steps taken to prevent violations in future shipments.

In addition, a minimum of five (5) consecutive non-violative, commercial shipments should be offered for import into the United States (and found to be in compliance) before the FDA may consider that the appearance of the violation has been overcome, and that it may be appropriate to remove the firm/product combination from 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 forward 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

The application for removal from DWPE should be in English and include the following:
1. The root cause analysis that identifies the source of the
contamination.
2. Written corrective actions taken to eliminate the source of the
contamination, including sanitation standard operating procedures (SSOPs)that are intended to prevent reoccurrence of contamination, the monitoring records documenting the implementation of the SSOPs, and verification procedures. SSOPs may include the following applicable items:
a. Water quality;
b. Controls for worker health and hygiene (e.g., training and monitoring for proper hand washing, monitoring of employees for symptoms, hepatitis A vaccine);
c. Maintenance of hand washing and toilet facilities;
d. Sanitary facilities in receiving and processing;
e. Condition and cleanliness of food contact surfaces (e.g., visual inspection of gloves, outer garments and utensils);
f. Maintenance program for cleaning and sanitizing equipment;
g. Transportation practices
3. The HACCP plan and 5 days’ worth of monitoring records.

Once FDA has reviewed the submitted documents and finds them to be adequate, then the firm will be added to the Yellow List.

The purpose of the Yellow List is to alert the field to the names of the firms for which the FDA has agreed to allow to ship. The firms named in the Yellow List will be required to make five entries and provide laboratory results that are negative for Hepatitis A.

Once the firm has five consecutive shipments shown to be free of Hepatitis A, the firm and/or a representative should submit a request to DIO to have the firm removed from the Yellow List, which removes the firm from DWPE.***

***

***For questions or issues involving import operations, contact ORA’s Division of Import Operations at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.

Questions or issues involving OASIS or PREDICT screening should be addressed to ORA/DSS/Import Systems Branch at oraoismdssimpcomplsysbr@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.

Resources for private laboratory testing are available at https://www.fda.gov/media/73540/download

For questions on policy or sample collection recommendations contact CFSAN, Division of Enforcement, Food Adulteration Assessment Branch at (240) 402-1750 or CFSANEnforcement@fda.hhs.gov.***

Product Description:

RAW SEAFOOD, FRESH and/or FROZEN

PROBLEM(S): HEPATITIS A

Charge:

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

OASIS charge code – HEPATITISA***

And,

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

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

Countries

MULTIPLE COUNTRIES (PODS ONLY)

  • (16 - - - --) Fishery/Seafood Prod
    Desc: RAW SEAFOOD; FRESH and/or FROZEN

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


MEXICO


ARTURO MANUEL ROMANDIA TOYOS
Date Published : 01/11/2019
Caguama 332 , Col. Las Delicias , Guaymas, Sonora MEXICO
16 J - - 01 Crab
Date Published: 01/11/2019

Desc: Crab

Congeladora Don Crispin S.A. de C.V.
Date Published : 01/11/2019
Lote 7 Manzana 33 S/N , Las Playitas 1 , Guaymas, MX-SON MEXICO
16 J - - 01 Crab
Date Published: 01/11/2019

Desc: Crab

Congeladora Don Crispin S.A. de C.V.
Date Published : 01/11/2019
Lote 7 Manzana 33 S/N , Las Playitas 1 , Guaymas, MX-SON MEXICO
16 J - - 01 Crab
Date Published: 01/11/2019

Desc: Crab


PHILIPPINES


SANTA CRUZ SEAFOODS, INC.
Date Published : 02/08/2018
Gen. Santos Fishport Complex , Tambler , South Cotabato, Socsargen PHILIPPINES
16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 02/08/2018

Desc: Tuna


VIETNAM


Sustainable Seafood Co., Ltd.
Date Published : 12/13/2017
Lot F5-6 Suoi Dau Industrial Zone , Cam Lam, Khanh Hoa VIETNAM
16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 12/13/2017

Desc: fresh or frozen raw tuna